The U.S. Food and Drug Administration (FDA) gave the green light to 35 new medicines in 2011, including seven new innovative drugs for cancer, two drugs for hepatitis C and a new drug for lupus, the first new pharmaceutical for the disease in 50 years.
It's the highest number of approvals over the last decade, with the exception of 2009 when 37 were approved. Of the 35 approvals, the FDA believes 17 are especially notable for their potential to aid patients. These drugs were designated a priority and were given expedited review.
Eight of the priority drugs were approved in six months or less from the time of submission to approval. "I want to underscore that we approved a set of drugs that are truly medically important, and in fact did so in a way that made these drugs available to Americans before other places around the world," said FDA commissioner Margaret Hamburg, MD, in a statement to the media.
- Adcetris (brentuximab vedotin) to treat Hodgkin's lymphoma and systemic anaplastic large cell lymphoma, Seattle Genetics Inc.
- Caprelsa (vandetanib) to treat thyroid cancer, AstraZeneca
- Halaven (eribulin mesylate) for metastatic breast cancer, Eisai Inc.
- Xalkori (crizotinib) and companion genetic test for late-stage lung cancer, Pfizer
- Yervoy (ipilimumab) for late-stage melanoma, Bristol-Myers Squibb Co.
- Zelboraf (vemurafenib) and companion genetic test for late-stage melanoma, Roche
- Zytiga (albiraterone acetate) for late-stage prostate cancer, Janssen Biotech, Inc.
Some of the new cancer drugs carry a very heavy price tag. For example, Adcetris, Xalkori, Yervoy and Zelboraf all cost about $100,000 for a year's worth of treatment.
Hepatitis C Drugs
- Incivek (teleprevir) for chronic hepatitis C, Vertex Pharmaceuticals
- Victrelis (boceprevir) to treat chronic Hepatitis C, Merck
Victrelis, the first drug approved in its class, offers an improved chance of cure for some patients with the hepatitis C infection compared to previously available therapy, according to the FDA. Both Both