Expanded Lung Cancer Claim For Lilly’s Cyramza Faces US FDA Scrutiny
Oncologic Drugs Advisory Committee will consider whether a statistically significant benefit on progression-free survival, but no survival advantage, is enough to secure a first-line lung cancer indication for ramucirumab.
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Lilly included progression-free survival 2 as an exploratory endpoint in RELAY on the advice of the European Medicines Agency and says study results show continuing benefit from first-line ramucirumab even after progression; FDA says endpoint is not valid for regulatory purposes and is subject to confounding.
Lilly is positioning the ramucirumab/erlotinib combination as a first-line alternative for EGFR-positive non-small cell lung cancer that preserves AstraZeneca’s Tagrisso for second-line use; advisory committee members vote 6-5 for expanded indication but express skepticism about adoption.
Oncologic Drugs Advisory Committee votes 6-5 that ramucirumab’s benefit/risk profile is favorable in first-line lung cancer, but 13-2 that pivotal trial data do not support approval of Steba’s vascular-targeted, photodynamic therapy for low-risk prostate cancer.