NEW YORK – The US Food and Drug Administration on Monday accepted Bristol Myers Squibb's application seeking approval for the KRAS inhibitor Krazati (adagrasib) plus Eli Lilly's EGFR inhibitor Erbitux (cetuximab) for previously treated KRAS G12C-mutated locally advanced or metastatic colorectal cancer.
The FDA accepted the supplemental new drug application (sNDA) for priority review and will decide on approval by June 21, 2024.
The application was based on data from the Phase I/II KRYSTAL-1 study. Results reported last year from the combination treatment in the colorectal cancer cohort of KRYSTAL-1 demonstrated a response rate of 46 percent along with a duration of response of 7.6 months and the median progression-free survival of 6.9 months.
"Pretreated KRAS G12C-mutated colorectal cancer is associated with poor outcomes and the current standard of care offers limited clinical benefit for patients," said Anne Kerber, head of late clinical development for hematology, oncology, and cell therapy at Bristol Myers Squibb. "The acceptance of this filing for Krazati in combination with cetuximab is a positive step toward providing a potential new option for patients and their physicians."
Krazati is approved in the US, UK, and Europe for previously treated patients with locally advanced or metastatic non-small cell lung cancer harboring a KRAS G12C mutation. Those approvals were also based on data from lung cancer cohorts of the KRYSTAL-1 trial.
Amgen, Krazati's main competitor in this space, said last year it would seek approval of its KRAS inhibitor Lumakras (sotorasib) plus its EGFR inhibitor Vectibix (panitumumab) for patients with KRAS G12C-mutant metastatic colorectal cancer.
Last year, BMS acquired Mirati Therapeutics, the maker of Krazati, in a deal worth $4.8 billion.