Biologics

Regeneron sBLA for Libtayo in Lung Cancer

FDA has accepted for review a Regeneron Pharmaceuticals supplemental BLA for PD-1 inhibitor Libtayo (cemiplimab-rwlc) in combination with chemotherapy as a first-line treatment in advanced non-small cell lung cancer (NSCLC). The user fee review action target date is 9/19. Libtayo was approved last year as a first-line monotherapy treatment for adult patients with advanced NSCLC whose tumors have high PD-L1 expression.

The submission is based on data from a 466-patient randomized, multicenter Phase 3 trial that assessed Libtayo in combination with a physician’s choice of platinum-doublet chemotherapy (Libtayo combination), compared to platinum-doublet chemotherapy alone. The trial was stopped early after the Libtayo combination demonstrated a significant overall survival improvement compared to chemotherapy alone, according to Regeneron.

On the safety side, the company says patients in the Libtayo combination (n=312) and chemotherapy alone (n=154) groups saw treatment discontinuations due to adverse events in 5% and 3% of patients, respectively. Immune-mediated adverse events occurred in 19% of patients in the Libtayo combination group.

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