Oral Paclitaxel is Granted Priority Review by FDA

The FDA recently granted priority review for oral paclitaxel and encequidar (Athenex) for the treatment of metastatic breast cancer.

FDA priority review is granted when the drug, if approved, would be significantly more effective in the treatment, diagnoses, efficacy, or safety than the current standard application.

The approval is based on a single randomized, controlled clinical phase 3 trial. The study compared oral paclitaxel monotherapy to intravenous (IV) paclitaxel monotherapy. The study achieved statistically significant improvements to overall response rate and a lower neuropathy for oral paclitaxel compared with IV paclitaxel.

We are working diligently with the FDA on this Priority Review to bring oral paclitaxel to patients with metastatic breast cancer as quickly as possible,” said Rudolf Kwan, MBBS, MRCP, chief medical officer of Athenex in a press release. “Intravenous (IV) paclitaxel is a foundational chemotherapy in multiple tumor types and we plan to invest in broadening the label and uses for oral paclitaxel.”

The FDA is not currently planning an advisory committee to discuss the application; however, a target action date of February 28, 2021 has been set.

REFERENCE

Athenex Announces FDA Acceptance for Filing of U.S. NDA for Oral Paclitaxel and Encequidar in Metastatic Breast Cancer with Priority Review [News Release] September 1, 2020; Buffalo, NY. https://ir.athenex.com/news-releases/news-release-details/athenex-announces-fda-acceptance-filing-us-nda-oral-paclitaxel. Accessed November 2, 2020.