New drug and biological product approvals, 2011

A total of 37 new molecular entities, vaccines, and blood products won FDA marketing approval last year, compared with 29 in the previous year. Highlights of several of the approved medications appear below. A full list of new products and their indications appears on page 181. 2011 saw the approval of nine cancer treatments, including two—Pfizer’s kinase inhibitor crizotinib and Genentech’s vemurafenib—that FDA officials heralded as groundbreaking developments in personalized medicine. Vemurafenib was approved in August for the treatment of certain melanomas that have a specific mutation in the gene encoding BRAF, a protein kinase. Crizotinib was approved later that month for the treatment of non-small cell lung carcinoma in people who express an abnormal anaplastic lymphoma kinase gene. Both drugs were approved along with a diagnostic genetic test to identify patients whose tumor cells are likely to respond to the therapy. Two injectable medications for patients with melanoma were approved during the first half of the year— ipilimumab, by Bristol-Myers Squibb, and peginterferon alfa-2b for s.c. injection, by Merck.