Drugs

Fennec Pharma Hit with 2nd Complete Response

FDA has issued Fennec Pharmaceuticals a second complete response letter on its NDA for Pedmark (sodium thiosulfate, intravenous) for preventing ototoxicity (hearing loss) associated with cisplatin chemotherapy in pediatric patients with localized, non-metastatic, solid tumors. The letter again cited “manufacturing deficiencies,” which the company says need to be satisfactorily resolved before the submission can be approved.

Fennec’s first complete response letter was issued 8/20/2020 and cited manufacturing concerns from a pre-approval inspection that must be resolved prior to approving the drug (see earlier story). The NDA was resubmitted in June, with the agency setting a user fee review action date of 11/27.

Fennec says it is common for platinum-based therapies to cause ototoxicity in pediatric patients. The submission was based on data from two Phase 3 clinical studies of survival and reduction of ototoxicity — the Clinical Oncology Group Protocols ACCL0431 and SIOPEL 6. Data showed that sodium thiosulfate protects against cisplatin-induced hearing loss in children and is not associated with serious adverse events, the company says.

Fennec plans to request a Type A meeting with the agency to discuss the issues and “other matters” described in the recent letter.

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