New Drugs 2011

Abstral for cancer pain

Abstral (Fentanyl) - ProStraken - This is an immediate release dose form of an older analgesic drug. It is taken by dissolving the transmucosal tablets on the soft surfaces of the mouth. It it to be used only in those patients with breakthrough pain due to cancer. Common side effects include; nausea, constipation, drowsiness and headaches.

Adcetris for Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL).

Adcetris (brentuximab vedotin) - Seattle Genetics - This drug has been recently approved to treat Hodgkin lymphoma (HL) and a rare lymphoma known as systemic anaplastic large cell lymphoma (ALCL). Adcetris is an antibody-drug conjugate that combines an antibody and drug, allowing the antibody to direct the drug to a target on lymphoma cells known as CD30. In patients with HL treated with Adcetris. Seventy-three percent of patients achieved either a complete or partial response to the treatment. On average, these patients responded to the therapy for 6.7 months. In patients with systemic ALCL Adcetris was evaluated in 58 patients. Of the patients receiving Adcetris for ALCL, 86 percent experienced either a complete or partial response and responded on average for 12.6 months. Common side effects were a decrease in infection-fighting white blood cells (neutropenia), nerve damage (peripheral sensory neuropathy), fatigue, nausea, anemia, upper respiratory infection, diarrhea, fever, cough, vomiting, and low blood platelet levels (thrombocytopenia).

Afinitor for advanced pancreatic cancer

Afinitor (Everolimus) - Novartis - This is a significant advance in the treatment of non- operable neuroendocrine tumors located in the pancreas. In patients treated with Afinitor, the median length of time they lived without the cancer spreading or worsening was 11 months compared with 4.6 months in patients who received placebo. The most common sideeffects included inflammation of the mouth (stomatitis), rash, diarrhea, fatigue, swelling (edema), stomach (abdominal) pain, nausea, fever, and headache.

Afinitor is also approved to treat patients with kidney cancer (advanced renal cell carcinoma) after they fail treatment with Sutent (sunitinib) or Nexavar (sorafenib); and patients with subependymal giant cell astrocytoma (a type of brain cancer) associated with tuberous sclerosis (a disease that causes tumors in various parts of the body), who cannot be treated by surgery.

Arcapta for Chronic Obstructive Pulmonary Disease

Arcapta (Indacaterol) - Novartis - Arcapta has been approved by the FDA for the long-term once-daily inhalation treatment of Chronic Obstructive Pulmonary Disease (COPD). When airway obstruction is produced by constriction of the bronchioles, Arcapta produces relaxation of the bronchiolar walls thus easing the effort of breathing. It acts by stimulating the beta-2 receptors in the lung. The most common side effects are: runny nose, cough, sore throat, headache and nausea.

Aridol for diagnosis of asthma

Aridol (Mannitol) - Pharmaxis - Aridol is the second drug given by inhalation for the diagnosis of asthma. Unlike the methacholine test, †A positive ARIDOL test is complete in approximately 20 minutes, compared to an average of 44 minutes for a methacholine test. †A methacholine test requires additional equipment to administer and a designated testing room with ventilation. The most common adverse reactions (rate greater than or equal to 1%) were headache, pharyngolaryngeal pain, throat irritation, nausea, cough, rhinorrhea, dyspnea, chest discomfort, wheezing, and dizziness.

Axiron for Male Hypogonadism

Axiron (Testosterone) - Lilly - this replacement therapy for men whose testosterone levels are blow normal is administered as a topical spray applied once daily under the armpit. In a multi-center study over 80% of men with low testosterone levels using Axiron had normal levels after 120 days of therapy Halaven for late-stage breast cancer.

Benlysta for lupus

Benlysta (Belimumab) - Human Genome Sciences - This is only the 4th drug ever approved to treat systemic lupus erythematosus (SLE) and it is the first in over 35 years. Bemlysta, which must be injected into the vein, appears to act by reducing the number of abnormal b-lymphocytes in the blood. B-lymphocytes are involved in many inflammatory reactions including SLE. Although clinical studies demonstrated effectiveness in reducing disease activity, it appears not to be effective or of limited effectiveness in African-/American patients. The most common side effects include: nausea, diarrhea, and fever.

