The Cancer Letter

Inside information on cancer research and drug development

Drugs & Targets

FDA grants accelerated approval to Enhertu for HER2-mutant NSCLC and companion diagnostic

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

FDA granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. 

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. 
Drugs & Targets

FDA approves first companion diagnostic for lung cancer drug

FDA has approved FoundationOne Liquid CDx to be used as a companion diagnostic for Tepmetko (tepotinib) developed by EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada. Tepmetko received accelerated approval from FDA in February 2021 and traditional approval in February 2024 for the treatment of adult patients with metastatic non-small cell lung cancer harboring mesenchymal-epithelial transition exon 14 skipping alterations. FoundationOne Liquid CDx is the first FDA-approved companion diagnostic to identify patients who may be eligible for Tepmetko.
Drugs & Targets

CHMP issues positive opinion of Sarclisa for transplant-ineligible newly diagnosed MM

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. A final decision is expected in the coming months.
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