Merck Reports US FDA’s Acceptance of sBLA for Keytruda Plus Chemotherapy with Priority Review for Endometrial Carcinoma
Shots:
- Merck’s sBLA for Keytruda, combined with SoC CT (carboplatin and paclitaxel) and as monotx. has been accepted by the US FDA and granted priority review for treating primary advanced/recurrent endometrial carcinoma with the decision expected on Jun 21, 2024
- The sBLA was supported by the P-III (NRG-GY018) study investigating Keytruda + SoC CT (carboplatin and paclitaxel) vs PBO + CT for treating measurable stage III, IVA, IVB or recurrent endometrial cancer patients (n=816) in pMMR and dMMR cohorts
- The results, highlighted in SGO’23 & the New England Journal of Medicine, showed reduction in the disease progression or death risk by 46% in patients with pMMR and by 70% in those with dMMR vs CT alone
Ref: Merck | Image: Merck
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
