Drugs

FDA Allows Juno Trial to Resume After Deaths

In a positive sign for Juno Therapeutics and other developers of promising CAR-T cell product candidates, FDA has removed a clinical hold on Juno’s Phase 2 clinical trial of JCAR015 (ROCKET trial) in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia. The agency placed the hold on the trial after three patient deaths, two of which occurred this month after a recent addition of fludarabine to the pre-conditioning regimen.

Earlier this week, the company submitted a complete response addressing the agency’s concerns. It proposed to continue the ROCKET trial using JCAR015 with cyclophosphamide pre-conditioning alone. The complete response included a revised patient informed consent form, a revised investigator brochure, and a revised trial protocol. Juno says its trials and plans for other CD19-directed CAR-T cell product candidates, including JCAR017, are not affected. Juno says FDA agreed to the resuming enrollment using JCAR015 with cyclophosphamide pre-conditioning only.

Novartis and Kite Pharmaceuticals are also developing CAR-T cell therapies that look to genetically engineer a patient’s own T-cells to help fight diseases.

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