Athenex To Redeploy Resources After FDA Meeting on Oral Paclitaxel in Metastatic Breast Cancer

By Michael Dabaie

Athenex Inc. said that after a Type A meeting with the U.S. Food and Drug Administration regarding the new drug application for oral paclitaxel and encequidar in metastatic breast cancer, it determined it would redeploy resources.

"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," Chief Executive Johnson Lau said Monday.

FDA Type A meetings are meetings to help an otherwise stalled product development program proceed.

Athenex said the purpose of the meeting was to review with the FDA a proposed design for a new clinical trial intended to address the deficiencies FDA raised earlier this year and discuss the potential regulatory path forward for oral paclitaxel in metastatic breast cancer in the U.S.

Write to Michael Dabaie at [e-mail]

(END) Dow Jones Newswires

10-11-21 0849ET