Drugs

Athenex Scraps NDA on Paclitaxel Plus Encequidar

Athenex has decided to abandon its continued development of oral paclitaxel plus encequidar for treating metastatic breast cancer. After the company received an NDA complete response letter earlier this year, which recommended an additional clinical study before considering the submission for approval, the company requested a Type A meeting with the agency to review its plans for such a study. “After careful consideration of the FDA feedback, we have determined to redeploy our resources to focus on other ongoing studies of oral paclitaxel and our promising CAR-NKT and TCR-T cell therapies to maximize value for all stakeholders,” the company says.

FDA’s 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, Athenex said at the time. “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),” the company said. The agency reportedly stated that the BICR reconciliation and re-read process may have introduced unmeasured bias and influence on the BICR.

Athenex said FDA had 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 said.

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