8]; p=0·00006). Minimal responses were noted in 23 (6%) patients in the panobinostat group and in 42 (11%) in the placebo group. Median duration of response (partial response or better) was 13·14 months (95% CI 11·76—14·92) in the panobinostat group and 10·87 months (9·23—11·76) in the placebo group, and median time to response (partial response or better) was 1·51 months (1·41—1·64) in the panobinostat group and 2·00 months (1·61—2·79) in the placebo group [16].
22/09/2014 11:09:13
June 14: Results from P3 PANORAMA-1 study presented at 50th ASCO. There was a 37% improvement in progression-free survival when using panobinostat in combination with bortezomib and dexamethasone vs. treatment with same regimen with placebo (HR=0.63, 95% CI 0.52 to 0.76, p<0.0001). In the panobinostat arm, there was a 4-month prolongation of median PFS (12 months versus 8 months in the placebo arm). [13]
04/06/2014 08:37:59
Dec 13: Top-line results from a PIII trial show panobinostat significantly extended PFS in patients with relapsed or relapsed and refractory MM in combination with bortezomib and dexamethasone, compared with the latter two drugs alone. Full results from the study will be presented at an upcoming medical congress and discussed with regulatory authorities worldwide [8].
06/12/2013 16:38:16
The PII ALPHA-MM study is being conducted by Novartis & the Multiple Myeloma Research Consortium (MMRC). It began recruitment of 144 pts with relapsed or refractory MM from the US, Canada & Europe in Aug 07; pts must have received at least two prior therapies & have disease progression on their most recent therapy. Prior therapy must have included bortezomib or lenalidomide. Safety & efficacy data have been reported; the trial did not meet its objective (≥3 responses in 25 pts) in stage 1 required to proceed to stage 2 [4].
05/04/2011 09:59:02
Jun 10: Novartis initiated the PANORAMA II PII trial (NCT01083602) of panobinostat plus bortezomib & dexamethasone in pts with relapsed MM refractory to bortezomib & have received at least two prior lines of therapy. The trial is designed to eva luate the effectiveness of the combination, and will recruit approx 47 US pts [4].
05/04/2011 09:56:12
NCT01023308 a multinational, randomized, double-blind, placebo-controlled, parallel group PIII study to compare progression-free survival of two combination therapies - panobinostat with bortezomib and dexamethasone or placebo with bortezomib and dexamethasone - in 676 patients with previously treated MM whose disease has recurred or progressed. The study started in Dec 09 and is expected to complete Jun 13 [2].
12/12/2009 22:51:27
Evidence Based eva luations
EPAR http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/003725/WC500193300.pdf
FDA doc http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205353s000lbl.pdf
NICE scope http://www.nice.org.uk/guidance/indevelopment/gid-tag477/documents
NHSC/NIHR http://www.hsc.nihr.ac.uk/topics/panobinostat-faridak-for-relapsed-or-refractory-mu/
References
Available only to registered users
Category
BNF Category: Other antineoplastic drugs (08.01.05)
Pharmacology: First-in-class pan-deace |
