FDA Approves Osimertinib For Certain Patients With Unresectable, Stage III EGFR-Mutated NSCLC

The US Food and Drug Administration (FDA) has approved osimertinib (Tagrisso, AstraZeneca) to treat certain adults who have unresectable, stage III non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 (L858R) mutations, as detected by an FDA-approved test. The approval is for patients whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy (CRT).

The approval follows a priority review by the FDA. The review was based on results from the phase 3 LAURA trial presented during a plenary session at the 2024 American Society of Clinical Oncology Annual Meeting by Suresh Ramalingam, MD, of the Winship Cancer Institute of Emory University. The results were also simultaneously published in The New England Journal of Medicine.

“This approval represents a major breakthrough for patients with stage III, EGFR-mutated lung cancer who will now have the opportunity to benefit from osimertinib,” Dr. Ramalingam said in a statement. “Patients treated with osimertinib lived without disease progression by more than 3 years in the LAURA trial, and this impressive benefit underscores the importance of diagnosing and testing lung cancer patients as early as possible.”

The LAURA trial showed that osimertinib reduced the risk of disease progression or death by 84% compared to the placebo (hazard ratio 0.16; 95% CI, 0.10-0.24; P<.001) as assessed by blinded, independent central review. The median progression-free survival (PFS) was 39.1 months in patients who received osimertinib, compared to 5.6 months in those who received placebo.

The overall survival (OS) results were immature at the current analysis, with 36% of pre-specified deaths for the final analysis reported, but “no trend towards a detriment was observed,” according to FDA officials. The trial is continuing to assess OS as a secondary endpoint, AstraZeneca officials said.

The most common adverse reactions, including laboratory abnormalities that occurred in at least 20% of patients, were lymphopenia, leukopenia, interstitial lung disease/pneumonitis, thrombocytopenia, neutropenia, rash, diarrhea, nail toxicity, musculoskeletal pain, cough, and COVID-19 infection.

The recommended osimertinib dose is 80 mg once daily, with or without food, until disease progression or unacceptable toxicity.

Sources: US FDA, AstraZeneca