IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
who have used bortezomib in pa tients who im ported the drug for their own use have shown higher in ci -
dence of lung dis or ders amongst Japanese patients than in non-Japanese patients.
In June 2008, Velcade was ap proved for first-line use in MM in the USA: pre vi ously it had re ceived ap -
proval for sec ond-line use in the USA. The phase III VISTA (VELCADE as Ini tial Stan dard Ther apy in MM:
As sess ment with melphalan and prednisolone) trial to test Velcade in com bi na tion with melphalan and
prednisolone in pa tients with newly-di ag nosed MM who are not trans plant can di dates was stopped early
in Sep tem ber 2007 af ter in terim find ings showed that there was sig nif i cant ad van tage for newly di ag -
nosed pa tients. A fil ing for first-line use in MM was sub mit ted in the EU in De cem ber 2007 and this was
rec om mended for ap proval in July 2008. In Sep tem ber 2008, full ap proval was re ceived for use as a
first-line ther apy for MM in com bi na tion with melphelan and pred ni sone. Ap proval for first-line use was
also received in Canada in September 2008.
The US Na tional Com pre hen sive Can cer Net work (NCCN) up dated its MM Guide lines in Oc to ber 2007 to
in clude Velcade in com bi na tion with J&J’s Doxil (pegylated liposomal doxorubicin) as a cat e gory 1 rec -
om men da tion for pa tients with re lapsed/re frac tory MM in the fol low ing clin i cal sit u a tions: pa tients with
pro gres sive dis ease fol low ing allogenic or autologous stem cell trans plant (SCT); pa tients with pri mary
pro gres sive dis ease fol low ing ini tial autologous or allogenic SCT; and non trans plant can di dates with pro -
gres sive or re laps ing dis ease af ter ini tial in duc tion ther apy. This fol lowed the May 2007 FDA ap proval of
Velcade plus Doxil in combination for the treatment of relapsed or refractory MM.
In Oc to ber 2007, the FDA ap proved an ad di tional in di ca tion for Velcade for use in pa tients with im paired
kid ney function.
Li cens ing: In 2003, Ortho Biotech and Janssen Cilag gained rights to Velcade out side the USA from Mil -
len nium (now part of Takeda, Ja pan). The two com pa nies also agreed to col lab o rate on the fur ther de vel -
op ment of Velcade worldwide.
Clin i cal Data: At the 49th An nual Meet ing of the Amer i can So ci ety of He ma tol ogy, held in At lanta in De -
cem ber 2007, Mil len nium pre sented data from the VISTA study, its piv otal 682-pa tient trial for dem on -
strat ing the ef fec tive ness of Velcade as a first-line ther apy for mul ti ple myeloma. Com plete re mis sion
rates of 30-35% were seen with a com bi na tion of Velcade, melphalan and pred ni sone (VcMP), com pared
with 4-5% seen with the stan dard reg i men of melphalan and pred ni sone (MP) alone. The me dian du ra -
tion of re sponse was 24 months for VcMP, ver sus 13 months with MP, while time to dis ease pro gres sion
was 24 months against 17 months. VcMP dem on strated sta tis ti cal sig nif i cance in over all sur vival, with a
40% re duc tion in the risk of death, and me dian sur vival was not reached at 16 months. Dis con tinu a tion
due to ad verse events was low, and sim i lar in both arms. Also at the ASH meet ing, re sults from a
French-led phase III trial in volv ing 482 pa tients re ceiv ing ini tial treat ment for MM pre- and post-trans -
plan ta tion were re leased. It com pared Velcade and dexa meth a sone (VcD) with vincristine, adriamycin
and dexa meth a sone (VAD). As in duc tion ther apy, VcD led to a com plete re mis sion rate of 21%, com -
pared with 8% for VAD. Af ter stem cell trans plan ta tion, 41% of VcD pa tients achieved remission, versus
29% of those given VAD, saving the number of second transplantations required.
At the 43rd An nual Meet ing of the Amer i can So ci ety of Clin i cal On col ogy, held in Chi cago in June 2007,
data were pre sented from the phase II To tal Ther apy 3 study, which used Velcade in a reg i men called
VTD-PACE, also con tain ing tha lid o mide, dexa meth a sone, cisplatin, adriamycin, cyclophosphamide and
etoposide. Two cy cles were given to 303 pa tients be fore and af ter stem cell trans plan ta tion. Lon ger treat -
ment was pro vided with Velcade, tha lid o mide and dexa meth a sone, and then tha lid o mide and dexa meth -
a sone. The re sults were com pared with those from TT2, which in volved 323 pa tients and omit ted
Velcade. In TT3 a com plete re sponse rate of 84% was seen, up from 68% in TT2, and fewer patients
experienced severe adverse effects.
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