Type A Meeting Between FDA and Athenex Discusses Oral Paclitaxel Plus Encequidar for Metastatic Breast Cancer

The FDA held a Type A meeting with Athenex, Inc. to discuss the development of oral paclitaxel (Oraxol) plus encequidar (Opac+E) for the treatment of metastatic breast cancer.¹

In February, the FDA issued a complete response letter (CRL) to Athenex citing their safety risk concerns regarding oral paclitaxel plus encequidar. These concerns included the observed increase in neutropenia-related sequelae in the oral paclitaxel arm of the trial, as well as the reported uncertainty by blinded independent central review (BICR) surrounding the primary end point of objective response rate (ORR) at week 19.²

However, at the recently held Type A meeting, the FDA has offered support and encouragement for the development of the combination regimen, agreeing that that a new, well-designed and well-conducted trial might adequately address those deficiencies, according to Athenex, the manufacturer of the drugs.

In order to offer a more complete summary for the risks and benefits associated with the drugs, Athenex produced further analyses, including overall survival (OS) data on patient subgroups, at the meeting. Athenex also suggested that they collected additional OS data to help structure a new and improved clinical study.

“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,” shared Rudolf Kwan, MD, chief medical officer of Athenex, in a press release. “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, a global biopharmaceutical company, has received an orphan drug designation from the FDA to develop oral paclitaxel and encequidar to treat cutaneous angiosarcoma. Additionally, the European Commission has granted Athenex an orphan designation for the treatment of soft tissue sarcoma with oral paclitaxel and encequidar.

References

• Athenex provides update from FDA type A meeting regarding oral paclitaxel plus encequidar for the treatment of metastatic breast cancer. News release. Athenex. July 6, 2021. Accessed July 7, 2021. https://ir.athenex.com/news-releases/news-release-details/athenex-provides-update-fda-type-meeting-regarding-oral
• Athenex receives FDA complete response letter for roal paclitaxel plus encequidar for the treatment of metastatic breast cancer. News release. Athenex. March 1, 2021. Accessed July 7, 2021. https://ir.athenex.com/news-releases/news-release-details/athenex-receives-fda-complete-response-letter-oral-paclitaxel