Immunocore Ready For First-Ever Launch After Kimmtrak’s US Approval

European Approval And Launch Also Expected Soon

The median pre-discount cost of Kimmtrak – the first approved TCR therapy and the first drug cleared for metastatic uveal melanoma – is $430,000, but the company says payers see the product’s value.

Brave new world concept of boy running with kite towards sunset sea horizon
Immunocore has profiled most of the relevant prescribers and payers ahead of its first US drug launch • Source: Alamy

Immunocore, Ltd. achieved several firsts with the US Food and Drug Administration approval of Kimmtrak (tebentafusp-tebn) – it is the first approved T-cell receptor (TCR) therapy, the first drug approved for metastatic uveal melanoma and Immunocore’s first approved product. But executives said in a same-day conference call that Immunocore is ready for its first-ever commercial launch.

The bispecific immunotherapy was approved on 26 January, a month before the FDA user fee date, for the treatment of...

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

J&J Seeks Schizophrenia Relapse Indication For Caplyta

 

The company is expecting US FDA approval of the drug in a bigger indication, major depressive disorder, later this year.

Novartis Secures Approval For First Malaria Therapy for Babies

 
• By 

Coartem Baby to be rolled out in eight African countries in the autumn.

Pipeline Watch: Ten Approvals And Eleven 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.

2025’s Biggest Launches – Half-Year Progress Report

 

Trial setbacks and extra regulatory scrutiny have hit the progress of some new drugs towards expected approvals this year, but early successes have boosted the commercial prospects of others. Fears of disruption from changes at the US FDA are so far unfounded.

More from Scrip

Novartis Secures Approval For First Malaria Therapy for Babies

 
• By 

Coartem Baby to be rolled out in eight African countries in the autumn.

Could Apogee Rival Regeneron/Sanofi, Lilly After Phase II Eczema Data Win?

 
• By 

Apogee Therapeutics reports data from Phase II APEX trial of its long-acting antibody against atopic dermatitis, showing similar efficacy to Regeneron/Sanofi’s Dupixent and Eli Lilly’s Ebglyss.

Finance Watch: A Mini-Surge In Follow-On Offerings Follows Positive Updates

 
• By 

Public Company Edition: A breakthrough designation, data and deals prompted big follow-on public offerings in late June and early July, including $402.5m for Cidara, $250.8m for Kymera and $230m for Dyne. Also, Revolution Medicines accessed up to $2bn from Royalty Pharma.