The FDA greenlighted 17 novel cancer agents in 2018, including one with a novel endpoint in a clinical trial and one through an expanded access program. The agency also approved five biosimilars to treat cancer or the side effects of treatment.

The FDA approved 59 new drugs in 2018—a record number. Of that total, 17 are novel cancer agents, two of which were greenlighted with nontraditional data, according to a report released by the agency's Center for Drug Evaluation and Research (CDER; available at

The document “emphasizes some of the many innovative ways we were able to evaluate safety and efficacy for these new therapies,” CDER Director Janet Woodcock, MD, writes in the introduction.

Take apalutamide (Erleada; Janssen), for example. This antiandrogen, used to treat nonmetastatic castration-resistant prostate cancer, is the first drug approved based on metastasis-free survival instead of a traditional clinical trial endpoint, such as overall survival or progression-free survival.

In addition, the FDA approved lutetium Lu 177 dotatate (Lutathera; Advanced Accelerator Applications), a radioactive drug for gastroenteropancreatic neuroendocrine tumors, a group of rare cancers with few treatments. The approval was based on safety and efficacy data from an expanded access program through which patients can receive experimental drugs when no approved therapy is available. “This use of data represents an innovative way to … approve a needed therapy,” the report explains.

Five biosimilars related to cancer treatment hit the market in 2018 as well, the highest annual tally to date. “As patents and exclusivity protections for biologics expire in the United States, we can expect many more biosimilars to be submitted for approval,” Woodcock writes. “More products on the market means greater competition that can lead to increased access to therapies and lower costs to patients.” –Suzanne Rose

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