Source – Mirati Therapeutics
Mirati Therapeutics has faced a setback in its quest to market its lead KRAS inhibitor Krazati, also known as adagrasib, in Europe for patients with a certain type of advanced lung cancer. The company announced on Friday that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had rejected its application for conditional marketing approval for Krazati, which targets the KRAS G12C mutation. Mirati said it “disagrees with the opinion” and plans to ask for a formal review.
Krazati is one of two FDA-approved drugs that target KRAS, a protein that has long been considered too difficult to drug and that drives many cancers. The other drug is Lumakras from Amgen, which was approved in May 2021, seven months before Krazati. While Lumakras has seen its U.S. sales drop, Krazati has exceeded analysts’ expectations in its first full quarter on the market, bringing in $6.3 million in the first three months of 2023. Mirati said CHMP acknowledged that Krazati has a positive risk-benefit profile but did not meet “certain requirements” for conditional marketing approval. Mirati argued that Krazati deserves approval despite the presence of another conditionally approved KRAS G12C inhibitor and that Krazati has a distinct clinical profile.
The company highlighted some of the features that set Krazati apart from its rival, such as its safety profile, its potential activity in the brain and its ability to work well with other cancer drugs.
“We remain committed to our belief in the potential of adagrasib to provide hope for patients in the European Union.”
– David Meek, chief executive officer of Mirati
Mirati’s EU application was based on data from the Phase II part of the Krystal-1 study, which tested Krazati at 600 mg twice a day in 116 patients with previously-treated, KRAS G12C-mutated advanced lung cancer. The drug showed a 43% tumor response rate in the study.
Interestingly, Mirati says it’s already providing Krazati to some European patients on “individual requests from healthcare professionals.” The company “intends to continue supplying Krazati under early access in EU member states.” The decision will not affect any of Mirati’s clinical trials, the company said. Enrollment in the company’s confirmatory Phase III trial for adagrasib is “progressing as expected.” The company expects to report progression-free survival and interim overall survival results sometime in the first half of 2024.
