NEW YORK – AstraZeneca on Monday said the US Food and Drug Administration accepted its supplemental new drug application seeking approval for Tagrisso (osimertinib) with chemotherapy as a treatment for patients with advanced or metastatic EGFR-mutated non-small cell lung cancer.
The agency also granted priority review to the application, which commits the agency to issuing a decision within six months, as opposed to the 10 months the agency has for standard reviews. The FDA is expected to issue a decision on AstraZeneca's NDA in the first quarter of 2024.
In its application, AstraZeneca submitted data from the Phase III FLAURA2 trial, which showed that Tagrisso plus chemotherapy reduced the risk of disease progression or death by 38 percent compared to Tagrisso alone. The combination regimen extended median progression-free survival by 8.8 months to 25.5 months, compared to 16.7 months on just Tagrisso. Among patients with central nervous system metastases, the benefit with Tagrisso-chemotherapy was even greater, yielding a 53 percent reduction in the risk of disease progression or death and extending median progression-free survival by 11.1 months over single-agent Tagrisso.
Overall survival data were immature at the time of the analysis, but, according to AstraZeneca, there was a trend favoring Tagrisso-chemotherapy.
"The FLAURA2 results reinforce Tagrisso as a backbone of standard-of-care in first-line EGFR-mutated non-small cell lung cancer, providing patients with an additional nine months of median progression-free survival when combined with chemotherapy," Susan Galbraith, executive VP of oncology R&D at AstraZeneca, said in a statement. "We look forward to working with the FDA on an accelerated timeline to bring this treatment regimen to patients as quickly as possible."