Benzinga | Jul 6, 2021 07:01AM EDT

Athenex Provides Update From FDA Type A Meeting Regarding Oral Paclitaxel Plus Encequidar For The Treatment Of Metastatic Breast Cancer

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, today announced that the Company held a Type A meeting with the U.S. Food and Drug Administration (FDA) during the second quarter of 2021 to discuss the deficiencies raised in the Complete Response Letter (CRL) received in February.

At the meeting, Athenex provided additional analyses, including overall survival (OS) data on patient subgroups, to provide a more comprehensive summary of the risk/benefit assessment. Athenex also proposed to collect additional OS data that could inform the design of a new clinical study.

The FDA was supportive and encouraged the Company to continue development of oral paclitaxel and encequidar for the treatment of metastatic breast cancer. The FDA also agreed that a well-designed and well-conducted trial may adequately address the deficiencies raised in the CRL. Athenex is evaluating the optimal design for a new clinical study which it intends to present to the FDA in the fourth quarter of 2021.

"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. We hope to agree on a program that is capital efficient and will result in value creation for our stakeholders."

Athenex is also developing oral paclitaxel and encequidar for the treatment of cutaneous angiosarcoma, for which it has received Orphan Drug Designation from the FDA. Athenex also received Orphan Designations from the European Commission for oral paclitaxel and encequidar for the treatment of soft tissue sarcoma.