Opdivo receives positive CHMP opinion as adjuvant treatment for GEJ cancer patients with residual pathologic disease following chemoradiotherapy

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The Committee for Medicinal Products for Human Use of the European Medicines Agency as recommended approval of Opdivo (nivolumab) for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. 

Opdivo is sponsored by Bristol Myers Squibb.

The European Commission, which has the authority to approve medicines for the European Union, will now review the CHMP recommendation.

The positive opinion is based on results from the phase III CheckMate -577 trial, which showed that treatment with Opdivo following neoadjuvant CRT and complete surgical resection doubled the primary endpoint of disease-free survival compared to placebo in the all-randomized population. The safety profile of Opdivo was consistent with previously reported studies. Results from CheckMate -577 were presented at the 2020 European Society for Medical Oncology virtual congress in September 2020 and at the American Society of Clinical Oncology annual meeting in June 2021.

Opdivo is approved in the United States for the adjuvant treatment of completely resected esophageal or GEJ cancer with residual pathologic disease in patients who have received neoadjuvant CRT.

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The University of California, San Francisco and global oncology communities mourn the death of Felix Y. Feng, MD, a radiation oncologist and a leading figure in genitourinary cancer research. A professor of radiation oncology, urology and medicine, and vice chair of translational research at the UCSF Helen Diller Family Comprehensive Cancer Center, Feng died from cancer on Dec.10, 2024. He was 48.
The late Felix Feng, MD (center) with researchers Jonathan Chou, MD, PhD (left) and Lisa Chesner, PhD (right), in 2019.Photo by Noah BergerFelix Y. Feng, a genitourinary cancer research leader, died on Dec. 10, 2024. He was 48.This article is republished with permission by NRG Oncology.Dr. Feng was the former NRG Oncology Genitourinary Cancer Committee chair and an RTOG Foundation member. After years of dedicated and enthusiastic commitment to the NRG and previously the RTOG Genitourinary Cancer Committee, chairing or co-chairing 13 research protocols for NRG and RTOG, Dr. Feng was appointed committee chair in March 2018, following in the footsteps of Dr. Howard Sandler, his mentor. Dr. Feng was also a member of the RTOG Foundation Board of Directors.

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