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June 2021

Updated findings from the early-stage KRYSTAL-1 study showed that treatment with adagrasib resulted in durable responses, broad disease control, and provided extensive predicted coverage throughout the dosing interval in patients with KRAS G12Cmutant advanced non–small cell lung cancer.

An FDA Oncologic Drugs Advisory Committee meeting resulted in continued approval for 4 of 6 indications that were discussed, although all 6 indications did not demonstrate clinical benefit in confirmatory studies. The meeting, held April 27-29, evaluated anti–PD-1/PD-L1 drugs that received accelerated approvals through the FDA’s accelerated approval program, a nearly 30-year-old initiative to expedite the approval process.