- New indication offers earlier treatment options for patients -
CAMBRIDGE, Mass. and OSAKA, Japan, June 20 /PRNewswire/ -- Millennium
Pharmaceuticals, The Takeda Oncology Company, and Takeda Pharmaceutical
Company Limited ("Takeda", TSE: 4502) today announced that the U.S. Food
and Drug Administration (FDA) approved VELCADE for patients with previously
untreated multiple myeloma (MM). The Company's co-development partner,
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD)
also has filed a corresponding application with the European Medicines
Evaluation Agency (EMEA).
(Logo: http://www.newscom.com/cgi-bin/prnh/20080620/NEF058LOGO-a )
(Logo: http://www.newscom.com/cgi-bin/prnh/20080620/NEF058LOGO-b )
"This comes as wonderful news for patients. The VISTA(1) trial showed
30% complete remission rate with bortezomib compared to 4% for the control
arm. Importantly, patients treated with bortezomib also experienced a
survival benefit," said Paul Richardson, M.D., a senior investigator for
the study and Clinical Director of the Jerome Lipper Multiple Myeloma
Center at Dana-Farber Cancer Institute.
"We are excited for patients with previously untreated multiple
myeloma, who now can benefit from VELCADE, including its ability to deliver
a significant increase in overall survival. VELCADE treatment also is
available for multiple myeloma patients in the second- and third-line
settings, where it already is approved," said Deborah Dunsire, M.D.,
President and CEO, Millennium Pharmaceuticals, The Takeda Oncology Company.
The current approval was based on an international, multicenter, open
label, active-control trial in previously untreated patients with
symptomatic multiple myeloma. Patients were randomized to receive either
nine 6 week cycles of oral melphalan (M) plus prednisone (P) or MP plus
VELCADE. Patients received M (9 mg/m2) plus P (60 mg/m2) daily for four
days every 6 weeks or the same MP schedule with bortezomib (1.3 mg/m2) IV
on days 1, 4, 8, 11, 22, 25, 29 and 32 of every 6 week cycle for 4 cycles
then once weekly for 4 weeks on days 1, 8, 22 and 29 of every 6 week cycle
for 5 additional cycles. Antiviral prophylaxis was recommended for patients
on the VELCADE study arm. Time-to-progression (TTP) was the primary
efficacy endpoint. Overall survival (OS), progression-free survival (PFS)
and response rate (RR) were secondary endpoints. A total of 682 patients
were randomized: 338 to receive MP and 344 to receive the combination of
bortezomib plus MP. The median age of patients for both groups was 71
years. Demographics and baseline disease characteristics were similar
between the two groups.
The safety profile of VELCADE in combination with MP is consistent with
the known safety profiles of both VELCADE and MP.
In VISTA, the most commonly reported adverse events for VELCADE in
combination with MP vs MP, respectively, were thrombocytopenia (52% vs
47%), neutropenia (49% vs 46%), nausea (48% vs 28%), peripheral neuropathy
(47% vs 5%), diarrhea (46% vs 17%), anemia (43% vs 55%), constipation (37%
vs 16%), neuralgia (36% vs 1%), leukopenia (33% vs 30%), vomiting (33% vs
16%), pyrexia (29% vs 19%), fatigue (29% vs 26%), lymphopenia (24% vs 17%),
anorexia (23% vs 10%), asthenia (21% vs 18%), cough (21% vs 13%), insomnia
(20% vs 13%), edema peripheral (20% vs 10%), rash (19% vs 7%), back pain
(17% vs 18%), pneumonia (16% vs 11%), dizziness (16% vs 11%), dyspnea (15%
vs 13%), headache (14% vs 10%), pain in extremity (14% vs 9%), abdominal
pain (14% vs 7%), paresthesia (13% vs 4%), herpes zoster (13% vs 4%),
bronchitis (13% vs 8%), hypokalemia (13% vs 7%), hypertension (13% vs 7%),
abdominal pain upper (12% vs 9%), hypotension (12% vs 3%), dyspepsia (11%
vs 7%), nasopharyngitis (11% vs 8%), bone pain (11% vs 10%), arthralgia
(11% vs 15%) and pruritus (10% vs 5%).
Important Safety Information
In the U.S., VELCADE is indicated for the treatment of patients with
multiple myeloma. VELCADE also is indicated for the treatment of patients
with mantle cell lymphoma who have received at least one prior therapy.
VELCADE is contraindicated in patients with hypersensitivity to bortezomib,
boron or mannitol. VELCADE should be administered under the supervision of
a physician experienced in the use of antineoplastic therapy.
Risks associated with VELCADE therapy include new or worsening
peripheral neuropathy, hypotension throughout therapy, cardiac and
pulmonary disorders, reversible posterior leukoencephalopathy syndrome,
gastrointestinal adverse events, thrombocytopenia, neutropenia, tumor lysis
syndrome and hepatic events. Women of childbearing potential should avoid
becoming pregnant while being treated with VELCADE. Nursing mothers are
advised not to breastfeed while receiving VELCADE. Cases of severe sensory
and motor peripheral neuropathy have been reported. The long-term outcome
of peripheral neuropathy has not been studied in mantle cell lymphoma.
Acute development or exacerbation of congestive heart failure, and new
onset of decreased left ventricular ejection fraction has been reported,
including reports in patients with no risk factors for decreased left
ventricular ejection fraction. There have been reports of acute diffuse
infiltrative pulmonary disease of unknown etiology such as pneumonitis,
interstitial pneumonia, lung infiltration and Acute Respiratory Distress
Syndrome in patients receiving VELCADE. Some of these events have been
fatal. There have been reports of Reversible Posterior Leukoencephalopathy
Syndrome (RPLS) in patients receiving VELCADE. RPLS is a rare, reversible,
neurological disorder which can present with seizure, hypertension,
headache, lethargy, confusion, blindness, and other visual and neurological
disturbances. VELCADE is associated with thrombocytopenia and neutropenia.