Brilinta as blood-thinning agent for coronary artery disease

Brilinta (Ticagrelor) - Astra-Zeneca - this newly approved drug given by mouth is indicated for the prevention of cardiovascular death and heart attacks in patient with acute coronary artery syndromes. Like other in its class Brilinta is a platelet aggregation inhibitor acting by blocking platelet ADP receptors. However, Brilinta has a binding site different from ADP and the blockage is reversible. In clinical trials, Brilinta was more effective than Plavix in preventing heart attacks and death, but that advantage was seen with aspirin maintenance doses of 75 to 100 milligrams once daily," Brilinta is less effective if patients take more than 100 milligrams a day of aspirin. The so- called "baby aspirin" contains 81 milligrams of aspirin. The most common side effects are: bleeding and difficulty in breathing.

Bromday for pain following cataract surgery

Bromday (Bromfenac) - ISTA -Bromday has been approved for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. It is instilled once daily and advantage over other similar preparations currently available to treat the same condition.

Caprelsa for medullary thyroid cancer

Caprelsa (Vandetanib) - Astra-Zeneca - This newly approved drug is indicated for the treatment unresectable locally advanced or metastatic medullary thyroid carcinoma. It acts by interfering with the vascular endothelial growth factor (VEGF) receptor 2 (KDR/Flk-1) kinase inhibitor. This slows down the rapid turnover of malignant thyroid cells. In one clinical study an improvement in progession-free survival (PFS) was observed for patients receiving Caprelsa. The most common (≥ 20%) grade 1-4 adverse reactions included diarrhea/colitis, rash, dermatitis acneiform, nausea, hypertension, headache, fatigue, decreased appetite, and abdominal pain. Most common (≥ 5%) grade 3-4 adverse reactions were diarrhea/colitis, hypertension and hypertensive crisis, QT prolongation, fatigue, and rash. Adverse reactions resulting in death in patients receiving vandetanib (n=5) were respiratory failure, respiratory arrest, aspiration pneumonia, cardiac failure with arrhythmia, and sepsis.

Complera for HIV infections

Complera (Gilead) - this new medication is a combination of the nucleoside reverse transcriptase inhibitors Emtriva (Emtricitabine) and Viread (Tenofovir) and the non-nucleoside reverse transcriptase inhibitor Edurant (Rilpiravine) in a single dose taken once daily. This combination has been approved as a first-line treatment for HIV infections. The once daily dose schedule should help improve patient compliance,a problem when multiple drugs with different does schedules are prescribed for HIV infections. The most significant side effects are: lactic acidosis and severe liver damage.

Daliresp for COPD

Daliresp (Roflumilast) - Forest - this is a new treatment for the treatment of symptoms of chronic obstructive pulmonary disease (COPD). This drug is from a new class for COPD treatment, an inhibitor of an enzyme called phosphodiesterase type 4 (PDE-4). Side effects include: diarrhea 9.5%, weight decrease 7.5% Nausea 4.7% Headache 4.4%, and back pain 3.2% .

Dificid for C. difficile-associated diarrhea

Dificid (Fidaxomicin) - Optimer Pharmaceuticals - Dificid is a significant addition to the medications available to treat the diarrhea associated with Clostridium difficile infections. These infections, usually resulting from the previous treatment with antibiotics which unbalance the flora in the gastrointestinal tract, are frequently hard t treat especially in older patients with compromised immune systems. The response to Dificid was similar to that of oral vancomycin. Side effects are mld and consist of nausea, abdominal pain, occasional gastrointestinal bleeding, and low white blood cell counts.

Edarbi for hypertension

Edarbi (Azilsartan medoxomil) - Takeda - this newly approved drug is indicated for the treatment of hypertension. Edarbi is an angiotensin II receptor blocker (ARB) that lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone. Adverse reactions reported by patients taking Edarbi in clinical trials were similar to those reported by those taking an inactive drug (placebo). Edarbi has a boxed warning that says the use of the drug should be avoided in pregnant women because use of the drug during the second or third trimester can cause injury and even death in the developing fetus. If a woman becomes pregnant while using the drug, it should be discontinued as soon as possible.

