WARNING: FATAL AND SERIOUS TOXICITIES: SEVERE DIARRHEA AND CARDIAC TOXICITIES
Severe diarrhea occurred in 25% of FARYDAK treated patients. Monitor for symptoms, institute anti-diarrheal treatment...+
FARYDAK® (panobinostat) capsules was studied in a clinical trial of 768 adult patients who had received 1 to 3 lines of prior therapy.1
The approval of FARYDAK was based upon the efficacy and safety in a prespecified subgroup analysis of 193 patients who had received prior treatment with both bortezomib (BTZ) and an immunomodulatory drug (IMiD) and a median of 2 prior therapies, as the benefit:risk appeared to be greater in this more heavily pretreated population than in the overall trial population.1
PANORAMA-1 study design: Randomized, double-blind, placebo-controlled, phase 3 study2
BTZ = bortezomib; Dex = Dexamethasone; IMiD = immunomodulatory drug; PANORAMA = PANobinostat ORAl in multiple MyelomA.
Primary end point: progression-free survival (PFS)1,c
Selected secondary end points: overall survival (OS), complete response/near-complete response (CR/nCR) rate, time to response, time to progression, duration of response, and safety2,d
aPatients had measurable disease at screening, defined by serum M-protein of ≥1 g/dL or urine M-protein of ≥200 mg/24 h. BTZ-refractory patients were excluded.3
bFARYDAK 20 mg was taken once a day, 3 times per week, on a 2-weeks-on, 1-week-off dosing regimen, in combination with intravenous (IV) BTZ 1.3 mg/m2, 2 times per week in the first treatment part and once a week in the second treatment part, and dex 20 mg was taken 4 times per week in the first treatment part and 2 times a week in the second treatment part.3
Patient characteristics at baseline: patients previously treated with BTZ and IMiDs4
ISS = International Staging System.
83% improvement in median progression-free survival (PFS) with FVD combination therapy1,3
Kaplan-Meier plot of PFS in patients with multiple myeloma who received prior treatment with both BTZ and an IMiD1
The median duration of exposure to study treatment was 5 months, with 16% of patients exposed to study treatment for ≥48 weeks1
The median duration of follow-up was 29 months in both arms
FARYDAK is the first and only HDAC inhibitor approved in relapsed multiple myeloma1
Accelerated approval of FARYDAK based on PFS1
Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials1
FARYDAK was studied in PANORAMA 1, a phase 3, randomized, double-blind study (N=768) in patients with relapsed multiple myeloma who had received 1 to 3 lines of prior therapy. Patients were randomized to receive either FARYDAK or placebo with BTZ and dex. The prespecified subgroup of patients who received prior BTZ and IMiDs in any line represents 25.1% (n=193) of the study population (94 patients in the FVD arm and 99 patients in the placebo/BTZ/dex arm). The primary end point was PFS, and selected secondary end points were CR/nCR rate, time to response, time to progression, response duration, and safety.1
IMPORTANT SAFETY INFORMATION
Severe diarrhea occurred in 25% of FARYDAK treated patients. Monitor for symptoms, institute anti-diarrheal treatment, interrupt FARYDAK and then reduce dose or discontinue FARYDAK.
Severe and fatal cardiac ischemic events, severe arrhythmias, and ECG changes have occurred in patients receiving FARYDAK. Arrhythmias may be exacerbated by electrolyte abnormalities. Obtain ECG and electrolytes at baseline and periodically during treatment as clinically indicated.
For patients in PANORAMA-1 who received 2 prior regimens1,2
More than DOUBLE complete response rate (CR/nCR)d with FVD1,3
Treatment with FVD was associated with higher overall response rates compared with placebo/BTZ/dex (59% [CI: 47.9, 68.6] vs 41% [CI: 31.6, 51.8], respectively)1
cAs per modified European Bone Marrow Transplant Group (mEBMT) criteria and as assessed by the investigator.1
dCR was defined as absence of M-protein in serum and urine by immunofixation for ≥6 weeks, <5% plasma cells in bone marrow, no increase in size or number of lytic bone lesions from baseline, and disappearance of soft tissue plasmacytomas (if present at baseline). All CR criteria apply to nCR, except that absence of serum and urine M-protein could not be confirmed by immunofixation.4
1. FARYDAK [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2016. 2. San-Miguel JF, Hungria VT, Yoon SS, et al. Panobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: a multicentre, randomised, double-blind phase 3 trial. Lancet Oncol. 2014;15(11):1195-1206. 3. Data on file. Clinical study report CLBH589D2308. Novartis Pharmaceuticals Corp; Feb 2014. 4. Data on file. Subpopulation report CLBH589D2308. Novartis Pharmaceuticals Corp; 2014. 5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V.3.2016. © 2016 National Comprehensive Cancer Network, Inc. All rights reserved. Accessed August 31, 2016. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc.
FARYDAK® (panobinostat) capsules, a histone deacetylase inhibitor, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
IMPORTANT SAFETY INFORMATION