Blenrep US Withdrawal Is A Big Blow To GSK’s Blockbuster Hopes

But A Comeback Remains Possible

Blenrep’s withdrawal will add to GSK’s blockbuster drought, and hopes of separate trial success for the BCMA-targeting drug in earlier stage myeloma may now be harder to achieve.

US FDA entrance sign
The FDA is now enforcing the accelerated approval commitments more strictly, including requests for withdrawals. • Source: Shutterstock, JHVEPhoto

GSK is to withdraw its multiple myeloma therapy Blenrep (belantamab mafodotin) from the US market following a US Food and Drug Administration request, as the drug has failed to show significant benefits for patients in a confirmatory study.

The request reflects a wider clampdown by the US regulator on drugs given accelerated approvals but which then fail to...

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.