Edurant for HIV-1 Infections

Edurantt (Rilpivirine) - Tibotec Therapeutics - Rilpivirine, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV 1) infection in antiretroviral treatment naïve adult patients (patients who have never taken HIV therapies, and are starting HIV therapy for the first time. The Phase 3 trials compared rilpivirine to efavirenz in antiretroviral-naïve HIV-1 infected subjects with HIV-1 RNA ≥ 5000 copies/mL and no NNRTI resistance. Overall, the proportion of subjects with HIV RNA < 50 copies/mL was 83% for rilpivirine based regimen compared to 80% for efavirenz based regimen. The predicted difference (95% CI) of response rates is 2.0 (-2.1; 6.1). The overall virologic failure rate was 13% for the rilpivirine compared to 9% for the efavirenz. The proportion of patients who discontinued study due to an adverse event or death was 2% for rilpivirine and 7% for efavirenz. The most common adverse drug reactions to rilpivirine (incidence > 2%) of at least moderate to severe intensity (≥ Grade 2) were depression, insomnia, headache and rash. The most common ADRs leading to discontinuation were psychiatric disorders: 10 (1%) subjects in the rilpivirine arm and 15 (2%) subjects in the efavirenz arm.

Egrifta for HIV-associated lipodystrophy

Egrifta (Tesamorelin) - Serono - Egrifta has been approved for the treatment of the deposit of excess fat which develops in patients with HIV infections. Egrifta is a synthetic growth hormone release factor that acts on pituitary cells in the brain to stimulate growth hormone production, which has been shown to reduce the formation of Visceral Abdominal Tissue in people with lipodystrophy. In a placebo-controlled study of over 500 patients with VAT, those receiving Egrifta by daily injections experienced greater reductions in abdominal fat as measured by C-scan as well as an improved body image. Side effects: joint pain, skin redness, stomach and muscle pain.

Elyea for macular degeneration

Elyea (Afilbercept) - Regeneron - This is only the second drug been approved for the treatment of neovascular (wet) age-related macular degeneration of the eye., the first being Lucentis. This drug, given by injection, is a blocker of vascular endothelial growth factor (VEGF) which slows the formation of new vessels in the affected part of the macula in the eye. In clinical trials, the most common side effects were bleeding in the white part of the eye at the site of injection, eye pain, cataracts, detachment of the gel part of the eye (vitreous) from the retina, floating spots in the vision, and increased pressure within the eye.

Ferriprox for transfusion produced iron oveload

Ferriprox (Deferiprone) - Apopharma - Ferriprox (deferiprone) has been approved by the FDA to treat patients with iron overload due to blood transfusions in patients with thalassemia, a genetic blood disorder that causes anemia, who had an inadequate response to prior chelation therapy. Patients with thalassemia have excess iron in the body from the frequent blood transfusions (transfusional iron overload), a condition that is serious and can be fatal. These patients also have a risk of developing liver disease, diabetes, arthritis, heart failure or an abnormal heart rhythm. Ferriprox effectiveness is based on data from twelve clinical studies in 236 patients. Patients participating in the study did not respond to prior iron chelation therapy. Ferriprox was considered a successful treatment for patients who experienced at least a 20 percent decrease in serum ferritin, a protein that stores iron in the body for later use. Half of the patients in the study experienced at least a 20 percent decrease in ferritin levels. The most common side effects are: included nausea, vomiting, abdominal and joint pain, urine discoloration (chromaturia), a decrease in the number of white blood cells (neutropenia), and an increase in the level of a liver enzyme that may be indicative of tissue or liver damage at unsafe amounts. The most serious side effect seen in about two percent of patients treated with Ferriprox was the development of agranulocytosis, a serious and potentially life-threatening reduction in the number of granulocytes (a type of white blood cell that fights infection).

Firazyr for hereditary angioedema

Firazyr (Icatibant) - Shire - this is an important new drug indicated for the treatment of acute attacks of hereditary angioedema (HAE). HAE is due to the failure of a substance called C1 inhibitor. This inhibitor is critical in the regulation of certain aspects of blood clotting and the immune system. An episode of HAE results in swelling of the hands and feet, intestinal tract, and windpipe all of which can result in significant disability. Airway swelling can result in suffocation while swelling of the abdominal tract can produce significant abdominal pain and vomiting. Relief of symptoms usually occur by two hours after administration. The most common side effects are comparatively mild and include: fever, increased liver enzymes, dizziness and a rash.

