publication date: Mar. 31, 2015

FDA Grants Accelerated Approval to Farydak For Patients with Multiple Myeloma

 

FDA granted accelerated approval to Farydak (panobinostat) for the treatment of patients with multiple myeloma.

An improvement in survival or disease-related symptoms has not yet been established for Farydak. The drug’s sponsor, Novartis Pharmaceuticals, is required to conduct confirmatory trials to verify and describe the clinical benefit of Farydak. FDA had previously granted Farydak priority review and orphan product designation.

Farydak inhibits histone deacetylases, which may slow the over-development of plasma cells in multiple myeloma patients or cause these cells to die. Farydak is the first HDAC inhibitor approved to treat multiple myeloma.

It is intended for patients who have received at least two prior standard therapies, including bortezomib and an immunomodulatory agent. Farydak is to be used in combination with bortezomib and dexamethasone.

In November 2014, the FDA’s Oncologic Drugs Advisory Committee advised the agency that, based on the data reviewed, the drug’s benefits did not outweigh its risks for patients with relapsed multiple myeloma. After the meeting, the company submitted additional information supporting Farydak’s use for a different indication: patients with multiple myeloma who have received at least two prior standard therapies, including bortezomib and an immunomodulatory agent.

The safety and efficacy of Farydak in combination with bortezomib and dexamethasone was demonstrated in 193 clinical trial participants with multiple myeloma who received at least two prior treatments that included bortezomib and an immunomodulatory agent. Participants were randomly assigned to receive a combination of Farydak, bortezomib and dexamethasone, or bortezomib and dexamethasone alone.

Study results showed participants receiving the Farydak combination saw a delay in their disease progression for about 10.6 months, compared … Continue reading CCL March – FDA Grants Accelerated Approval to Farydak For Patients with Multiple Myeloma

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