At a recent Oncologic Drugs Advisory Committee (ODAC) Meeting, the U.S. Food and Drug Administration (FDA) laid out its rationale for rejecting the supplemental new drug application (sNDA) for sotorasib (LUMAKRAS) submitted to convert the drug’s accelerated approval to full approval. The drug’s accelerated approval granted on May 28, 2021 “for adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy” remained in place. The primary reason given for declining the sNDA was uncertainty as regards the progression-free survival (PFS) benefit in the confirmatory phase III CodeBreaK 200 trial. The uncertainty arose from an incremental 5-week PFS effect relative to a 6-week imaging interval without an overall survival (OS) difference and concerns about potential systemic bias and study conduct issues. The FDA issued a complete response letter and required a new postmarketing study be completed no later than February 2028.

What exactly happened?

READ THE ARTICLE – https://academic.oup.com/oncolo/advance-article-abstract/doi/10.1093/oncolo/oyae042/7631018