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
Related News:- Astellas Receives the MHLW’s Priority Review for the sNDA Submitted for Padcev and Keytruda as Combination Therapy to Treat Bladder Cancer
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