FDA Approves Melanoma Drug

The FDA today approved a first-of-its-kind medication to treat melanoma.

The drug targets a gene mutation that's present in about half of melanomas, the deadliest form of skin cancer. "Zelboraf is a huge step forward in the fight against metastatic melanoma and the advancement of treatment for the deadliest form of skin cancer," Dr. Anna Pavlick, director of the NYU Melanoma Program at the NYU Cancer Institute, New York City, said in a university statement. She took part in phase II and III trials of the drug and is an advisor to Zelboraf's maker, Genentech. "The approval of Zelboraf will make a significant impact on the survival and outcomes of advanced melanoma patients," Pavlick added. "Patients taking the drug Zelboraf were 63 percent less likely to die from advanced melanoma than patients given standard chemotherapy alone," she noted.

The drug should be available within weeks. The side effects listed in the above-linked article appear to be rather significant.

FDA Approves New HIV Med

Yesterday the FDA approved the second all-in-one daily combination pill for the treatment of HIV infection. The first such medication, Atripla, has been on the market for several years.

Complera, a complete single-tablet regimen containing Janssen Therapeutics’ Edurant (rilpivirine) and Gilead Sciences’ Viread (tenofovir) and Emtriva (emtricitabine), was approved August 10 by the U.S. Food and Drug Administration (FDA), according to an announcement by Gilead. Complera, the second all-in-one fixed-dose combination tablet for people living with HIV, is approved for those starting antiretroviral (ARV) therapy for the first time.

The new combination pill is not yet available in Europe.