GSK Secures Broad Label Expansion for Jemperli in First-Line Endometrial Cancer
1. FDA Approval: The FDA has expanded the label for GSK's Jemperli (dostarlimab-gxly) to include its use in combination with chemotherapy for all adult patients with primary advanced or recurrent endometrial cancer, regardless of biomarker status.
2. Treatment Indication: Jemperli plus chemotherapy is now approved for patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumors, which represent 70-75% of endometrial cancer cases.
3. Clinical Benefits: The regimen has demonstrated a statistically significant and clinically meaningful 31% reduction in the risk of death compared to chemotherapy alone.
4. Market Competition: This approval positions Jemperli as a strong competitor to Merck's Keytruda in the first-line endometrial cancer treatment market.
5. Patient Impact: The expanded approval offers new hope and treatment options for patients with primary advanced or recurrent endometrial cancer, potentially improving overall survival rates.