Gablofen for spasticity

Gablofen (Baclofen) - CNS Therapeutics - this is an improved version of the previously approved Lioresal. It is used to reduce the severe spasticity associated with multiple sclerosis. This new form in prefilled syringes is easier for both pharmacists and nurses to prepare for the programmable drug pumps used to administer this medication intrathecally.

Gadavist for imaging of central nervous system

Gadavist (Gadobutrol) - Bayer - this new diagnostic agent has been approved for use in patients undergoing magnetic resonance imaging (MRI). It improves the ability of an MRI to locate lesions in the central nervous system. Gadolinium-based contrast agents may produce nephrogenic systemic fibrosis, a disease producing pain and thickening of the skin and potentially, fibrosis of internal organs.

Gralise for post-herpetic neuralgia

Gralise (Gabapentin) - Depomed - (Gralise, Depomed and Abbott Products) has been approved by the FDA for once-daily treatment of post-herpetic neuralgia (PHN). “In order to dose patients up to 1,800 mg a day [over 2 weeks], patients may require 3 to 6 tablets as a final dose. Gabapentin is available commercially under other trade names. The only major advantage to this formulation over previously available gabapentin formulations is the potential for better patient adherence Gralise was approved on the basis of 2 trials involving 359 patients treated with Gralise and 364 treated with placebo. Efficacy was based on the second phase 3 trial, a randomized, double-blind, placebo- controlled study of 452 PHN patients. In this trial, Gralise achieved a statistically significant reduction in average daily pain score compared to placebo. The most common reason for discontinuation due to adverse reactions was dizziness (10.9%). Of Gralise-treated patients who experienced adverse reactions, the majority of those adverse reactions were either “mild” or “moderate.”

Halaven for late-stage breast cancer

Halaven (Eribulin) - Eisai - Halaven is indicated for the treatment of metastatic breast cancer in patients who have had at least two prior chemotherapy treatments for late-stage disease. Derived from a sea sponge, Halaven acts by inhibiting the formation of microtubules which are required for cell growth. In late stage breast cancer patients, the overall survival for patients receiving Halaven was 13.1 months and for those patients not receiving Halaven 10.6 months. The most common side effects were: anemia,hair loss, tiredness, peripheral neuropathy, and a decrease in white blood cells.

Horizant for Restless Legs Syndrome

Horizant (Gabapentin encarbil) - Glaxo - this medication has been approved for the treatment of moderate to severe primary Restless Legs Syndrome (RLS). Patients with RLS experience the urge to move caused by unpleasant sensations in the legs. Although other formulations of gabapentin are available they cannot be used interchangeably with Horizant due to differing rates of absorption and metabolism. This medication may produce significant driving impairment. The most significant side effects are sleepiness, sedation and dizziness.

laViv for facial smile lines

laViv (Azficel-T) - Fibrocell - this new product employs a new technique of injecting a patients own fibroblasts into the area where the smile lines (severe nasolabial fold wrinkles) are located. The technique involves harvesting a relatively small number of fibroblasts from a prospective patient and subsequently growing more fibroblasts in vitro. Once a sufficient amount has been grown, the fibroblasts are injected into the wrinkles of the donor patient. Clinical trials demonstrated improved appearance for up to six months following a series of 3 injections five weeks apart. Side effects include: injection site redness, bruising, pain, nodules, and pruritus (itching).

Incivek for Hepititis C

Incivek (Telaprevir) - Vertex Pharma -this is a new addition to the drugs approved for the treatment of adults with hepatitis C who have not responded to other therapies. Incivek is approved for use with interferon therapy made up of peginterferon alfa and ribavirin. The safety and effectiveness of Incivek was evaluated in three clinical trials with about 2,250 patients who were previously untreated, or who had received prior therapy. In previously untreated patients, 79 percent of those receiving Incivek experienced a sustained virologic response (i.e. the infection was no longer detected in the blood 24 weeks after stopping treatment) compared to standard treatment alone. The most common side effects in patients also receiving peginterferon alfa and ribavirin include rash, low red blood cell count (anemia), nausea, fatigue, headache, diarrhea, itching (pruritus), and anal or rectal irritation and pain.

