Drugs

Partial Hold on Blueprint’s Cancer Drug

FDA has placed a partial clinical hold on a Blueprint Medicines early-stage trial testing experimental cancer drug BLU-222 because of safety concerns, according to a Reuters report. Some patients faced episodes of light sensitivity and blurred vision, the company says.

The 366-participant drug dosing trial was initiated 4/2023 for treating tumors, such as breast cancer, ovarian cancer, endometrial cancer, among others, according to a U.S. government database. Blueprint says it is working with FDA to investigate the adverse events and amend the trials’ protocol to ensure adequate monitoring is occurring.

Wedbush Securities analyst David Nierengarten says he was encouraged by the absence of uveitis in patients on the drug. Uveitis reports led to the discontinuation of Nuvation Bio’s similar cancer drug study last year, according to Reuters. The visual issues in both drugs suggests it could be a class effect, Citigroup analyst David Lebowitz says.

Patients with advanced solid tumors currently enrolled in the trial will continue on the drug, Blueprint Medicines said, while additional enrollments will be paused until the partial clinical hold is resolved.

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