Cyramza First-Line Lung Cancer Bid Raises Clinical Practice Questions
Lilly Drug Wins Narrow FDA Advisory Committee Backing
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.
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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.
Studied with Tarceva, Cyramza showed an ability to improve PFS in patients with EGFR-mutant tumors. But how will a two-company combo fare against Tagrisso monotherapy?
Experience and data from the study, which will use the same vector platform to deliver different transgenes for different diseases, could feed into the US FDA’s efforts to establish a public-private partnership to enable manufacturing of gene therapies for ultra-rare diseases.