Biologics

BeiGene BLA Filed for Gastric Cancer

FDA has accepted for review a BeiGene BLA for Tevimbra (tislelizumab) for combination use with fluoropyrimidine- and platinum-containing chemotherapy in treating locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. The agency has set a December user fee review action target date.

The submission is based on data from the global RATIONALE-305 trial, which met its primary endpoint of overall survival of 15.0 months for patients treated with Tevimbra in combination with investigator’s choice of chemotherapy compared to 12.9 months for patients treated with placebo plus chemotherapy, according to the company. “Additionally, Tevimbra plus chemotherapy was associated with a higher objective response rate (47.3% vs. 40.5%) and median duration of response (8.6 months vs. 7.2 months) compared to placebo plus chemotherapy,” it says, adding that median progression-free survival for Tevimbra plus chemotherapy was 6.9 months vs. 6.2 months for those on placebo.

Tislelizumab is described as an immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. “It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors,” BeiGene says.

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