Everest Medicines secures NMPA approval for Trodelvy’s clinical trial

Everest Medicines secures NMPA approval for Trodelvy’s clinical trial

by Pranali Mehta

Asian biopharmaceutical major, Everest Medicines, has reportedly secured the approval of China’s NMPA (National Medical Products Administration) for the clinical trial of sacituzumab govitecan (Trodelvy). The candidate will be effectively utilized in the treatment of HR+/HER2- metastatic breast cancer patients having at least two earlier failed chemotherapy regimens.

According to Everest Medicines’ Chief Medical Officer, Oncology, Yang Shi, HR+/HER2- breast cancer is prevalent in over 60 per cent of all breast cancers diagnosed in the country. Despite significant advancements in therapeutic devices, treatment options continue to be extremely limited for women having this metastatic disease subset, stated Shi.

The late-stage sacituzumab govitecan data generated till date and the latest breast cancer treatment clinical guidelines in China effectively strengthen the reassuring clinical activity of Trodelvy in HR+/HER2- mBC patients, added Shi, further expressing that Everest Medicines is thrilled  to develop on this inclusive data and research legacy intended to help progress the standards of care for patients in Asia.

This Clinical Trial Application reportedly assists Everest Medicines in the initiation of EVER-132-002, the third Phase registration clinical trial designed for the comparison and assessment of safety and efficacy of sacituzumab govitecan against the Treatment of Physician’s Choice in Asian patients. The trial is poised to enroll nearly 330 HR+/HER2- mBC patients in South Korea, Mainland China, and Taiwan, cite sources.

The U.S. FDA had previously granted advanced approval to sacituzumab govitecan back in April 2020 for the treatment of mTNBC patients with at least two earlier therapies for metastatic disease on the basis of results obtained from a Phase 1/2 clinical trial. Reliable sources state that the recent confirmatory Phase 3 ASCENT trial has validated the fact that sacituzumab govitecan caused significant improvements in both, overall survival (OS) as well as progression free survival (PFS), over the course of a standard single-agent chemotherapy delivered to pre-treated mTNBC patients.

 

Source Credits:

https://www.globenewswire.com/news-release/2020/11/02/2118100/0/en/Everest-Medicines-Announces-Approval-of-Clinical-Trial-Application-by-China-National-Medical-Products-Administration-for-Phase-3-Registration-Trial-of-Trodelvy-for-Metastatic-Breas.html

Pranali Mehta

A chemical engineer by qualification, Pranali Mehta dutifully walked down the slated path and worked in a chemical firm for a year. Her passion for writing however, pushed her into experimenting with the same as a career. With over three years of experience in content writRead more...