Amgen’s Imdelltra Wins FDA Nod In Underserved SCLC Population

The DLL3-targeting bispecific antibody won accelerated approval in extensive-stage small-cell lung cancer among patients treated with platinum chemotherapy.

• Source: Shutterstock

Amgen, Inc. has an opportunity to take a leading position in a disease area with limited therapy options following accelerated approval of Imdelltra (tarlatamab-dlle) in adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed during or after platinum-based chemotherapy.

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

Pipeline Watch: Eight Approvals And Three 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.

In Brief: US FDA Rejects Regeneron’s Bid to Extend Eylea HD Dosing

 

Regeneron is disappointed by the knock-back for longer dosing intervals for its high-dose version of Eylea, but its supplemental application for a more commercially important shorter four-week regimen has received a priority review.

Seven Up For Sanofi and Regeneron With Dupixent CSU Approval

 
• By 

The IL-4/IL-13 inhibitor has been approved in the US as the first targeted therapy in over a decade for chronic itching.

Leqembi Launch Set For Germany And Austria As EU Approval Finally Comes

 

Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.

More from Scrip

Galapagos Chief Exec Stoffels Leaving, While Firm Names Spinout’s CEO

 
• By 

Paul Stoffels, the J&J research veteran who helmed Galapagos during a crucial period, will retire upon the appointment of a new CEO as the company continues its latest transformation.

MetaVia’s ‘Safe’ Obesity Drug Resonates With Analysts, But Not Investors

 
• By 

The biotech reported Phase I multiple-ascending dose data for its obesity drug for the second time in a week, but its safety and tolerability do not offset concerns about relatively unimpressive weight reduction.

Regeneron To Expand US Manufacturing, Citing Commercial And Clinical Expansion

 

The company said the main reason for expanding its manufacturing capacity was its growing US commercial portfolio and clinical pipeline.