The Cancer Letter

Inside information on cancer research and drug development

Drugs & Targets

FDA accepts supplemental BLAs for two Opdivo regimens

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print
BYLINE
IN THIS ISSUE
DOWNLOAD PDFTABLE OF CONTENTS

FDA accepted the supplemental Biologics Application for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage 2A to 3B non-small cell lung cancer. FDA assigned a Prescription Drug User Fee Act goal date of Oct. 8. 

To access this subscriber-only content please log in or subscribe.

If your institution has a site license, log in with IP-login or register for a sponsored account.*
*Not all site licenses are enrolled in sponsored accounts.

Login Subscribe
Table of Contents

YOU MAY BE INTERESTED IN

Clinical Roundup

Tecentriq + tiragolumab does not improve OS, updated phase III data finds

Genentech’s phase III SKYSCRAPER-01 study, evaluating tiragolumab combined with Tecentriq (atezolizumab) compared to Tecentriq alone for patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer, did not reach the primary endpoint of overall survival at the final analysis. The overall safety profile observed remained consistent with longer follow-up, and no new safety signals were identified. The detailed data will be presented at a medical meeting in 2025.
Drugs & Targets

Merus and Partner Therapeutics announce license agreement for the U.S. commercialization of zenocutuzumab in NRG1 fusion-positive cancer

Merus a clinical-stage oncology company developing innovative, full-length multispecific antibodies and Partner Therapeutics Inc., a private, fully-integrated biotechnology company with a focus in hematology and oncology, announced they have entered into an agreement in which Merus has exclusively licensed to PTx the right to commercialize zenocutuzumab (Zeno, also called Bizengri) for the treatment of NRG1 fusion-positive cancer in the U.S.
In Brief

Roy Herbst receives Ezra Greenspan Award from Chemotherapy+ Foundation

Roy S. Herbst (middle) receives his award at the Innovation Gala of The Chemotherapy+ Foundation, with Robert Winn (left), director and Lipman Chair in Oncology at VCU Massey Comprehensive Cancer Center, and Katerina Politi (right), scientific director of YCC’s Center for Thoracic Cancers.Roy S. Herbst was awarded the Ezra Greenspan Award at the Innovation Gala of The Chemotherapy+ Foundation on Nov. 19 in New York City. 
Table of Contents

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login

Site license subscribers:
Log in with your IP | Register a sponsored account