logo
  

AZN : Enhertu Approved In U.S. As First HER2 Directed Therapy For HER2 Mutant Metastatic NSCLC

Daiichi Sankyo and AstraZeneca's (AZN,AZN.L) Enhertu (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer or NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.

The indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR).

Enhertu is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

The accelerated approval by the FDA was based on the results from the DESTINY-Lung02 phase 2 trial, which showed Enhertu reported a confirmed objective response rate of 57.7% in patients with HER2 mutant disease.

For More Such Health News, visit rttnews.com

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Three experimental physicists - Alain Aspect, John F. Clauser and Anton Zeilinger - have won this year's Nobel Prize for physics for their achievements in quantum mechanics. Announcing the winners in Stockholm Tuesday, the Royal Swedish Academy of Sciences said the coveted prize was awarded to the trio "for experiments with entangled photons, establishing the violation of Bell inequalities and pi The United States has announced that it will be imposing new round of sanctions this week on perpetrators of violence against peaceful protestors in Iran. The United States is also holding accountable Iranian officials and entities such as the Morality Police, that are responsible for employing violence to suppress civil society, President Joe Biden said in a statement. Biden said he is gravel Factory Orders, Job Openings, and Labor Turnover Survey might be the major highlights on Tuesday. Fed speeches also will get attention. Early signs from the U.S. Futures Index suggest that Wall Street might open higher. Asian shares finished broadly up and European shares are progressing. As...
Follow RTT