Benzinga | Nov 29, 2021 08:11AM EST

Athenex Announces UK MHRA Validation Of The Marketing Authorization Application For Oral Paclitaxel And Encequidar For Review

Athenex, Inc., (NASDAQ:ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, announced today that its Marketing Authorization Application (MAA) for oral paclitaxel and encequidar (Oral Paclitaxel) for the treatment of advanced breast cancer has been validated by the United Kingdom's (UK) Medicines and Healthcare products Regulatory Agency (MHRA) for review . The application qualifies for a 150 day assessment by which a decision on approvability of the product will be provided.

"We have been working diligently on the MAA submission to bring Oral Paclitaxel to patients with advanced breast cancer," said Dr. Rudolf Kwan, Chief Medical Officer of Athenex. "This is a key milestone for Oral Paclitaxel, the most advanced program in our Orascovery platform. The MAA validation is an important step forward in the regulatory process and underscores our commitment to making Oral Paclitaxel available to patients."

A single pivotal Phase III study of Oral Paclitaxel (KX-ORAX-001) served as the basis of the MAA. The study was a randomized, controlled clinical trial designed to compare the safety and efficacy of Oral Paclitaxel monotherapy versus IV paclitaxel monotherapy in patients with metastatic breast cancer. As previously reported, the study successfully achieved its primary endpoint showing statistically significant improvement in overall response rate (ORR), along with a lower incidence of neuropathy, for Oral Paclitaxel compared to IV paclitaxel.