Drugs

Priority Review for Genentech Tecentriq sBLA

FDA has accepted a Genentech sBLA for its Tecentriq (atezolizumab) and will give it priority review for a new indication for initial treatment, in combination with carboplatin and etoposide, of people with extensive-stage small cell lung cancer. The agency is expected to make a decision by 3/18/19.

Genentech says the sBLA is based on results from the Phase 3 IMPower 133 study that met its co-primary endpoints of overall survival and progression-free survival in the initial treatment of people with extensive-stage small cell lung cancer. No new safety signals were identified in the trial, the company says.

Tecentriq is currently approved by FDA to treat people with metastatic non-small cell lung cancer who have disease progression during or following platinum-containing chemotherapy, and who have progressed on an appropriate FDA-approved targeted therapy if their tumor has ALK or EGFR gene abnormalities.

The biologic is described as a monoclonal antibody designed to bind with the PD-LI protein expressed on tumor cells and tumor-infiltrating immune cells, blocking its interaction with both PD-1 and B7.1 receptors.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

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