Drugs

Pfizer Reports Elranatamab Hiccup on New Study

Pfizer says it has paused enrollment in a registration-enabling Phase 2 study of elranatamab after FDA requested additional data on three cases of peripheral neuropathy observed in the ongoing Phase 1 MagnetisMM-1 study. Patients experiencing clinical benefit from elranatamab may continue treatment, the company says in a 5/4 earnings release (p.13).

The Phase 2 MagnetisMM-3 study began in February to evaluate the efficacy and safety of elranatamab, administered subcutaneously, in patients with disease that is refractory to at least one agent in each of three major classes of medications approved for multiple myeloma, according to Pfizer. The study is expected to be completed 6/2022.

Late last year, Pfizer presented data from the ongoing Phase 1 trial, saying the therapy demonstrated “manageable safety and high response rates in patients with relapsed/refractory multiple myeloma including three patients whose disease relapsed on or progressed after prior BCMA-targeted therapies. At the highest dose level, which informed the dose selected for the Phase 2 study, 83% of patients achieved a clinical response. Safety was manageable across all subcutaneous dose levels with no dose-limiting toxicities observed.”

Pfizer describes elranatamab as a bispecific antibody, a novel cancer immunotherapy that binds to and engages two different targets at once. “One arm binds directly to specific antigens on cancer cells and the other activates and brings a person’s own T-cells from the immune system closer to kill the cancer cells,” it says. Elranatamab is designed to bind to BCMA which is highly expressed on the surface of multiple myeloma cells, and the CD3 receptor found on the surface of cancer-fighting T-cells, bridging them together to activate an immune response.

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