publication date: Feb. 27, 2015

Accelerated Approval Granted to Farydak in Multiple Myeloma

 

FDA granted accelerated approval to Farydak (panobinostat) for the treatment of multiple myeloma. The FDA had previously granted Farydak priority review and an orphan product designation.

Farydak inhibits the activity of histone deacetylases. This process 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 to 5.8 months in participants treated with bortezomib and dexamethasone alone. Additionally, 59 percent of Farydak-treated participants saw their cancer shrink or disappear after treatment, versus 41 percent in those receiving bortezomib and dexamethasone.

Continue reading 41-08 Accelerated Approval Granted to Farydak in Multiple Myeloma

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