Jakafi for myelofibrosis

Jakafi (Ruxolitinib) - Insight Pharmaceuticals - This newly approval orally administered drug has been approved for the treatment of intermediate or high-risk myelofibrosis. It is the first approved drug in a class of medicines that function by inhibiting the effect of one or more of the Janus kinase family of enzymes (JAK1, JAK2, JAK3, TYK2), interfering with the JAK-STAT signaling pathway. This pathway transmits information from chemical signals outside the cell, through the cell membrane, and into gene promoters on the DNA in the cell nucleus, which causes DNA transcription and activity in the cell. As measured by spleen volume, Jakafi produced a 35% or greater reduction in size. Side effects include moderate thrombocytopenia and anemia. Other less significant side effects included: brusing, dizziness, and headache.

 

Kapvay for attention-deficit-hyperactivity disorder

Kapvay (Clonidine) - Shionogi - Kapvay is available as extended-release tablets and has been approved for the treatment of attention-deficit-hyperactivity disorder (ADHD). Clonidine, previously used as an antihypertensive, appears to act in the pre-frontal cortex of the brain, a part involved in attention. When studied in children and adolescents (6-17 years), Kapvay resulted in significant improvements in the symptoms of ADHD, inattention, hyperactivity, and impulsivity. Side effects include: drowsiness, fatigue, increase in respiratory tract infections, insomnia, nasal congestion, and ear pain.

Latuda for schizophrenia

Latuda (Lurasidone) - Sunovion - Latuda is indicated for the treatment of adults with schizophrenia. It belongs to a class of atypical antipsychotics. This class of antipsychotics carry a strong warning that they are not to be used to treat dementia-related psychosis. The most common adverse effects are: drowsiness, restlessness, urge to move, tremors, and muscle stiffness.

Lazanda nasal spray for cancer pain

Lazanda (Fentanyl) - ARCHIMEDES PHARMA - this fentanyl nasal spray has been approved for the treatment of moderate to severe pain in adult patients with cancer. This is a new dose form as prior to Lazanda, fentanyl was given either by injection, by patches applied to the skin or by lozenges. least 60 mg of oral morphine daily.

Makena for premature delivery

Makena (Hydroxyprogesterone) - TherRx - this drug has been approved for the prevention of premature deliveries. It is indicated for a subset of pregnant women who are carrying only one baby and who have given birth pevioudly to a prermature baby. In a study of 463 pregancies of women who had delivered prematurely previously, 37% delivered before 37 weeks compared with 55% of those taking a placebo.

Nuedexta for involuntary laughing and crying

Nuedexta (Quinidine and Dextromethorphan) - Avanir - this is an unusual combination of an antiarrhythmic drug with a cough suppressant. Given by mouth, it has been approved for the reduction in episodes of involuntary episodes of laughing and crying, a complication of a number of neurologic disorders including Alzheimerís dementia. It is proposed to exert it action on the brain neurotransmitter, glutamate. Side effects include possible changes in heart rhythm, diarrhea, dizziness, cough, vomiting, weakness, swelling of feet and ankles, urinary tract infection, flu, elevated liver enzymes, and flatulence.

Nulojix for kidney transplants

Nulojix (Belatecept) - Bristol-Myers - this has been approved for the prevention of an acute rejection following the surgical implantation of a donated kidney. Pharmacolgically,it is a selective T-cell costimulation blocker. Activation of T- cells is part of the process leading to rejection of a transplanted kidney. It carries a warning that patients receiving Nulojix may develop post-transplant lymphoproliferative disorder, a type of cancer where white blood cells grow out of control.

Ofirmev for mild to moderate pain

Ofirmev (Acetaminophen) - Cadence - this is the first formulation of acetaminophen which can be given intraveneously (I.V.) It has been approved both for the treatment of pain and fever. When used with an intravenous narcotic it was able to significantly reduce the narcotic dose by 33%. Is was approved for use in adults and children over 2 years of age.

Onfi for seizures associated with the Lennox-Gastaut syndrome

Onfi (Clobazam) - Lundbeck - this new addition to the anticonvulsant mediations has specifically been approved for the treatment of the seizures associated with the Lennox-Gastaut syndrome. This syndrome is responsible for 1-4% of all childhood epilepsies. Clinical studies demonstrated a significant reduction in Seizures compared with placebo. No head-to-head comparisons were made with other available anticonvulsalts. Adverse effects include; sedation, droolingPEGinterferon alfa)-Schering- aggression, problems with coordination, upper respiratory tract infections.

