Farydak®

What is Farydak?

Farydak®, also known as panobinostat, is the first approved myeloma therapy in a class of medicines known as histone deacetylase inhibitors. Farydak was developed by Novartis Pharmaceuticals Corporation. In 2019 Secura Bio acquired the world-wide rights to Farydak.

The MMRF and it’s affiliate organization, the Multiple Myeloma Research Consortium (MMRC), played an integral role in the development of Farydak.


How is Farydak used in multiple myeloma?

In the United States, Farydak is approved by the Food and Drug Administration (FDA) in combination with Velcade (bortezomib, Takeda Oncology) and dexamethasone. It is used for patients who have already received at least two other treatments, including Velcade and an immunomodulatory agent (IMiD), such as Revlimid (lenalidomide, Celgene), Thalomid (thalidomide, Celgene), or Pomalyst (pomalidomide, Celgene), and whose disease has progressed while on their last therapy.

What types of patients can benefit from Farydak therapy?
Farydak has been shown to be effective in patients with relapsed and refractory myeloma following treatment with other available agents, including those who have received a stem cell transplant. Farydak was also shown to have activity in patients with high-risk disease.

How does Farydak work?

Farydak is a histone deacetylase inhibitor. It inhibits multiple enzymes that cancer cells need to grow and survive. Farydak appears to act synergistically with other anti-myeloma drugs, that is, combining the drugs is more effective than either one alone. Farydak also inhibits the growth of new blood vessels needed for tumors to grow.


How is Farydak Administered?

Farydak is an oral medication. Farydak capsules should be taken once on each scheduled day at about the same time, along with a full glass of water. Farydak can be taken with or without food.

Farydak is taken along with Velcade (given as a subcutaneous injection or intravenous infusion) and oral dexamethasone. The recommended starting dose of Farydak is 20 mg, taken once every other day for 3 doses per week, in Weeks 1 and 2 of each 21-day cycle. Patients are typically treated up to 8 cycles. Patients who are clinically benefitting from treatment and are not experiencing severe side effects can receive continued treatment for an additional 8 cycles.

While taking Farydak, patients should avoid star fruit, pomegranate or pomegranate juice, and grapefruit or grapefruit juice because these foods can affect the amount of Farydak in the blood.


What are Farydak side effects?

Farydak side effects vary from patient to patient and may be influenced by the current stage of a patient’s myeloma.

The most common possible side effects of Farydak include:

  • Low red blood cells, white blood cells, or platelets (anemia, neutropenia, leukopenia, lymphopenia, thrombocytopenia)
  • Abnormal blood chemistry including:
    • Increased blood creatinine
    • Low potassium
    • Low or high phosphate
    • Low sodium
    • High bilirubin
    • Low calcium
    • Low albumin
    • High magnesium
  • Diarrhea
  • Fatigue
  • Nausea
  • Swelling in the arms or legs (peripheral edema)
  • Decreased appetite
  • Fever
  • Vomiting

Serious side effects that have been reported with Farydak include:

  • Diarrhea
  • Heart toxicity, including reduced blood flow to the heart, severe heart rhythm disturbances, and electrocardiogram changes
  • Nausea
  • Vomiting
  • Fatigue
  • Low red blood cells, white blood cells, or platelets (anemia, neutropenia, leukopenia, lymphopenia, thrombocytopenia)
  • Bleeding in the lungs or gastrointestinal tract
  • Infection
  • Liver problems (hepatotoxicity)
  • Fetal harm
  • Abnormal blood chemistry including:
    • Low potassium
    • Low phosphate
    • Low sodium
    • Low calcium
    • High magnesium

How are side effects of Farydak managed?

Patients receiving Farydak are monitored carefully for side effects and have periodic blood tests performed. Side effects of Farydak can often be managed with other medications, by increasing the amount of fluids, reducing the dose of Farydak, or stopping Farydak treatment temporarily until symptoms resolve.

Because of the risk of harm to an unborn baby, women should take steps to avoid becoming pregnant while taking Farydak. Women should use effective birth control during treatment with Farydak and for 1 month after stopping treatment. Men should use a condom during treatment with Farydak and for 3 months after stopping treatment.


What have Farydak clinical studies shown?

In a Phase 3 trial known as PANORAMA 1, the combination of Farydak, Velcade, and dexamethasone extended survival over that seen with Velcade and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma.

  • The study included 768 patients who had received 1 to 3 previous lines of therapy and were not refractory to Velcade.
  • Time to disease progression was significantly longer in the Farydak-Velcade-dexamethasone group than the Velcade-dexamethasone group (12.0 months vs 8.1 months) reflecting a 37% reduction in the risk of disease progression or death.
    • Among patients who had previously received both Velcade and an IMiD and an average of 2 prior therapies, time to disease progression was 10.6 months in the Farydak-Velcade-dexamethasone group versus 5.8 months in the Velcade-dexamethasone group, reflecting a 48% reduction in the risk of disease progression or death. The approval of Farydak was based on the efficacy and safety in this more heavily pretreated patient subgroup.
    • In the heavily pretreated patient subgroup, an overall response rate of 59% was seen and more patients receiving the 3-drug combination achieved a complete or near complete response compared with Velcade-dexamethasone (22% vs 9%).
  • The most common side effects included low platelet counts, low white blood cell counts, diarrhea, low red blood cell counts, peripheral neuropathy, and fatigue.
  • Low platelet count was also the most common serious side effect, and was managed with dose reduction and/or interruption.

Long-term follow-up of earlier trials evaluating the Farydak-Velcade-dexamethasone combination shows that continuing Farydak alone or in combination with dexamethasone as maintenance therapy may help to keep the disease under control and to prolong the time to progression in some patients. [Ocio Haematologica 2015]

How is Farydak currently being studied in myeloma?

Farydak is being evaluated in combination with Kyprolis (carfilzomib, Amgen) in previously treated myeloma.

Interested in learning more about Farydak clinical trials? Talk to an MMRF Nurse Patient Navigator to learn more or use our clinical trials finder:

FIND CLINICAL TRIALS

Updated April 2019

Please visit the sponsor’s official patient site for up-to-date information on Farydak