Drugs

Ideaya Bio Plans Phase 3 for Darovasertib

Ideaya Biosciences says it is advancing darovasertib, an investigational therapy for neoadjuvant uveal melanoma (UM), into a Phase 3 trial following “positive interim” Phase 2 clinical trial data and a successful FDA Type C meeting on the registrational trial design for seeking regulatory approval.

“Darovasertib has demonstrated compelling preliminary clinical efficacy and a favorable [adverse event] AE profile in the neoadjuvant UM setting, with approximately 49% of patients demonstrating greater than 30% tumor shrinkage and importantly approximately 61% eye preservation rate for enucleation patients,” the company says. “The successful FDA Type C meeting provides darovasertib a potential registrational path in neoadjuvant UM, using primary clinical endpoints of eye preservation and time to vision loss, with no detriment to EFS [event-free-survival] in the treatment arms as a secondary endpoint.” Additionally, discussions are ongoing with FDA to include objective response rate as a potential surrogate and composite endpoint to support earlier approval pathways, it says.

Darovasertib is described as a potent and selective protein kinase C (PKC) inhibitor that is being evaluated in four ongoing clinical trials, including two under a collaboration with Pfizer.

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