FDA this week granted accelerated approval to adagrasib (Krazati, Mirati Therapeutics), a RAS GTPase family inhibitor, for adult patients with KRASG12C-mutated locally advanced or metastatic nonsmall cell lung cancer, as determined by an FDA-approved test, who have received at least 1 prior systemic therapy. FDA also approved the Qiagen therascreen KRAS RGQ PCR kit (tissue) and the Agilent Resolution ctDx FIRST Assay (plasma) as companion diagnostics for adagrasib. The tumor tissue should be tested if no mutation is detected in a plasma specimen. “The FDA approval [of adagrasib] is conditional on a positive outcome from a phase 3 confirmatory trial – KRYSTAL-12 – which is scheduled to complete next year,” PharmaPhorum reports.
On Monday, CMS proposed regulations that would require generics to be in the lowest cost-sharing tier of plans offered in the Affordable Care Act marketplace, Stat reports. That tier “typically translates to little to no out-of-pocket spending for patients,” the article states. “While that category is referred to as the generic drug tier, an increasing number of generics are not included in the preferred list and instead sent to higher, ‘non-preferred’ coverage tiers.”