Drugs

Monjuvi Approved for Follicular Lymphoma

FDA has approved Incyte’s Monjuvi (tafasitamab-cxix) in combination with lenalidomide and rituximab for treating adults with relapsed or refractory follicular lymphoma (FL).

Approval is based on data from the inMIND clinical trial, a double-blind, placebo-controlled study involving 548 patients with relapsed or refractory FL, according to an agency release. Trial participants were randomized to receive either tafasitamab or placebo, both in combination with lenalidomide and rituximab.

Data showed that the Monjuvi-treated group saw a statistically significant improvement in progression-free survival (PFS), FDA says. After a median follow-up of 14.1 months, the estimated median PFS was 22.4 months in the tafasitamab arm and 13.9 months in the placebo group, it says.

On the safety side, the agency says serious adverse reactions occurred in 33% of patients receiving tafasitamab, with serious infections reported in nearly one-quarter (24%) of this group. The drug’s prescribing information also includes warnings for infusion-related reactions, myelosuppression, and infections.

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