FDA Approvals : Episode 6


FDA Approval of Frontline Osimertinib in Frontline EGFR-Mutant NSCLC

Hello and welcome to OncLive News Network, Breaking News. I'm Gina Columbus.

The FDA has granted an approval to osimertinib as a first-line treatment for patients with non-small cell lung cancer whose tumors harbor EGFR mutations with exon 19 deletions or exon 21 L858R substitution mutations.

The decision is based on findings of the phase III FLAURA study, in which frontline osimertinib reduced the risk of progression or death by 54% versus standard tyrosine kinase inhibitor erlotinib or gefitinib.

In the double-blind study, the median progression-free survival was 10.2 months for standard therapy and 18.9 months with osimertinib.

The PFS benefit with osimertinib extended across all prespecified subgroups. In patients with CNS metastases, the median PFS with osimertinib was 15.2 months versus 9.6 months with standard therapy.

The objective response rate with osimertinib was 80% versus 76% for erlotinib and gefitinib. The median duration of response with osimertinib was 17.2 months versus 8.5 months in the comparator arm.

For more breaking news, subscribe to email alerts from OncLive.com. Thank you for watching! I'm Gina Columbus.

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