Enhertu Is First ADC Approved For Tumor-Agnostic Indication

The US Food and Drug Administration approved Daiichi Sankyo/AstraZeneca’s Enhertu for metastatic HER2-positive solid tumors.

rainbow
Enhertu is approved for use across a broad spectrum of HER2-positive tumors • Source: Shutterstock

The HER2-directed antibody drug conjugate (ADC) Enhertu (fam-trastuzumab deruxtecan) is the first ADC to be approved for a broad tumor-agnostic indication, setting a path that others could follow.

Partners Daiichi Sankyo Co., Ltd. and AstraZeneca PLC announced the US Food and Drug Administration accelerated approval of Enhertu for metastatic HER2-positive (IHC 3+) tumors on 5 April...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from New Products

Bayer Has BI In Its Sights With Priority Review For HER2 Lung Cancer Drug

 
• By 

Sevabertinib gets onto the FDA's approval fast track three months after zongertinib.

Pipeline Watch: 12 Approvals And 26 Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Boehringer’s CMO On How AI, Integrated Evidence Generation Underpin Its Ambitious Launch Plans

 

The German company has big plans for the next five years or so. Scrip speaks to its chief medical officer Lykke Hinsch Gylvin about how it is using AI and other innovative approaches to make good on its ambitions.

Pipeline Watch: Eight Approvals And Nineteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

More from Scrip

In partnership with

Podcast Series: Navigating Regulatory Changes & Market Dynamics: CRO Perspectives on the Future of Clinical Trials

Insights from Novotech on Evolving Trends Impacting Global Clinical Development

Quick Listen: Scrip’s Five Must-Know Things

 
• By 

In this week's episode: Novo Nordisk’s CEO forced out; quantifying biopharma’s contribution to the US economy; a history of MASH deals; lift for AstraZeneca’s asthma ambitions; and major Japanese firms see US revenue growth.

Sun On Leqselvi US Launch Ahead, MFN Pricing And Pipeline Changes

 

Sun readies US debut of Leqselvi for alopecia areata, while PD-L1 inhibitor Unloxcyt is in the line up once the Checkpoint Therapeutics deal is completed. Management also discusses limited clarity on President Trump’s most favored nation pricing push, pipeline tweaks and M&A outlook.