Navigation Links
FDA Approves VELCADE(R) (Bortezomib) for Injection for Patients with Previously Untreated Multiple Myeloma

- 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: )

(Logo: )

"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.


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

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,

Editors' Note: This press release is also available under the Media section of the Company's website at:


Karen Gobler (Millennium) Seizo Masuda (Takeda)

(617) 444-1392 (011-81) 3-3278-2037

Jennifer Snyder (Millennium)

(617) 444-1439

(1) VELCADE as Initial Standard Therapy in multiple myeloma: Assessment

with melphalan and prednisone

SOURCE Millennium Pharmaceuticals
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Japan Approves CyberKnife System for Extracranial Use
2. FDA approves NeuRx diaphragm pacing system for use in spinal cord- injured patients
3. FDA Approves Cymbalta(R) for the Management of Fibromyalgia
4. ClearWay Minnesota(SM) Board Approves $1.4 Million in New Grants to Reduce Tobaccos Harm
5. FDA Approves AstraZenecas Seroquel(R) for Maintenance Treatment in Bipolar Disorder
6. FDA Approves NOVO NORDISKs NovoSeven(R) RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable) for Hemophilia Patients With Inhibitors
7. FDA Approves Taclonex Scalp(R) - Once Daily Therapy for Treatment of Moderate to Severe Scalp Psoriasis
8. FDA Approves Health Claim for Brown Rice
9. FDA Approves Strattera(R) for Maintenance of ADHD in Children and Adolescents
10. FDA approves HeartMate II mechanical heart pump for heart-failure patients
11. FDA Approves Advair(R) 250/50 for Reduction of Exacerbations in Patients With COPD
Post Your Comments:
(Date:11/27/2015)... PITTSBURGH, PA (PRWEB) , ... November 27, 2015 ... ... of how filthy the toilets were," said an inventor from Hillside, N.J. "Many ... this improved seat cover so that individuals will always be protected from germs." ...
(Date:11/27/2015)... ... November 27, 2015 , ... Consistent with the ... 2016 Building Better Radiology Marketing Programs meeting will showcase some of the ... 2016, at Caesars Palace in Las Vegas with a pre-conference session on a ...
(Date:11/27/2015)... ... November 27, 2015 , ... CBD College is proud ... Education Programs (CAAHEP) awarded accreditation to its Diagnostic Medical Sonography program. CBD College is ... only one of twelve colleges and universities in the state of California make the ...
(Date:11/26/2015)... ... November 26, 2015 , ... Patients at Serenity Point ... come together on Thanksgiving Day to share the things that they are most ... Serenity Point YouTube channel, patients displayed what they wrote on index cards, describing ...
(Date:11/26/2015)... ... November 26, 2015 , ... Jobs in hospital medical laboratories and in ... by healthcare staffing agency Aureus Medical Group . These fields, as ... among those searching for healthcare jobs through the company’s website, , ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... -- Research and Markets ( ) has ... Horizons and Growth Strategies in the Italian Therapeutic ... Forecasts, Competitive Intelligence, Emerging Opportunities" report to ... --> This new 247-page report provides ... monitoring market, including emerging tests, technologies, instrumentation, sales ...
(Date:11/25/2015)... global healthcare industry is expected to grow at a rate ... has the highest projected growth at 12.7%, and ... is second with growth projected at 11.5%. ... 2013-2014, total government funded healthcare was nearly 68%. Federal government ... 2013-2014. In real terms, out of pocket expenditure increased by ...
(Date:11/25/2015)... , Nov. 25, 2015 AAIPharma ... planned investment of at least $15.8  Million to ... Wilmington, NC . The expansion will ... to meet the growing demands of the pharmaceutical ... site expansion will provide up to 40,000 ...
Breaking Medicine Technology: