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Monthly Roundup - February 2012

Inlyta Approved For Advanced Renal Cell Carcinoma

Inlyta (axitinib) is an oral kinase inhibitor approved for the treatment of advanced renal cell carcinoma (kidney cancer) in adults after failure of one prior therapy. A single, randomized, open-label clinical trial (n=723) demonstrated that Inlyta resulted in a median progression-free survival of 6.7 months compared to 4.7 months with Nexavar (sorafenib), also a renal cell cancer drug. Common side effects include diarrhea, high blood pressure, and fatigue. High blood pressure should be well controlled in all patients prior to treatment. Avoid strong CYP3A4/5 inhibitors with Inlyta. Other approved agents for renal cell carcinoma include sunitinib, temsirolimus, everolimus, bevacizumab, and pazopanib.

FDA Approves Kalydeco For Rare Form of Cystic Fibrosis

Cystic fibrosis (CF) is an inherited disease that results in faulty transport of salts and fluids from the lungs and digestive tract that can lead to serious infections. Kalydeco (ivacaftor) has been FDA-approved for patients six years and older that have the G551D mutation on the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene. In the U.S., about 1,200 out of 30,000 CF patients have this faulty G551D mutation. Kalydeco improves the transport of salts and fluids in the body, reducing mucous build-up and leading to improved lung function and weight gain. Kalydeco improved lung function (FEV1) significantly in two 48-week, placebo-controlled studies. Kalydeco treatment for one patient will cost about $300,000 per year.

Bydureon: First Once-A-Week Treatment for Type 2 Diabetes Authorized

Amylin Pharmaceuticals has received FDA-approval of Bydureon (exenatide extended-release for injectable suspension), a once a week, 2 mg injection used in conjunction with diet and exercise to improve glycemic control in type 2 diabetics. Exenatide is the same active ingredient in Byetta, which is given twice daily. The 24-week DURATION-5 clinical trial demonstrated that Bydureon statistically reduced A1C, a measure of blood sugar control, by 1.6 percentage points compared to a 0.9 percentage point reduction with Byetta. Nausea was the most frequently reported adverse event. A boxed warning of the occurrence of thyroid C-cell tumors at clinically relevant doses in rats accompanies the Bydureon approval; however, it is not known if Bydureon causes medullary thyroid carcinoma (MTC) in humans.

Bio-T-Gel Approved: Testosterone Replacement Therapy For Men

Bio-T-Gel (testosterone gel) has been FDA-approved for the treatment of low testosterone levels, a condition that afflicts between 4 and 5 million men nationwide. The causative factors in low testosterone levels may be an inadequate production or a signaling disconnect between the brain and the testes. Hypogonadism typically occurs in men when testosterone levels fall below 300 nanograms/deciliter. Low testosterone not only results in reduced sexual desire, but also fatigue, decreased energy, and depressed mood. BioSante has licensed Bio-T-Gel to Teva Pharmaceuticals for all U.S. regulatory and marketing activities. BioSante is also developing LibiGel, a testerone gel product for low testosterone in women, but Phase III trial efficacy measures have not met statistical significance.

Erivedge Receives Priority Approval For Metastatic Skin Cancer

Basal cell carcinoma is the most common form of sun-induced skin cancer. But when the cancer is no longer treatable by surgery or radiation, or the disease has spread throughout the body, treatment options are limited. The U.S. Food and Drug Administration has approved Erivedge (vismodegib), the first hedgehog pathway inhibitor available for treatment of metastatic basal cell cancer. In Genentech trials, a partial response was seen in 30 percent of patients with metastatic disease, while a partial or complete response was seen in 43 percent of patients with locally advanced disease. The median duration of response was 7.6 months. Common side effects include muscle spasms, hair loss, altered taste and weight loss. Fetal defects or death may occur with Erivedge exposure in pregnancy.

Posted: February 2012