Athenex recently discussed with the U.S. Food and Drug Administration how to supplement deficiencies raised by the FDA in its complete response letter (CRL) in February concerning the clinical trials of oral paclitaxel.   

At the meeting held in the second quarter, Athenex, Hanmi Pharmaceutical’s U.S. partner, provided the FDA with additional analytical data, including overall survival (OS) data of the patient subgroups, to give a more extensive assessment of the benefits and harm of oral paclitaxel, a treatment for metastatic breast cancer.

Athenex also suggested collecting additional OS data to aid the newly designed clinical study, the U.S. company said in a news release on Tuesday.

According to Athenex, the FDA showed continuous support for developing oral paclitaxel. FDA also agreed that all deficiencies raise in the CRL could be compensated with the new design and conduction of the clinical study.

The company is doing its best to come up with the optimal design of the new clinical trials and submit it to the FDA in the fourth quarter of this year, it added.

“We appreciate the FDA’s support for the development of oral paclitaxel and encequidar in this meeting and expect to maintain a collaborative dialogue on this program,” said Dr. Rudolf Kwan, chief medical officer of Athenex. “We continue to believe that, if approved, oral paclitaxel and encequidar has the potential to address a major unmet need in metastatic breast cancer.”

In 2018, FDA approved oral paclitaxel as an orphan drug to treat cutaneous angiosarcoma. In 2019, the European Medicines Agency (EMA) also approved it for the use of soft tissue sarcoma treatment.