FDA Reviewing Oral Paclitaxel Combo as Metastatic Breast Cancer Treatment

FDA Reviewing Oral Paclitaxel Combo as Metastatic Breast Cancer Treatment
The U.S. Food and Drug Administration (FDA) is reviewing a new drug application from Athenex seeking approval of oral paclitaxel and encequidar (Oral Paclitaxel) for the treatment of metastatic breast cancer. The application has been granted priority review, and the FDA is expected to make a decision no later than Feb. 28, 2021. The FDA, according to Athenex, it is not currently planning to hold an advisory committee meeting to discuss the application. "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," Rudolf Kwan, MD, Athenex's chief medical officer, said in a press release. "We are delighted to have achieved this major milestone for Athenex," added Johnson Lau, MD, chairman and CEO of Athenex. "We continue to finalize our commercial preparations to ensure a successful launch of Oral Paclitaxel, if approved."
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