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Latest From Sue Sutter
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.
Agency’s clinical experts favor granting access under regulations intended for investigational drugs but ‘lawyers want consistency under the law,’ FDA’s Woodcock says; use of the expanded access pathway for approved agents is generally unnecessary but may provide sponsors with some regulatory cover, external experts say.
US FDA declined stakeholder requests to remove recommendation for placebo controls from a final guidance but added qualifying language on their use ‘when feasible.’ While the agency excised language on biomarker validation from the final guidance, it reaffirmed the need for early establishment of critical quality attributes and critical process parameters.
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.
Sponsor seeks accelerated approval for low-risk, early-stage prostate cancer based on a trial that met its coprimary endpoints, but agency says interpretation of those results is complicated by novelty of the outcomes, data quality issues and increase in genitourinary adverse events.