Biologics

Priority Review for Imfinzi sBLA in Lung Cancer

FDA has accepted for priority review an AstraZeneca supplemental BLA for Imfinzi (durvalumab) and its use in patients with limited-stage small cell lung cancer whose disease has not progressed following platinum-based concurrent chemoradiotherapy. The company says a review action target date is expected during the fourth quarter of this year.

The submission is based on data from the ADRIATIC Phase 3 trial that showed Imfinzi reduced the risk of death by 27% versus placebo, AstraZeneca says, adding that estimated median overall survival was 55.9 months for Imfinzi versus 33.4 months for placebo. Imfinzi also reduced the risk of disease progression or death by 24% versus placebo, it says.

The human monoclonal antibody works by binding to the PD-L1 protein and blocking the interaction of PD-L1 with the PD-1 and CD80 proteins, “countering the tumor's immune-evading tactics and releasing the inhibition of immune responses,” the company says. It is currently approved for treating unresectable, Stage III non-small cell lung cancer in patients whose disease has not progressed after chemoradiotherapy.

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