Drugs

FDA Accelerated Approval for Jazz Modeyso

FDA has granted accelerated approval to Jazz Pharmaceuticals’ Modeyso (dordaviprone), a protease activator, for adult and pediatric patients one year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. An agency announcement says Modeyso is the first approval of a systemic therapy for H3 K27M-mutant diffuse midline glioma.

The drug’s efficacy was evaluated in an integrated efficacy population of 50 adult and pediatric patients with recurrent H3 K27M-mutant diffuse midline glioma enrolled across five open-label U.S. trials. The major outcome measure was overall response rate, with duration of response as a secondary outcome measure. The overall response rate was 22% and the median duration of response was 10.3 months.

The Modeyso labeling includes Warnings and Precautions for hypersensitivity, QTc interval prolongation, and embryo-fetal toxicity.

FDA says the review used the Assessment Aid and was granted priority review.

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

Read more

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