The FDA has accepted Athenex Inc’s new drug application (NDA) filing for oral paclitaxel and encequidar and has granted priority review for the investigational treatment for metastatic breast cancer. According to a press release, the FDA has set a target action date of February 28, 2021.

Priority review is granted to drugs that, if approved, would be significant improvements in the safety or efficacy of the treatment, diagnosis, or prevention of serious conditions.

“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 statement. “Intravenous (IV) pacelitaxel is a foundational chemotherapy in multiple tumor types and we plan to invest in broadening the label and uses for oral paclitaxel.”

The NDA submission is supported by data from a single phase 3 study of oral paclitaxel in metastatic breast cancer. The study is a randomized, controlled clinical trial comparing the safety and efficacy of oral paclitaxel monotherapy with IV paclitaxel monotherapy. The study achieved its primary endpoint showing a statistically significant improvement in overall response rate, along with lower neuropathy in patients who received oral paclitaxel.

“We are delighted to have achieved this major milestone for Athenex,” said Johnson Lau, MBBS, MD, FRCP, in a press release. “We continue to finalize our commercial preparations to ensure a successful launch of oral paclitaxel, if approved. We see oral paclitaxel as a potentially important alternative to IV infusions, especially during the current pandemic, as it may allow cancer patients to take the oral chemotherapy at home.”

REFERENCE
Athenex Announces FDA Acceptance for Filing of US NDA for Oral Paclitaxel and Encequidar in Metastatic Breast Cancer with Priority Review [news release]. GlobeNewswire; September 1, 2020. https://www.globenewswire.com/news-release/2020/09/01/2086762/0/en/Athenex-Announces-FDA-Acceptance-for-Filing-of-U-S-NDA-for-Oral-Paclitaxel-and-Encequidar-in-Metastatic-Breast-Cancer-with-Priority-Review.html. Accessed September 1, 2020.