Drugs

Genentech’s Tecentriq OK’d for Breast Cancer

FDA has granted Genentech accelerated approval for Tecentriq (atezolizumab) plus chemotherapy (Abraxane [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for treating adults with unresectable locally advanced or metastatic triple-negative breast cancer in people whose tumors express PD-L1. Approval was based on data showing favorable progression-free survival, the company says.

Data from the Phase 3 IMpassion130 study showed that Tecentriq plus nab-paclitaxel significantly reduced the risk of disease worsening or death by 40% compared with nab-paclitaxel alone in the target patient population. Overall survival results were “immature” with 43% of events in all randomized patients (intent-to-treat), and further data will be submitted to FDA when available, Genentech says.

Safety in the Tecentriq plus nab-paclitaxel arm appeared consistent with the known safety profiles of the individual therapies, and no new safety signals were identified with the combination, the company says. The most common side effects recorded in patients on the combination therapy were low white blood cells, tingling or numbness in the hands and feet, neutrophil count decreased, feeling tired, low red blood cells, low blood potassium level, pneumonia and increased blood level of a liver enzyme.

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