Potiga for adult epilepsy

Potiga (Ezogabine) - GSK - this new chemical entity has been approved for the tratment of partial seizures Which can progress to a major grand mal seizure. The mechanism of action may be to open the potassium channels of affected brain cells thus making it more difficult for them to be spontaneously activated which would potentially produce a seizure. The most common side effects are: dizziness,fatigue,problems with coordination, memory imairment and double-vision. Importantly, it can also cause urinary retention particularly in the first 6 months of therapy.

RECTIV for anal fissures

Rectiv (Nitroglycerin) - Prostrakan - this 0.4% ointment the first medication approved for the treatment of moderate to severe pain associated with chronic anal fissures. It acts by relaxing the internal sphincter whose hypertonicity is a predisposing factor in the formation of anal fissures. It is inserted rectally every 12 hours uThe most common side effects include headache and dizziness.

Sorilux for psoriasis

Sorilux (Calcipotriene) - Stiefel - Sorilux applied topically has been approved for the treatment of mild to moderate plaque psoriasis in patients 18 years of age and older. It is a vitamin D3 analog however its mechanism in treating psoriasis is unknown. When compared with a placebo, 27% of patients treated with Sorilux showed improvement compared with 16% using the vehicle alone. Those with the milder form of the disease may respond better than those with the moderate form. Side effects were local and consisted of irritation, redness and itching of the treated areas.

Sylatron for melanoma

Sylatron (PRGinterferon alfa-2B) - Schering - this has been approved by the FDA to treat melanoma with nodal involvement after surgical resection. In a clinical trial, patients who took the drug delayed cancer recurrence by about 9 additional months compared with patients who did not take the drug. Significant side effects include: fatigue,fever,chills, increase in liver enzymes, headache, taste disorders, dizziness, anorexia, nausea, depression, rashes,and alopecia.

Teflaro for bacterial infactions

Teflaro (Ceftaroline) - Forest - this newly approved injection has been approved for the treatment of adults with community acquired bacterial pneumonia and acute bacterial skin infections, inclouding methicillin-resistant Staphlococcus aureus. It belongs to the cephalosporin class of antibiotics. The most common side effects included:diarrhea, nausea and rashes.

Tradjenta for Type 2 diabetes

Tradjenta (linagliptin) - Boheringer Ingelheim - this is another addition to the drugs used to treat elevated blood glucose levels found in older patients (Type 2 diabetes or maturity onset diabetes). It acts by elevating the level of hormones which stimulate the release of insulin following a meal. This is accomplished by blocking the enzyme dipeptidyl peptidase. Side effects are relatively mild and include: sore throat, runny nose, muscle pain, headache and upper respiratory tract infections.

Victrelis for Hepatitis C

Victrelis (Boceprevir) - Merck - The U.S. Food and Drug Administration approved Victrelis (boceprevir) to treat certain adults with chronic hepatitis C. Victrelis is used for patients who still have some liver function, and who either have not been previously treated with drug therapy for their hepatitis C or who have failed such treatment. Victrelis is approved for use in combination with peginterferon alfa and ribavirin. The safety and effectiveness of Victrelis was evaluated in two phase 3 clinical trials with 1,500 adult patients. In both trials, twothirds of patients receiving Victrelis in combination with pegylated interferon and ribavirin experienced a significantly increased sustained virologic response (i.e., the hepatitis C virus was no longer detected in the blood 24 weeks after stopping treatment), compared to pegylated interferon and ribavirin alone, the current standard of care. The most commonly reported side effects in patients receiving Victrelis in combination with pegylated interferon and ribavirin include fatigue, low red blood cell count (anemia), nausea, headache and taste distortion (dysgeusia).

Viibryd for major depression

Viibryd (Vilazodone) - PGxHealth - This new antidepressant has been approved for the treatment of major depressive disorder in adults. It differs from the many other antidepressants currently on the market in its proposed mechanism of action. In addition to being a selective serotonin reuptake inhibitor it also is a 5HT1A receptor partial agonist. Side effects include: diarrhea, nausea, vomiting and insomnia. In males, other side effects were: decreased libido, abnormal ejaculation, and delayed ejaculation.

