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news.The US Food and Drug Administration (FDA) has accepted Mirati Therapeutics’ new drug application (NDA) for its therapy adagrasib to treat KRASG12C-mutated non-small cell lung cancer (NSCLC) patients.
Mirati Therapeutics’ NDA is supported by findings from the Phase II registration-enabling cohort of the KRYSTAL-1 trial.. Credit: Mirati Therapeutics, Inc.
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These patients have received at least one prior systemic therapy earlier.
Adagrasib is an investigational, potent oral small-molecule therapy which is designed to shrink difficult-to-treat cancers that are harbouring the KRASG12C mutation.
The NDA is supported by findings obtained from the Phase II registration-enabling cohort of the KRYSTAL-1 trial.
In the trial, adagrasib 600mg BID was assessed in patients with NSCLC harbouring the KRASG12C mutation who have received immunotherapy and chemotherapy previously.
In September last year, Mirati Therapeutics has reported positive top line results from this cohort.
Mirati Therapeutics president, founder and research and development head Charles Baum said: “The acceptance of our NDA for adagrasib is a significant step forward in Mirati’s ongoing efforts to advance innovative, differentiated treatment options for patients with KRASG12C cancers.
“We look forward to working with the FDA during their review of our application and potentially provide a novel option for patients with non-small cell lung cancer.”
The company stated that the FDA will review the NDA of adagrasib for Accelerated Approval (Subpart H).
Additionally, the application is being reviewed under the Real-Time Oncology Review (RTOR) pilot programme by FDA.
The programme aims to explore a better review process to ensure availability of safe treatments to patients.
The investigational therapy has also received Breakthrough Therapy Designation in the US to treat NSCLC harboring the KRASG12C mutation patients who have received at least one prior systemic therapy.
Furthermore, the company is evaluating adagrasib in an ongoing confirmatory Phase III trial, KRYSTAL-12.
