Mirati Therapeutics Inc. has identified compounds acting as GTPase KRAS and/or GTPase KRAS (mutant) inhibitors reported to be useful for the treatment of cancer.
Alone or combined with chemotherapy, radiation therapy (RT) is the standard therapeutic option for the majority of non-small-cell lung cancer (NSCLC) cases. Unfortunately, the proportion of patients that experience local-regional relapse can reach 50% of cases. Data from previous investigations link KRAS mutations to radioresistance.
Just as Wall Street had begun mulling the possible fallout of the regulatory vote against full U.S. FDA clearance for Amgen Inc.’s KRAS G12C therapy for non-small-cell lung cancer, a new – albeit not entirely unexpected – development cropped up in the space. Mirati Therapeutics Inc. disclosed Oct. 9 that Bristol Myers Squibb Co. (BMS) is offering to take over the firm in a deal that could be worth as much as $5.8 billion, historically one of the larger takeovers for 2023.
A British billionaire who’s the founder and principal owner of the Tavistock Group, an international private investment fund with a portfolio that includes biotech companies, was arrested July 26 on multiple criminal charges of U.S. securities fraud, along with two private pilots whom allegedly received insider tips from him in lieu of a formal retirement plan.
Mirati Therapeutics Inc.’s cancer treatment Krazati (adagrasib) is having a tough time outside the U.S. The EMA’s Committee for Medicinal Products for Human Use (CHMP) came out with a negative opinion on an MAA for treating KRAS G12C-mutated advanced non-small-cell lung cancer (NSCLC). The ruling came with a flurry of positive CHMP opinions for companies, including Abbvie Inc., Beigene Ltd. and the Janssen Pharmaceutical Cos., plus a mixed result for Ipsen SA after a stumble earlier this week.
Providing no details, Mirati Therapeutics Inc. failed to meet its overall survival primary endpoint in the phase III Sapphire trial with sitravatinib. The receptor tyrosine kinase inhibitor was tested in combination with anti-PD-1 checkpoint inhibitor Opdivo (nivolumab, Bristol Myers Squibb Co.) vs. docetaxel in patients with second- or third-line advanced nonsquamous non-small-cell lung cancer. According to Mirati, this patient population consists of about 70,000 people in the U.S. and Europe who have derived prior benefit from a PD-(L)1 inhibitor.
Mirati Therapeutics Inc. has received FDA clearance of its IND application for MRTX-1133, a potent, oral small-molecule inhibitor of the KRAS G12D driver mutation.
In the wake of ongoing criticism over the U.S. FDA’s 2021 accelerated approval of Biogen Inc.’s Alzheimer’s drug, Aduhelm, the percentage of novel drugs receiving accelerated approval last year was the lowest it’s been since 2018.