Monthly News Round Up - November 2012
Cometriq Approved for Rare Form of Thyroid Cancer
Cometriq (cabozantinib) is a kinase inhibitor approved for the treatment of patients with progressive, medullary thyroid cancer that has spread to other parts of the body. Cometriq received priority review at the U.S. Food and Drug Administration (FDA) and is a designated as an orphan drug. In a clinical study of 330 patients, the group that received Cometriq lived roughly 11 months without tumor growth compared with four months in the placebo group. Reductions in tumor size lasting an average of 15 months were also seen in the Cometriq group; however, treatment with Cometriq did not extend patients’ lives. Caprelsa (vandetanib) was also approved in April of 2011 for treatment of this rare disease.
Flucelvax Approved: Production Utilizes Cell-Culture Technology
Getting vaccinated each year remains one of the best ways to prevent seasonal influenza. Previously, fertilized chicken eggs have been used to grow the virus strains used in the flu vaccine. The U.S. Food and Drug Administration (FDA) has now approved Flucelvax for adults, the first seasonal influenza vaccine licensed in the U.S. that is produced using cultured animal cells of mammalian origin instead of fertilized chicken eggs. Advantages of cell-culture technology include the ability to rapidly produce flu vaccine. Cell-culture technology is successfully used for other vaccines, including H1N1, as well as vaccines for polio, rubella and hepatitis A.
Pfizer’s Xeljanz Approved for Difficult-to-Treat Rheumatoid Arthritis
The U.S. Food and Drug Administration (FDA) has approved Xeljanz (tofacitinib), a twice a day pill, to treat adults with moderate-to-severe rheumatoid arthritis. Xeljanz is targeted to patients who have had unsuccessful treatment or intolerable side effects with methotrexate. Xeljanz is a janus kinase inhibitor that blocks an enzyme responsible for inflammation and pain of rheumatoid arthritis. Serious side effects, which resulted in a Boxed Warning for the Xeljanz label, include serious infections, tuberculosis, cancers and lymphoma. The most common side effects in studies were upper respiratory tract infections, headache, diarrhea, and nasal passage and upper pharynx inflammation.
Xarelto Approved for Deep Vein Thrombosis and Pulmonary Embolism
Xarelto (rivaroxaban) is an oral pill in the class of drugs called factor Xa inhibitors that reduces the ability of the blood to clot. The U.S. Food and Drug Administration (FDA) has approved Xarelto for treatment of deep vein thrombosis (DVT) or pulmonary embolism. DVT occurs when a blood clot forms in a deep vein in the body - if it travels to an artery in the lung, it can result in a potentially fatal lung embolism. Xarelto was previously approved for prevention of blood clots after knee or hip replacements and to reduce the risk of stroke in nonvalvular atrial fibrillation, an abnormal heart rhythm.
Promacta Approved for Treatment of Thrombocytopenia in HCV
Chronic hepatitis C viral infection (HCV) is the most common blood-borne infection in the U.S. The U.S. Food and Drug Administration (FDA) has approved Promacta (eltrombopag) for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy. Promacta in combination with interferon-based therapy used in HCV can improve a patient's chance of achieving a sustained virologic response or viral cure. The approval of Promacta is based on results from the ENABLE 1 and 2 clinical trials in which over 1,500 patients also received either peginterferon alfa-2a (Pegasys) or peginterferon alfa-2b (Pegintron) plus ribavirin.
Posted: November 2012