Drugs

IDEAYA Plans Phase 3 Study in Lung Cancer After FDA Meeting

IDEAYA Biosciences says it had a successful FDA Type C meeting to determine the Phase 3 registrational trial design for IDE849, a delta-like ligand 3 (DLL3)-targeting Topo-I-payload antibody drug conjugate (ADC) and its use in extensive stage small cell lung cancer (ES-SCLC). IDEAYA is planning to begin the study by year-end.

"Based on the FDA Type C meeting, we are targeting to initiate a randomized Phase 3 registrational study for IDE849 monotherapy in extensive stage small cell lung cancer to enable a potential accelerated approval and full approval in one seamless study design," the company says in a release.

The company says about 400 ES-SCLC patients with prior tarlatamab treatment will be enrolled in the study. “The study will be randomized 1:1 between the treatment and an investigator's choice control arm that will include topotecan and ambrucin,” it says. The primary endpoint for accelerated approval will be overall response rate (ORR) that will be evaluated by blinded independent central review (BICR), and the primary endpoint for full approval will be median overall survival. Secondary endpoints will include median duration of response by BICR, progression free survival, safety, among others.

IDEAYA notes it also has an ongoing multi-site global Phase 1 clinical trial for IDE849 in DLL3 upregulated solid tumor indications, including SCLC, and neuroendocrine carcinomas.

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