Drugs

Partial Hold on MacroGenics’ Gynecologic Cancer Therapy

FDA has placed a partial clinical hold on a MacroGenics Phase 2 (LINNET) trial of its investigational immunotherapy lorigerlimab, halting enrollment of new patients while allowing those already in the study to continue treatment. MacroGenics says the agency action followed the company’s recent decision to temporarily pause enrollment after a series of serious safety events in the study, which is evaluating lorigerlimab in patients with gynecologic cancers.

The safety concerns involved four patients treated at a dose of 6 mg/kg every three weeks. Reported events included two cases of Grade 4 thrombocytopenia, one case of Grade 4 myocarditis, and one case of Grade 4 neutropenia accompanied by septic shock, according to the company, adding that the latter resulted in a Grade 5 event (patient death).

To date, 41 participants have received the 6 mg/kg dose across the platinum-resistant ovarian cancer and clear cell gynecologic cancer cohorts, it says. Under the partial clinical hold, no new patients may be enrolled until FDA lifts the restriction. However, patients currently participating in the trial may continue receiving lorigerlimab.

Lorigerlimab is described as an investigational bispecific DART molecule designed to simultaneously target PD-1 and CTLA-4, two immune checkpoint proteins involved in regulating immune responses against tumors. Dual checkpoint inhibition has shown clinical activity in several cancers but is also associated with increased immune-related toxicities.

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