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

Saturday, June 21, 2008 General News
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CAMBRIDGE, Mass. and OSAKA, Japan, June 20 MillenniumPharmaceuticals, The Takeda Oncology Company, and Takeda PharmaceuticalCompany Limited ("Takeda", TSE: 4502) today announced that the U.S. Food andDrug Administration (FDA) approved VELCADE for patients with previouslyuntreated multiple myeloma (MM). The Company's co-development partner, Johnson& Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) also hasfiled a corresponding application with the European Medicines EvaluationAgency (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 survivalbenefit," said Paul Richardson, M.D., a senior investigator for the study andClinical Director of the Jerome Lipper Multiple Myeloma Center at Dana-FarberCancer Institute.

"We are excited for patients with previously untreated multiple myeloma,who now can benefit from VELCADE, including its ability to deliver asignificant increase in overall survival. VELCADE treatment also is availablefor multiple myeloma patients in the second- and third-line settings, where italready 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, openlabel, active-control trial in previously untreated patients with symptomaticmultiple myeloma. Patients were randomized to receive either nine 6 weekcycles of oral melphalan (M) plus prednisone (P) or MP plus VELCADE. Patientsreceived M (9 mg/m2) plus P (60 mg/m2) daily for four days every 6 weeks orthe 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 weekson 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 secondaryendpoints. A total of 682 patients were randomized: 338 to receive MP and 344to receive the combination of bortezomib plus MP. The median age of patientsfor both groups was 71 years. Demographics and baseline diseasecharacteristics were similar between the two groups.

The safety profile of VELCADE in combination with MP is consistent withthe known safety profiles of both VELCADE and MP.

In VISTA, the most commonly reported adverse events for VELCADE incombination with MP vs MP, respectively, were thrombocytopenia (52% vs 47%),neutropenia (49% vs 46%), nausea (48% vs 28%), peripheral neuropathy (47% vs5%), 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% vs10%), asthenia (21% vs 18%), cough (21% vs 13%), insomnia (20% vs 13%), edemaperipheral (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% vs10%), 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 withmultiple myeloma. VELCADE also is indicated for

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