Innovative oral yew alcohol formula is eligible for FDA priority review for the treatment of metastasis breast cancer.

Yew alcohol, one of the most widely used chemotherapy drugs, was first approved in the United States in 1992 to treat ovarian cancer.
, however, the traditional yew alcohol formula requires patients to receive intravenous infusions in the hospital, which is inconvenient for treatment.
, the development of oral dosage forms of yew alcohol is an important direction to expand its application range.
formulation developed by Athenex is composed of yew alcohol and the new P-glycoprotein (P-gp) inhibitor encequidar.
Encequidar is the cornerstone of the company's oral drug development platform.
P-gp is a transport protein active on the surface of the gastrointestinal tract, and many anticancer drugs are the substrates of P-gp, which are transported back to the gastrointestinal tract by P-gp when taken or so, limiting their absorption.
Encequidar is a P-gp inhibitor.
it is not absorbed, so it partially inhibits P-gp activity in the intestines without interacting with P-gp in other parts of the body.
improves drug absorption while reducing side effects on other parts of the body.
Encequidar's role (Photo: Athenex.com) This application was supported by a randomized, active-controlled, critical Phase 3 clinical trial.
it aims to compare the safety and effectiveness of oral yew alcohol monodrive therapy with intravenous yew alcohol monotherapy for metastasis breast cancer patients.
clinical trial results showed that oral yew alcohol showed significant improvement in the main therapeutic endpoints compared to intravenous yew alcohol.
the total remission rate (ORR) of the oral yew alcohol group was 36%, compared with 24% in the intravenous yew alcohol group.
patients who experienced remission in the oral yew alcohol group, the proportion of patients who had a duration of more than 150 days was 2.5 times higher than intravenously administered yew alcohol.
and the number and severity of neuropathic adverse events in the oral yew alcohol group were significantly lower than intravenously.
: s1. Athenex Announces FDA Acceptance for Filing of U.S. NDA for Oral Paclitaxel and Encequidar in Metastatic Breast with Priority Review. Retrieved September 1, 2020, from.