Krazati's colorectal cancer approval in jeopardy

The accelerated approval of Bristol Myers Squibb’s Krazati in colorectal cancer looks in doubt after the company disclosed in its first-quarter presentation that it’s discontinued its phase 3 confirmatory trial. That study is Krystal-10, which compared Krazati plus Erbitux, versus chemo, in KRAS G12C-mutant patients who had progressed on chemo. The trial had already been delayed: data had once been due in 2024, but were pushed back twice. A Krazati/Erbitux combo got the FDA accelerated nod in second-line colorectal cancer in 2024, based on the phase 1/2 Krystal-1 basket trial, but this now looks on shaky ground. Bristol didn’t give more details, but non-small cell lung cancer is the bigger use for Krazati, which sold just $205m in 2025; the company paid $4.8bn for Mirati, Krazati’s developer. Meanwhile, Amgen’s rival KRAS G12C inhibitor, Lumakras, gained full approval in second-line colorectal cancer, alongside Vectibix, in January 2025, and is also in a front-line study, Codebreak-301. The other big players here are Merck & Co, which took its contender, calderasib, into the phase 3 first-line Kandlelit-012 last year; and Roche, which is trialling various therapies, including its KRAS G12C inhibitor divarasib, in the phase 1 Intrinsic study.

Krazati's colorectal cancer trials

Source: OncologyPipeline & company presentation.