GSK's Jemperli First-Line Endometrial Cancer Approval Fillip Ahead Of Keytruda Advance

With Restricted Label

The major’s PD-L1 inhibitor is the first to win US approval for the treatment of first-line endometrial cancer in combination with chemotherapy, but an unsurprisingly narrow label means rival Merck & Co.’s Keytruda could still make a splash in this indication.  

pink paper cut out of uterus
There Are 60,000 New Cases Of Endometrial Cancer Each Year In the US • Source: Shutterstock
Key Takeaways:
  • The label is limited to in mismatch repair deficient or microsatellite instability-high disease.

GSK plc’s Jemperli has received a US Food and Drug Administration green light for use with chemotherapy in mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) first-line endometrial cancer earlier than expected, but competition from Merck & Co., Inc. is on the horizon.

Jemperli (dostarlimab) first won US approval in 2021 for second-line treatment of patients with dMMR recurrent or advanced endometrial cancer,...

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

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.

Dizal’s Zegfrovy Wins US NSCLC Approval, At Lower Dose Than In China

 

Dizal's EGFR inhibitor Zegfrovy approved in US as new once-daily oral option for second-line NSCLC with EGFR exon 20 insertion mutations, at lower dose than in China.

Regeneron Wins Long-Sought FDA Nod For Lynozyfic In Myeloma

 

The agency gave accelerated approval to the BCMAxCD3-directed bispecific antibody, which had been the subject of an August 2024 CRL.

Pipeline Watch: Eleven Approvals And ADA Readouts Dominate

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

Compass Pathways’ Antidepressant Advances In An Increasingly Tough Psychedelic Market

 
• By 

Psychedelics appear to be in vogue after years of being relegated to alternative medicine. But investor pushback after the highly anticipated release of Phase III trial data by Compass Pathways reveals an increasingly high bar for development.

Eolo Pharma Advances In Obesity With Thermogenesis Approach

 
• By 

Emerging Company Profile: Early-stage biotech Eolo will seek cash and deals for its novel obesity drug SANA after positive Phase I results for weight loss, lean muscle mass preservation and fat mass reduction.

BioMarin’s Roctavian Continues to Shine In Hemophilia A Despite Commercial Woes

 

Roctavian shows durable bleed control and safety over five years, but high costs and access hurdles limit its commercial outlook.