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A Good Year: FDA Approved Nine New Cancer Drugs in 2014

, by NCI Staff

In 2014, the Food and Drug Administration (FDA) approved 41 drugs that had not been approved previously for any indication, the most in nearly 20 years. Of these 41 novel drugs, 9 were approved for the treatment of cancer or cancer-related conditions.

The development of new therapeutic biologics, in particular, is a trend that continues to drive cancer drug development and approval by the FDA, according to Henry Francis, M.D., of the FDA’s Center for Drug Evaluation and Research.

The FDA’s acceleration of the review process for cancer drug approval is another important factor, added Dr. Francis. Because treatment options are limited for many cancer patients with advanced disease, the FDA has implemented expedited approval procedures for cancer drugs. In some respects, the approach resembles how the agency evaluated and approved early AIDS drugs, he noted.

The following are the new drugs for cancer or cancer-related conditions approved last year by the FDA:

In February 2014, the FDA also gave full approval for ibrutinib (Imbruvica) to treat CLL. It was initially given accelerated approval in 2013 for patients with mantle cell lymphoma, a rare and aggressive type of blood cancer.

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