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.”
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