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Secura Bio announced that it has decided to withdraw the accelerated approval of the New Drug Application for Farydak® (panobinostat) for use in combination with bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent.
In February 2015, Farydak received accelerated approval for this indication based on progression free survival from a randomized, double-blind, placebo-controlled, multicenter phase 3 study (ClinicalTrials.gov Identifier: NCT01023308). Continued approval required further verification and description of clinical benefit in confirmatory trials.
The decision to withdraw the application was made after the Company noted that “it was not feasible […] to complete the required post-approval clinical studies as designed as part of the accelerated approval process.” As a result, the clinical benefit of Farydak has not been confirmed.
Because of the withdrawal submission, the Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee has cancelled its meeting on December 2, 2021 to discuss the approval of Farydak.
Reference
Secura Bio announces US withdrawal of Farydak® (panobinostat) NDA. News release. Secura Bio, Inc. November 30, 2021. Accessed December 1, 2021. https://www.prnewswire.com/news-releases/secura-bio-announces-us-withdrawal-of-farydak–panobinostat-nda-301434428.html.
