New FDA Approvals

FDA recently approved these drugs:
• Pantheon's Zolinza (vorinostat) capsules were approved for treating cutaneous T-cell lymphoma (CTCL), a type of skin cancer, to be used when the disease persists, gets worse, or comes back during or after treatment with other medicines. Vorinostat was approved under the agency's Orphan Drug program that gives drug companies financial incentives to develop medications for diseases affecting fewer than 200,000 American patients yearly.

The drug's safety and effectiveness were assessed in two clinical trials with 107 CTCL patients who received vorinostat after their disease had recurred following other treatments. A positive response (improvements on a scale scoring skin lesions) occurred in 30% of patients receiving vorinostat, and lasted for an average of 168 days.

The most common serious adverse events were pulmonary embolism, dehydration, deep vein thrombosis, and anemia. The most common other adverse events were gastrointestinal symptoms, fatigue, chills, and taste disorders.

Although it has not been studied in pregnant women, results of animal studies suggest that the drug may cause fetal harm when administered during pregnancy.

• Merck's Januvia (sitagliptin phosphate) tablets were approved as the first diabetes treatment in a new class of drugs known as DPP-4 inhibitors that enhance a body's own ability to lower elevated blood sugar. FDA approved sitagliptin phosphate for use in addition to diet and exercise to improve blood sugar levels in patients with Type 2 diabetes, alone or in combination with two other commonly prescribed oral diabetes medications — metformin or a PPAR (peroxisome proliferator-activated receptor gamma) agonist, when either of the drugs, alone or along with diet and exercise, don't provide adequate sugar control.

• Sanofi-Aventis' Taxotere (docetaxel) injection concentrate was approved for use in combination with cisplatin and fluorouracil before radiotherapy for treating patients with inoperable, locally advanced squamous cell carcinoma of the head and neck.

• Novartis' Tyzeka (telbivudine) has been approved for treating adults with chronic hepatitis B. The agency said telbivudine is a new molecular entity. It is not a cure for hepatitis B. FDA said telbivudine was well tolerated and most reported adverse events were mild to moderate.