US FDA Dismisses Post-Progression Endpoint In Cyramza Lung Cancer Study
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.
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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.
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.
Cidara developed the antifungal for candidemia/invasive candidiasis pursuant to the FDA’s 2017 ‘Unmet Need guidance,’ which provides an avenue for approval with a 'limited use' indication based on a streamlined development program. Some of the guidance recommendations also have been leveraged under the LPAD pathway.