FDA Approves Addition of Sustained Overall Survival Advantage (5-year follow-up) to Label for VELCADE® in Patients w

—VELCADE improved median overall survival by 13.3 months when used first in previously untreated multiple myeloma patients—

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited (TSE:4502) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE (bortezomib) for Injection, which updates the label to include additional long-term (median follow-up 60.1 months) overall survival (OS) data from the VISTA trial. The landmark VISTA trial examined the use of VELCADE-based therapy in patients with previously untreated multiple myeloma (MM).

The 5-year follow-up data demonstrated that patients treated with VELCADE, melphalan and prednisone (VcMP) continued to have a statistically significantly longer OS (median OS 56.4 versus 43.1 months, p<0.05) than those treated with melphalan and prednisone (MP) alone, a recognized standard of care. These results translated into a 43.9 percent improvement in OS when patients received the VELCADE containing regimen. A complete data set from the trial will be presented at the upcoming meeting of the American Society of Hematology.

An earlier analysis (median follow-up of 36.7 months), demonstrated that starting with the VELCADE combination (VcMP) provided a statistically significant OS advantage over MP that was not regained despite the use of subsequent therapies including VELCADE-based regimens.

The VISTA trial is the largest Phase III registration study to report long-term OS in previously untreated multiple myeloma patients. This multicenter, international 682-patient clinical trial compared VcMP to MP in patients with previously untreated MM who were not eligible for stem cell transplantation. The safety profile of VELCADE in combination with MP was consistent with the known safety profiles of both VELCADE and MP. This study was conducted by Millennium and its co-development partner Johnson & Johnson Pharmaceutical Research & Development (J&JPRD).

The prescribing information is also being updated to provide the information that the concomitant use of strong CYP3A4 inducers with VELCADE is not recommended.

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%).

About VELCADE

VELCADE is co-developed by Millennium and Ortho Biotech Oncology Research & Development, unit of Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S., Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Takeda Pharmaceutical Company Limited and Janssen Pharmaceutical K.K. co-promote VELCADE in Japan. VELCADE is approved in more than 90 countries and has been used to treat more than 300,000 patients worldwide.

Important Safety Information

VELCADE® (bortezomib) is approved for the treatment of patients with multiple myeloma. VELCADE is also approved for the treatment of patients with mantle cell lymphoma who have already received at least one prior treatment.

Patients should not receive VELCADE if they are allergic to bortezomib, boron or mannitol. Women should be advised not to take VELCADE while pregnant or breast-feeding. Patients with diabetes may require close monitoring and adjustment of their medication.

VELCADE can cause serious side effects, including:

  • Lowering the levels of blood cells, which could result in a higher risk for infections or bleeding.
  • Nausea, vomiting, diarrhea and constipation.
  • Nerve problems, which can be severe including muscle weakness, tingling, burning, pain, or loss of feeling in the hands and feet.
  • A drop in blood pressure resulting in dizziness, light headedness or fainting.
  • Heart rhythm problems and heart failure including worsening of existing conditions. Symptoms may include chest pressure or pain, palpitations, swelling of the ankles or feet, or shortness of breath.
  • Lung disorders, some of which have been fatal. Symptoms include cough, shortness of breath, wheezing or difficulty breathing.
  • Liver failure including a yellow discoloration of the eyes and skin.
  • Tumor Lysis Syndrome and Reversible Posterior Leukoencephalopathy Syndrome have been reported.

Common side effects seen in patients receiving VELCADE include: fever, decreased appetite, fatigue, insomnia and headache.

These are not all of the possible side effects with VELCADE. Please see the full Prescribing Information for VELCADE for a complete list.

Editors’ Note: This press release is also available under the Media section of the Company’s website at: www.millennium.com/InTheNews.aspx.

About Millennium

Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a first-in-class proteasome inhibitor, and has a robust clinical development pipeline of product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Ltd. in May, 2008. The Company’s research, development and commercialization activities are focused in oncology. Additional information about Millennium is available through its website, 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 strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

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CONTACT:

Millennium
Manisha Pai, +1-617-551-7877
[email protected]
or
David Albaugh, +1-617-444-4457
[email protected]
or
Takeda Pharmaceutical Company Limited
Corporate Communications Dept. (PR/IR)
+81-3-3278-2037

KEYWORDS:   United States  North America  Massachusetts

INDUSTRY KEYWORDS:   Health  Biotechnology  Clinical Trials  Infectious Diseases  Pharmaceutical  Research  Science

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