Biologics

Priority Review for Tecentriq Plus Chemo in Breast Cancer

FDA has accepted for priority review a Genentech supplemental BLA for Tecentriq (atezolizumab) plus chemotherapy (Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) for first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose disease expresses the PD-L1 protein, as determined by biomarker testing. The agency has set a user fee review action target of 3/12/2019.

The submission is based on data from the Phase 3 IMpassion130 study, which showed that the combination significantly reduced the risk of disease worsening or death (progression-free survival) compared with nab-paclitaxel alone in all randomized patients, Genentech says. However, the company says that an interim analysis did not demonstrate statistical significance for overall survival in the intent-to-treat population, but the combination did show a clinically meaningful overall survival improvement in the PD-L1-positive population. Safety in the Tecentriq plus nab-paclitaxel arm appeared to track the known safety profiles of the individual therapies, it adds, with no new safety signals being identified with the combination.

Currently, Genentech says it has seven ongoing Phase 3 studies investigating Tecentriq in TNBC, including early and advanced stages of the disease.

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