What have Farydak clinical studies shown?
In a Phase 3 trial known as PANORAMA 1, the combination of Farydak® (panobinostat, Novartis), Velcade® (bortezomib, Takeda Oncology), 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).
- 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. 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® (panobinostat, Novartis) is being evaluated as part of various combination therapies in ongoing clinical trials in both newly diagnosed and previously treated myeloma.