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The agency has approved a new treatment for a certain type of prostate cancer using novel clinical trial endpoint.
On Feb. 14, 2018, FDA approved Erleada (apalutamide) for the treatment of patients with non-metastatic castration-resistant prostate cancer, a cancer that has not spread but that continues to grow despite treatment with hormone therapy. According to the agency, this is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer.
The drug works by blocking the effect of androgens, a type of hormone, on the tumor. These androgens, such as testosterone, can promote tumor growth. FDA granted the application priority review and granted drug approval to Janssen Pharmaceutical Companies of Johnson & Johnson based on Phase III data, according to Janssen.
“The FDA evaluates a variety of methods that measure a drug’s effect, called endpoints, in the approval of oncology drugs. This approval is the first to use the endpoint of metastasis-free survival, measuring the length of time that tumors did not spread to other parts of the body or that death occurred after starting treatment,” said Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, in an agency press release. “In the trial supporting approval, Erleada had a robust effect on this endpoint. This demonstrates the agency’s commitment to using novel endpoints to expedite important therapies to the American public."