Xalkori for late-stage (locally advanced or metastatic), non-small cell lung cancers

Xalkori (Crizotinib) - Pfizer - this new drug has being approved for for late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC). To determine potential effectiveness with a companion diagnostic test is also provided that will determine if a patient has the abnormal ALK gene, a first-of-a-kind genetic test called the Vysis ALK Break Apart FISH Probe Kit. This ALK gene abnormality causes cancer development and growth. About 1 percent to 7 percent of those with NSCLC have the ALK gene abnormality. Patients with this form of lung cancer are typically non-smokers. Xalkori works by blocking certain proteins called kinases, including the protein produced by the abnormal ALK gene. Xalkori’s safety and effectiveness were established in two multi-center, single-arm studies in patients with late-stage ALK-positive NSCLC. Most patients in the studies had received prior chemotherapy. In one study, the objective response rate was 50 percent with a median response duration of 42 weeks. In another, the objective response rate was 61 percent with a median response duration of 48 weeks. The most common side effects reported included vision disorders, nausea, diarrhea, vomiting, swelling (edema), and constipation. Vision disorders included visual impairment, flashes of light, blurred vision, floaters, double vision, sensitivity to light, and visual field defects. Xalkori use has also been associated with inflammation of the lung tissue (pneumonitis), which can be life- threatening

Xarelto for prevention of venous clots associated with knee or hip-replacement surgery

Xarelto (Rivaroxaban) - J&J - this new anticoagulant is given by mouth and has been approved for the prevention of venous thromboembolism (VTE) in patients who have knee and hip-replacement surgery. Xarelto acts by inhibiting both free Factors Xa and Factor Xa. Inhibition of Factor Xa interrupts the pathways of the blood coagulation cascade, inhibiting both thrombin formation and development of thrombi. It has a boxed warning that epidupatients who receive neuraxial anesthesia or undergo spinal puncture.

Xgeva for osteolytic cancer-caused bone metastasis

Xgeva (Denosumab) - Amgen - many cancers when they spread will invade the bone. This will frequently result in destruction of bone with resultant increase in fractures and bone pain. Previously marketed for postmenopausal osteoporosis (Prolia) Xgeva is given monthly by injection. Xgeva binds to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. Xgeva prevents RANKL from activating its receptor on the surface of osteoclasts thus preventing the breakdown of bone. Side effects include low blood calcium, osteonecrosis of the jaw bone preceded by jaw pain, swelling and numbness.

Yervoy for late stage melanoma

Yervoy (Ipilimumab) - Bristol-Myers - This is an important addition to the chemotherapy available for metastatic melanoma. As a monoclonal antibody, Yervoy blocks a molecule known as cytotoxic T-lymphocyte CTLA-4. Blocking this molecule apparently increases the ability of the body to recognize malignant cells and to slow their growth. Clinical studies comparing Vervoy to an immune therapy treatment showed that patients receiving Yervoy lived for an average of 10 months compared with those receiving the vaccine alone who lived for 6.5 months. Side effects may be significant including autoimmune reactions which can be life-threatening, fatigue, inflammation of the intestines (colitis), diarrhea, and problems with the endocrine system.

Zelboraf for metastatic multiple myloma

Zelboraf (Vemurafenib) - Roche (genentech) - this is a significant addition to the chemotherapeutic agents available for the treatment of multiple myeloma. It specifically targets those patient with multiple myeloma whose tumors express a gene mutation called BRAF V600E. This genetic mutation is found in about 50% of patients with multiple myeloma. In a clinical trial of 675-BRAF-positive patients, those treated with Zelboraf progression-free survival was prolonged from 1.6 months on standard therapy to 5.3 months on Zelboraf. Side effects include: non-melanoma skin cancer (squamous cell) which occurred in 26% of patients, joint pain,rash, hair loss, fatigue and sensitivity to sunlight. Note: Genentech will not allow the purchase of Zelboraf for export to any patient outside of the United States.

Zytiga for late stage prostate cancer

Zytiga (Abiraterone) - Centocor Ortho Biotech - Zytiga is indicated along with prednisone in the treatment of men with late-stage (metastatic) castration-resistant prostate cancer who have been previously treated with docetaxel. It acts by inhibiting the action of cytochrome CYP17A1, an enzyme involved in the production of testosterone (most prostate cancer growth is testosterone-stimulated). In clinical trials median survival was increased from 10.9 months to 14.8 months with Zytiga. Side effects are: joint swelling and discomfort, fluid retention, muscle discomfort, hot flashes, urinary frequency, indigestion and upper respiratory react infections.