Farydak (panobinostat) is an oral cancer medication that’s approved by the U.S. Food and Drug Administration (FDA) to treat relapsed or refractory myeloma patients who have already been treated with Velcade (bortezomib) and an immunomodulatory treatment such as Revlimid (lenalidomide) or Thalomid (thalidomide). It was originally developed by Novartis and later bought in March 2019 by Secure Bio.

The treatment belongs to the class of histone deacetylase inhibitors and is used in combination with Velcade and dexamethasone.

How does Farydak work?

Farydak works by inhibiting the action of histone deacetylases (HDACs), which are abundant in myeloma cells.

HDACs are enzymes that remove acetyl groups from histone proteins, altering the interaction between histone proteins and DNA. This subsequently inhibits the activity of many genes involved in controlling cell growth and multiplication. HDACs also play an important role in the removal of waste proteins from the cell.

By inhibiting HDACs, Farydak is thought to interfere with the ability of myeloma cells to multiply and remove waste proteins, resulting in the inhibition of cancer cell growth.

Farydak in clinical trials

A multicenter, randomized, placebo-controlled Phase 3 trial (NCT01023308) called PANORAMA-1 compared the combination of Velcade and dexamethasone with or without Farydak in a subgroup of 193 myeloma patients who had received at least two prior treatments, including Velcade and an immunomodulatory treatment such as Revlimid.

The results from the study showed that patients who received Farydak lived longer (10.6 months on average) without their myeloma worsening compared to the patients who did not receive Farydak (5.8 months on average). Furthermore, the cancer disappeared or shrunk in about 59% of patients who received Farydak compared with 41% of those who did not receive Farydak.

Based on these results, Farydak received FDA’s accelerated approval in February 2015 for myeloma patients who had received two prior treatments, including Velcade and an immunomodulatory treatment.

A multicenter, randomized, open-label Phase 2 trial (NCT02654990) called PANORAMA-3 is currently evaluating the efficacy of lower doses of Farydak with under-the-skin Velcade and dexamethasone in 249 patients with relapsed or refractory myeloma who have already received an immunomodulatory treatment. The study is expected to be completed in 2023.

Other clinical trials are studying the efficacy of Farydak in combination with other approved treatments for the treatment of myeloma patients:

A Phase 2 trial (NCT03256045) in Washington is currently recruiting for about 40 patients with relapsed or refractory multiple myeloma to study the efficacy of a combination treatment of Farydak, Kyprolis (carfilzomib), and dexamethasone. The study is expected to end in 2024.

A Phase 1/2 trial (NCT01496118) is evaluating the effect of a combination of Farydak and Kyprolis in patients with relapsed or refractory multiple myeloma.

A Phase 1 trial (NCT01965353) aims to evaluate the effect of a combination of Farydak with Revlimid, Velcade, and dexamethasone as a possible treatment for patients with relapsed or refractory myeloma.

A Phase 1/2 trial (NCT00918333) is studying the combination of Farydak and the chemotherapy agent Afinitor (everolimus) in treating patients with recurrent myeloma.

Other information

Farydak can cause serious side effects including severe diarrhea and serious heart problems. Therefore, it is approved for use only as third-line therapy in patients who failed to respond to two prior treatments.

Other common but less-severe side effects include diarrhea, nausea, weakness, vomiting, swelling, and fever.

 

Last updated: Jan. 15, 2020

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