Drugs

FDA Turns Down Athenex Breast Cancer Drug

FDA has issued Athenex a complete response letter on an NDA for oral paclitaxel plus encequidar for treating metastatic breast cancer. The letter indicated concern about a safety risk due to an increase in neutropenia-related sequelae in patients on the oral paclitaxel arm compared with the intravenous paclitaxel arm in the study data submitted, the company says. “The FDA also expressed concerns regarding the uncertainty over the results of the primary endpoint of objective response rate (ORR) at week 19 conducted by blinded independent central review (BICR),” Athenex says. The agency reportedly stated that the BICR reconciliation and re-read process may have introduced unmeasured bias and influence on the BICR.

In light of the concerns, the company says FDA has recommended that it conduct a new adequate and well-conducted clinical trial in a patient population with metastatic breast cancer representative of the population in the U.S. “The agency determined that additional risk mitigation strategies to improve toxicity, which may involve dose optimization and/or exclusion of patients deemed to be at higher risk of toxicity, are required to support potential approval of the NDA,” it says.

FDA 9/2020 accepted the NDA for priority review and the submission was supported by data from a single pivotal Phase 3 study. The company previously reported that the study achieved its primary endpoint by showing statistically significant improvement in overall response rate, along with a lower neuropathy, for oral paclitaxel compared to intravenous paclitaxel.

Athenex says it plans to request a meeting with FDA to discuss the agency’s letter and to discuss the design and scope of a clinical trial to address the agency’s requirements.

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