FDA grants priority review to oral paclitaxel regimen for metastatic breast cancer
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The FDA granted priority review to oral paclitaxel and encequidar for the treatment of metastatic breast cancer.
A randomized phase 3 study compared the combination of oral paclitaxel and encequidar (Athenex) — a novel, highly specific, potent P-glycoprotein pump inhibitor that increases absorption of oral paclitaxel — with IV paclitaxel among women with metastatic breast cancer.
As Healio previously reported, the oral regimen significantly improved the overall response rate compared with IV paclitaxel and appeared associated with a lower rate of neuropathy.
The FDA is expected to make a decision on a new drug application for this regimen by Feb. 28.
“We continue to finalize our commercial preparations to ensure a successful launch of oral paclitaxel, if approved,” Johnson Lau, MBBS, MD, FRCP, chairman and CEO of Athenex, said in a company-issued press release. “We see oral paclitaxel as a potentially important alternative to IV infusions, especially during the current pandemic, as it may allow [patients with cancer] to take the oral chemotherapy at home.”
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