The FDA has come through with a speedy approval for AstraZeneca’s standout cancer drug Tagrisso as a frontline treatment for EGFR-mutated non-small cell lung cancer.
The OK, just four months after the agency offered a priority review, marks another big step forward toward AstraZeneca’s goal of gaining a larger share of the blockbuster lung cancer market. They recently snagged a pioneering approval for their PD-L1 drug durvalumab in stage III unresectable lung cancer, giving them an edge for a large group of patients in a lucrative niche that could remain theirs for some time. Their combination of durvalumab and tremelimumab in frontline lung cancer, though, failed the first hurdle on progression-free survival.
Tagrisso was approved today after researchers demonstrated a median progression-free survival rate of 18.9 months in frontline EGFR-mutated lung cancer, compared to only 10.2 months for the best standard of care.
The approval signals an open door to a much larger market. The drug has been limited to second-line patients with EGFR T790M mutation. And company execs have talked up plans to boost revenue toward the $3 billion mark.
“Today’s FDA approval of Tagrisso in the 1st-line setting is an exciting milestone for patients and our company,” said Dave Fredrickson, AstraZeneca’s EVP of their oncology business. “Tagrisso delivered unprecedented median progression-free survival data across all pre-specified patient subgroups, including patients with or without CNS metastases, and could prolong the lives of more patients without their tumours growing or spreading.”
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 44,100+ biopharma pros who read Endpoints News by email every day.Free Subscription