FDA fast-tracks ADC for non-small cell lung cancer 


The US Food and Drug Administration (FDA) has granted fast track designation to Mythic Therapeutics’ investigational cMET-targeting ADC, MYTX-011, for the treatment of patients with non-small cell lung cancer (NSCLC) with cMET overexpression.

The designation for Mythic, a clinical-stage biotechnology company developing next-generation antibody-drug conjugate (ADC) therapies for the treatment of a wide range of cancers, encompasses NSCLC patients with any level of cMET overexpression, including low and intermediate. 

“Receiving Fast Track designation from the FDA reinforces our focus on addressing the unmet need of patients living with cMET-positive NSCLC, who currently have few effective treatments,” said Brian Fiske, Chief Scientific Officer and Co-Founder at Mythic Therapeutics. “We are proud of this significant milestone as it highlights the potential of MYTX-011, which is enabled by our FateControl platform, to expand ADC therapy to more NSCLC patients.”

“While a small fraction of NSCLC tumours highly express cMET, a much broader patient population have tumours which overexpress cMET, but at lower levels,” said KisMET-01 study investigator Rebecca Heist, Massachusetts General Hospital. “It’s important we continue investigating the potential of MYTX-011 for patients with NSCLC who need new approaches to treating their cancer as many either do not respond to, or develop resistance to, existing treatment options.”

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