Benzinga | Oct 11, 2021 08:02AM EDT

Athenex Provides Update From FDA Type A Meeting Regarding Oral Paclitaxel + Encequidar In Metastatic Breast Cancer

Athenex (NASDAQ:ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that it recently held a Type A meeting with the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for oral paclitaxel and encequidar (Oral Paclitaxel) in metastatic breast cancer (mBC). The purpose of the meeting was to review with the FDA a proposed design for a new clinical trial intended to address the deficiencies raised in the Complete Response Letter received in February 2021 and discuss the potential regulatory path forward for Oral Paclitaxel in mBC in the U.S.

"We had an informative meeting with the FDA, which was an important step to assessing the U.S. regulatory pathway for Oral Paclitaxel in mBC," said Dr. Johnson Lau, Chief Executive Officer of Athenex. "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. We also remain committed to serving patients utilizing products manufactured by our specialty pharmaceutical business (APS and APD)."