Latest From Sue Sutter
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.
Twenty accelerated approval indications have been voluntarily withdrawn by sponsors since December 2020, most coming as a result of the FDA cancer office’s push to rid labeling of ‘dangling’ and ‘delinquent’ indications that lack confirmation of clinical benefit.
Even before a new law granted FDA authority to require studies be underway before accelerated approval, review divisions have, in some cases, given sponsors years of advance notice on expectations around study timing, according to a Pink Sheet review of NME accelerated approvals.
A Greater Power: US FDA May Become More Insistent On Timing Of Accelerated Approval Confirmatory Trials
Bolstered by new statutory authority and the Oncology Center of Excellence’s experience in pushing for early initiation of confirmatory trials, review divisions may take a tougher line with sponsors on the design and timing of studies to verify clinical benefit.
But company says the 9 March advisory committee meeting ‘currently does not have any impact’ on Polivy’s existing accelerated approval indication in the third-line setting; agency may be seeking input on the robustness of the progression-free survival benefit and uncertainties about overall survival data in the POLARIX Phase III trial in previously untreated DLBCL.
Use should be targeted for patients with candidemia/invasive candidiasis who require longer-term therapy and for whom daily intravenous administration with currently approved echinocandins is problematic, Antimicrobial Drugs Advisory Committee says.