FDA actions

FDA actions

The FDA has approved a new fixed-dose combination pill for HIV-infected patients. Emticitabibine/rilpirivine/tenfovir DF is approved as a once-a-day pill for treatment of HIV-1 infection in treatment-naïve patients. This is the second triple combination anti-HIV agent approved and differs from the previous agent (Atripla) in that it contains the NNRTI rilpirivine rather than efavirenz. The new combination will be marketed as Complera.

The FDA has approved brentuximab vedotin to treat Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma. The drug is approved for HL patients who have progressed after autologous stem cell transplant or after prior chemotherapy regimens and cannot receive a transplant. This represents the first the drug to treat HL since 1977. Brentuximab will be marketed as Adcetris.

The FDA has approved vemurafenib for the treatment of metastatic and unresectable melanoma, specifically in patients whose tumors have the BRAF V600E mutation. The approval was accompanied by a companion diagnostic test that will determine if a patient's melanoma cells have that mutation (about half of the patients with late stage melanomas). Only patients with the BRAF V600E mutation will respond to the drug since it targets the mutated protein that regulates cell growth. Vemurafenib is marketed by Genentech as Zelboraf.