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Tanja Obradovic reflects on first KRAS G12C mutation inhibitor approval
Aug 26, 2024, 19:50

Tanja Obradovic reflects on first KRAS G12C mutation inhibitor approval

Tanja Obradovic posted on LinkedIn:

“First KRAS G12C mutation inhibitor just got approval in China. NMPA approved fulzerasib for the treatment of advanced non-small cell lung cancer (NSCLC) patients with tumors positive for KRAS G12C mutation who have received at least one prior therapy. This is the first China-developed KRAS G12C inhibitor developed by GenFleet Therapeutics and Innovent Biologics and it showcases rapid advances of China-based landscape in targeted oncology.

PhII KROCUS study of fulzerasib with cetuximab in the first line NSCLC was presented at ASCO 2024 and it remains to be seen if global PhIII in NSCLC will be coming.

This development in NSCLC follows previous BTD approval from NMPA granted to fulzerasib for the treatment of advanced colorectal cancer (CRC) patients with KRAS G12C mutation who have received at least two systemic therapies as well as announcement of FDA green light for pivotal PhIII trial in CRC.”

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Source: Tanja Obradovic/LinkedIn

Tanja Obradovic is the Vice President of Oncology Scientific Affairs at ICON PLCh. She has over 20 years of clinical research experience and has led major pharmaceutical companies for 13 years. Her research focuses on small molecules, antibodies, cell and gene therapy, and major immunotherapy of PD1 inhibitors.