Aetion Updates FDA Decision Alerts Database Following FDA’s Accelerated Approval of Oncology Drug LUMAKRAS

LUMAKRAS (sotarasib) was received accelerated approval from the Food and Drug Administration (FDA). The use of real world evidence (RWE) studies supported Amgen’s FDA application for the drug, intended to be used in a subset of adult patients with non-small cell lung cancer.

“The applicant conducted three real-world, retrospective natural history studies (Studies 20180277, 20200097, and 20200132) to provide context on outcome measurements in patients receiving standard of care therapies. The studies also provided demographic and clinical characteristics for the intended patient population.” Read more here.

(Source: Nick Honig and Tony Louder, Aetion, 8/12/21)