/02/2015 13:42:00
Nov 14: FDA extends its review period by 3 months, moving its decision deadline from December to March [19].
27/11/2014 15:58:34
Nov 14: FDA Oncologic Drugs Advisory Committee vote 5-2 against panobinostat for patients with previously treated MM when used in combination with bortezomib and dexamethasone [18].
07/11/2014 16:31:18
Nov 14: Ahead of an advisory FDA committee meeting, FDA reviewers note that PFS results from many patients in the panobinostat arm of a PIII trial were censored due to incomplete and missing assessments. Factoring in all the omitted data, median PFS extension was 2.2 months vs. placebo; median overall survival median was 33.6 months vs. 30.4 months with placebo [17].
07/11/2014 15:44:08
Jun 14: Filed in the EU under the centralised procedure [15].
01/07/2014 16:52:42
Apr 14: Filed in the US in March 14 [14].
18/06/2014 15:00:01
Apr 14: EU application has not yet been filed [12].
01/05/2014 11:11:50
Jan 14: EU application has not yet been filed [11].
01/05/2014 11:10:48
Oct 13: Filings now planned for 2014 [9].
09/12/2013 12:06:53
Oct 13: EU filing will be via the centralised procedure [10].
09/12/2013 12:01:56
Dec 12: Orphan designation (EU/3/12/1063) granted in the EU for the treatment of multiple myeloma [7].
14/12/2012 12:20:05
Sep 12: Granted orphan drug status in the US for MM [6].
18/09/2012 10:28:05
Aug 11: Filing planned for 2013 [5].
16/08/2011 10:54:08
Filing planned for 2013 onwards [3].
22/03/2010 13:32:10
PIII study started Dec 09 [1].
12/12/2009 22:50:32
Trial or other data
Sep 15: In DRAFT guidance, NICE does not recommend use of panobinostat, in combination with bortezomib and dexamethasone, for treatment of adults with relapsed and/or refractory multiple myeloma who have received 2 or more prior regimens including bortezomib and an immunomodulatory agent [23].
16/09/2015 14:26:21
Sep 14: PANORAMA-1 study published in The Lancet Oncology (n=768). Median follow-up was 6·47 months (IQR 1·81—13·47) in the panobinostat group and 5·59 months (2·14—11·30) in the placebo group. Median progression-free survival was significantly longer in the panobinostat group than in the placebo group (11·99 months [95% CI 10·33—12·94] vs 8·08 months [7·56—9·23]; hazard ratio [HR] 0·63, 95% CI 0·52—0·76; p<0·0001). Overall survival data are not yet mature, although at the time of this analysis, median overall survival was 33·64 months (95% CI 31·34—not estimable) for the panobinostat group and 30·39 months (26·87—not estimable) for the placebo group (HR 0·87, 95% CI 0·69—1·10; p=0·26). The proportion of patients achieving an overall response did not differ between treatment groups (235 [60·7%, 95% CI 55·7—65·6] for panobinostat vs 208 [54·6%, 49·4—59·7] for placebo; p=0·09); however, the proportion of patients with a complete or near complete response was significantly higher in the panobinostat group than in the placebo group (107 [27·6%, 95% CI 23·2—32·4] vs 60 [15·7%, 12·2—19· |
