Athenex Announces FDA Acceptance for Filing of U.S. NDA for Oral Paclitaxel and Encequidar in Metastatic Breast Cancer with Priority Review
FDA grants Priority Review and sets PDUFA target action date of
FDA indicated that it is not currently planning to hold an advisory committee meeting
“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 Dr.
The Oral Paclitaxel NDA submission is supported by data from a single pivotal Phase III study of Oral Paclitaxel for the treatment of metastatic breast cancer. The study is a randomized, controlled clinical trial designed to compare the safety and efficacy of Oral Paclitaxel monotherapy versus IV paclitaxel monotherapy. As previously reported, the study achieved its primary endpoint showing statistically significant improvement in overall response rate, along with a lower neuropathy, for Oral Paclitaxel compared to IV Paclitaxel.
The Orascovery platform was initially developed by
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Founded in 2003,
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Source: Athenex, Inc.