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Both Copiktra and Farydak had received accelerated approvals, and the FDA had required confirmatory trials. Secura Bio has determined such trials are not feasible.
Secura Bio has voluntarily withdrawn oncology indications for two of its therapies. The company has withdrawn the U.S. indication of Copiktra (duvelisib) for the treatment of patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies.
The relapsed or refractory FL indication received accelerated approval in September 2018 with the requirement that an additional confirmatory trial be conducted in order for the product to be granted full approval.
Company officials stressed this is a business decision and is not related to any changes in either the efficacy or safety associated with the therapy but with the logistics, cost and timing of the postmarketing requirements.
This decision impacts only the relapsed or refractory follicular lymphoma indication and does not affect other approved indications in the United States and other countries, including the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior therapies.
Copiktra is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first FDA-approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant cells.
In addition, Secura Bio has withdrawn the NDA approval of Farydak (panobinostat) oral capsules, which received accelerated approval in February 2015 for use in combination with bortezomib and dexamethasone to treat patients with multiple myeloma who have received at least two prior regimens. Secura Bio acquired the therapy in March 2019.
The accelerated approval was based on progression-free survival and consistent with FDA regulations, required further adequate and well-controlled clinical studies to verify and describe the product's clinical benefit. In its withdrawal submission, Secura Bio noted that, as previously discussed with FDA, it was not feasible for the company to complete the required post-approval clinical studies as designed as part of the accelerated approval process.
Secura Bio and its partners will continue to market Farydak in other markets where it has been approved.