There have been reports of gastrointestinal and intracerebral hemorrhage in
association with VELCADE. Transfusions may be considered. Complete blood
counts (CBC) should be frequently monitored during treatment with VELCADE.
Cases of acute liver failure have been reported in patients receiving
multiple concomitant medications and with serious underlying medical
conditions. Patients who are concomitantly receiving VELCADE and drugs that
are inhibitors or inducers of cytochrome P450 3A4 should be closely
monitored for either toxicities or reduced efficacy. Patients on oral
antidiabetic medication while receiving VELCADE should check blood sugar
levels frequently.
Adverse Reaction Data
Safety data from Phase II and III studies of single-agent VELCADE 1.3
mg/m2/dose twice weekly for 2 weeks followed by a 10-day rest period in
1163 patients with previously treated multiple myeloma (N=1008, not
including the Phase III, VELCADE plus DOXIL(R) [doxorubicin HCl liposome
injection] study) and previously treated mantle cell lymphoma (N=155) were
integrated and tabulated. In these studies, the safety profile of VELCADE
was similar in patients with multiple myeloma and mantle cell lymphoma.
In the integrated analysis, the most commonly reported adverse events
were asthenic conditions (including fatigue, malaise and weakness) (64%),
nausea (55%), diarrhea (52%), constipation (41%), peripheral neuropathy NEC
(including peripheral sensory neuropathy and peripheral neuropathy
aggravated) (39%), thrombocytopenia and appetite decreased (including
anorexia) (each 36%), pyrexia (34%), vomiting (33%), anemia (29%), edema
(23%), headache, paresthesia and dysesthesia and headache (each 22%),
dyspnea (21%), cough and insomnia (each 20%), rash (18%), arthralgia (17%),
neutropenia and dizziness (excluding vertigo) (each 17%), pain in limb and
abdominal pain (each 15%), bone pain (14%), back pain and hypotension (each
13%), herpes zoster, nasopharyngitis, upper respiratory tract infection,
myalgia and pneumonia (each 12%), muscle cramps (11%), and dehydration and
anxiety (each 10%). Twenty percent (20%) of patients experienced at least 1
episode of greater than or equal to Grade 4 toxicity, most commonly
thrombocytopenia (5%) and neutropenia (3%). A total of 50% of patients
experienced serious adverse events (SAEs) during the studies. The most
commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea
(5%), vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia
(each 3%).
About Multiple Myeloma
Multiple myeloma is the second most common hematological malignancy.
Between 2001 - 2005, the median age of diagnosis was 70 years. On January
1, 2005 in the U.S., there were approximately 56,200 individuals living
with multiple myeloma.
About VELCADE
VELCADE is being co-developed by Millennium Pharmaceuticals, The Takeda
Oncology Company, and Johnson & Johnson Pharmaceutical Research &
Development, L.L.C. Millennium is responsible for commercialization of
VELCADE in the U.S. and Janssen-Cilag is responsible for commercialization
in Europe and the rest of the world. Janssen Pharmaceutical K.K. is
responsible for commercialization in Japan. For a limited period of time,
Millennium and Ortho Biotech Inc. are co-promoting VELCADE in the U.S. For
more information about VELCADE clinical trials, patients and physicians can
contact the Millennium Medical Product Information Department at
1-866-VELCADE (1-866-835-2233).
About Millennium
Millennium Pharmaceuticals, The Takeda Oncology Company, is a leading
biopharmaceutical company based in Cambridge, Mass. that markets VELCADE, a
cancer product, and has a robust clinical development pipeline of product
candidates. The research, development and commercialization activities at
Millennium are focused in oncology. By applying its knowledge of the human
genome, understanding of disease mechanisms and industrialized drug
discovery platform, Millennium is developing an exciting pipeline of
innovative product candidates. The Millennium website is
http://www.millennium.com.
About Takeda
Located in Osaka, Japan, Takeda is a research-based global company with
its main focus on pharmaceuticals. As the largest pharmaceutical company in
Japan and one of the global leaders of the industry, Takeda is committed to
striving toward better health for individuals and progress in medicine by
developing superior pharmaceutical products. Additional information about
Takeda is available through its corporate website, http://www.takeda.com.
Editors' Note: This press release is also available under the Media
section of the Company's website at: http://www.millennium.com
Contacts:
Karen Gobler (Millennium) Seizo Masuda (Takeda)
(617) 444-1392 (011-81) 3-3278-2037
karen.gobler@mpi.com masuda_seizo@takeda.co.jp
Jennifer Snyder (Millennium)
(617) 444-1439
jennifer.snyder@mpi.com
(1) VELCADE as Initial Standard Therapy in multiple myeloma: Assessment
with melphalan and prednisone
SOURCE Millennium Pharmaceuticals
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Related links:
http://www.millennium.com
http://www.takeda.com
Photo Notes:http://www.newscom.com/cgi-bin/prnh/20080620/NEF058LOGO-a
http://www.newscom.com/cgi-bin/prnh/20080620/NEF058LOGO-b
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
http://www.prnewswire.com/comp/114562.html /
CONTACT:
Karen Gobler, +1-617-444-1392,
karen.gobler@mpi.com, or Jennifer Snyder, +1-617-444-1439,
jennifer.snyder@mpi.com, both of Millennium Pharmaceuticals, or
Seizo Masuda of Takeda, (011-81) 3-3278-2037,
masuda_seizo@takeda.co.jp
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