NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended regulators approve AstraZeneca's EGFR inhibitor Tagrisso (osimertinib) plus pemetrexed and platinum-based chemotherapy as a first-line treatment for patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer.
To be eligible for the Tagrisso-chemo combination, patients must have EGFR exon 19 deletions or exon 21 (L858R) mutations.
Tagrisso monotherapy is already approved in the US, EU, China, and Japan for treating EGFR-mutated locally advanced or metastatic NSCLC in the first-line setting; for EGFR T790M-mutated advanced NSCLC; and for adjuvant treatment of early-stage EGFR-mutated NSCLC.
Now, CHMP is recommending the Tagrisso-chemo combo for patients with advanced EGFR-mutated NSCLC after reviewing data from the FLAURA2 Phase III trial. The study, results from which were published in the New England Journal of Medicine, showed that the addition of chemo to Tagrisso reduced the risk of disease progression or death by 38 percent compared to just Tagrisso, the current standard of care. The overall survival data within FLAURA2 were immature at the second interim analysis, but the study will continue until the data are more mature.
The US Food and Drug Administration approved this same indication earlier this year.
"The FLAURA2 results build on the established efficacy of osimertinib monotherapy in patients with EGFR-mutated lung cancer, demonstrating a meaningful nine-month improvement in progression-free survival with the addition of chemotherapy," David Planchard, a thoracic oncologist at the Gustave Roussy Institute of Oncology and the principal investigator for FLAURA2, said in a statement. "Today’s positive recommendation is a vital step towards providing patients in Europe with an additional treatment option capable of extending the time before their disease progresses."