The NMPA Accepts GenFleet Therapeutics’ NDA for GFH925 and Grants Priority Review for Lung Cancer
Shots:
- The CDE of the NMPA accepted GenFleet’s NDA for GFN925 and granted priority review based on the results from the P-II trial evaluating GFN925 as monotx. to treat advanced KRAS G12C-mutant NSCLC patients. The results from the trial are expected to be presented at ESMO Asia 2023
- The P-I evaluation of GFH925 depicted that 41/67 NSCLC patients achieved a partial response with an ORR of 61.2% & DCR of 92.5% whereas in 30 NSCLC patients treated with RP2D (600mg, BID) an ORR & DCR of 66.7% & 96.7% was seen
- GFN925, a KRAS G12C inhibitor, is being evaluated in China as a combination therapy by Innovent for NSCLC & is in P-II trial with Erbitux across Europe. Additionally, GFN925 has previously received a BTD by the NMPA for KRAS G12C mutant CRC
Ref: PR Newswire | Image: Genfleet
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
