The Cancer Letter

Inside information on cancer research and drug development

Drugs & Targets

FDA grants Augtyro priority review for NTRK-positive locally advanced or metastatic solid tumors

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

FDA has accepted the supplemental New Drug Application for Augtyro (repotrectinib) for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, and are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity. 

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

VHIO’s novel CAR T-cell therapy demonstrates efficacy and safety in preclinical models of HER2-positive solid tumors

One-third of HER2-positive tumors express the P95HER2 protein, which associates with an aggressive form of breast cancer with a poorer prognosis. Investigators of the Vall d’Hebron Institute of Oncology’s Growth Factors Group, in collaboration with researchers of the Cancer Research Program of Hospital del Mar Research Institute, Barcelona, have developed novel chimeric antigen receptor T-cell therapy that can produce a potent antitumor response against p95HER2-expressing cells.
Drugs & Targets

FDA approves new alternative standard related to mammography report assessments

FDA recently approved Alternative Standard #25 related to the Mammography Quality Standards Act. Alternative Standard #25 allows the interpreting physician to provide an assessment of “Incomplete: Need additional imaging evaluation” for the follow-up report issued within 30 calendar days of an initial report that received an assessment of “Incomplete: Need prior mammograms for comparison.”
Drugs & Targets

FDA approves Ziihera for HER2+ biliary tract cancer

FDA accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer, as detected by an FDA-approved test. Ziihera was approved under accelerated approval based on a 52% objective response rate and a median duration of response of 14.9 months as determined by independent central review. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The phase III HERIZON-BTC-302 confirmatory trial is ongoing to evaluate zanidatamab in combination with standard-of-care therapy versus standard-of-care therapy alone in the first-line setting for patients with HER2-positive BTC.
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