NEW YORK – The US Food and Drug Administration on Wednesday approved AstraZeneca's Tagrisso (osimertinib) for certain patients with stage III EGFR-mutated non-small cell lung cancer.
The EGFR inhibitor is indicated for patients with tumors harboring exon 19 deletions or exon 21 (L858R) mutations, as detected by an FDA-approved test. Patients' tumors must be unresectable but can't have progressed during or after platinum-based chemotherapy and radiation, either together or sequentially.
The FDA based its approval on the results of the Phase III LAURA clinical trial, in which Tagrisso improved median progression-free survival versus placebo by more than three years. Among patients treated with Tagrisso, the median progression-free survival was 39.1 months, compared to 5.6 months for patients on placebo, which translated to an 84 percent reduction in the risk of disease progression or death for Tagrisso-treated patients.
The overall survival data from LAURA are not yet mature, but AstraZeneca is continuing to assess these outcomes as a secondary endpoint.
Tagrisso, a third-generation EGFR tyrosine kinase inhibitor, is already approved as first-line treatment for metastatic EGFR-mutated NSCLC and as later-line treatment for metastatic EGFR T790M-mutated NSCLC. In earlier-stage EGFR-mutated NSCLC, the drug is approved for adjuvant treatment after tumor resection, and in locally advanced or metastatic EGFR-mutated NSCLC, Tagrisso is approved in combination with chemo.
In a presentation of the LAURA data at the American Society of Clinical Oncology's annual meeting in June, Suresh Ramalingam, a medical oncologist at Emory University's Winship Cancer Institute, noted that these previously approved Tagrisso indications had left out a large patient population whose tumors were not metastatic, but not surgically resectable either due to involvement of nearby organs or too many lymph nodes. According to Ramalingam, this is the case for 60 percent to 90 percent of stage III NSCLC patients. These patients will now be eligible for Tagrisso under the latest approval.