Drugs

Janssen’s Erleada Approved for Prostate Cancer

FDA has approved a Janssen Pharmaceutical NDA for Erleada (apalutamide) for treating patients with prostate cancer that has not spread, but that continues to grow despite treatment with hormone therapy (castration-resistant). An agency release says that this is the first approved treatment for non-metastatic, castration-resistant prostate cancer. The drug works by blocking the effect of androgens on a tumor.

“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,” the release says. “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.”

Approval was based on data from a randomized clinical trial of 1,207 patients with non-metastatic, castration-resistant prostate cancer. “The median metastasis-free survival for patients taking Erleada was 40.5 months compared to 16.2 months for patients taking a placebo,” FDA says. Common side effects of Erleada include fatigue, high blood pressure, rash, diarrhea, nausea, weight loss, joint pain, falls, hot flush, decreased appetite, fractures and swelling in the limbs.

FDA notes that Janssen is the first participant in its recently-announced Clinical Data Summary Pilot Program, which is intended to provide more usable information on the clinical evidence supporting drug product approvals and more transparency into the agency’s decision-making process. Soon after approval, certain information from the clinical summary report will post with the Erleada entry on Drugs@FDA and on the new pilot program landing page.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome