Drugs

Nektar, BMS Nix Opdivo/Bempegaldesleukin Trials

Nektar Therapeutics and Bristol Myers Squibb have decided to end the clinical development program for bempegaldesleukin in combination with Opdivo (nivolumab) for treating renal cell carcinoma (RCC) and bladder cancer based on results from pre-planned analyses of two late-stage clinical studies of the combination therapy.

In the Phase 3 PIVOT-09 study in patients with previously untreated advanced or metastatic RCC, the companies say they were told by an independent Data Monitoring Committee that a final analysis of objective response rate (ORR) showed that combination treatment did not meet the prespecified boundary for statistical significance in comparison to the tyrosine kinase inhibitor control arm. “An interim analysis of overall survival (OS) also did not meet the prespecified boundary for statistical significance in either of these populations,” they say.

In the separate Phase 2 PIVOT-10 study, the drug combination did not reach an efficacy threshold to support continuing the program in urothelial carcinoma, according to the companies. They will review the data from both studies and plan to share the results with the scientific community at a later date.

Last month, the companies announced that two pivotal studies in melanoma would be discontinued based on results in the Phase 3 PIVOT IO-001 study in metastatic melanoma.

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