FDA Grants Priority Review Status To Supplement Containing Long-Term Survival Data For VELCADE(R) (bortezomib) For Injection

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Blood / Hematology;  Cancer / Oncology;  Regulatory Affairs / Drug Approvals
Article Date: 22 Sep 2009 - 0:00 PDT

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Millennium: The Takeda Oncology Company announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the Company's supplemental new drug application (sNDA) for VELCADE. The sNDA contains long-term overall survival (OS) data from the landmark VISTA1 trial examining the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

The VISTA trial is the largest Phase III registration study to report long-term overall survival in previously untreated multiple myeloma patients. This multicenter, international Phase III clinical trial compared VELCADE in combination with melphalan and prednisone (VcMP) to melphalan and prednisone (MP) alone in patients with previously untreated MM who were not eligible for stem cell transplantation. In VISTA, the VcMP arm demonstrated a statistically significant improvement in all efficacy endpoints, including time-to-tumor progression, complete response, overall response, progression-free survival, and OS compared to the MP arm.

"The data in this filing, derived from long-term follow up of the international VISTA trial, give us additional confidence in the sustained clinical benefit of VELCADE based therapy in previously untreated multiple myeloma patients," said Nancy Simonian, M.D., Chief Medical Officer, Millennium.

Priority review is granted by the FDA for drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists. The FDA expedites the approval process from ten to six months for applications granted priority review.

Updated VISTA long-term OS data are expected to be presented at a forthcoming scientific conference. VISTA was conducted by Janssen-Cilag in collaboration with Millennium.

About Multiple Myeloma

Multiple myeloma is the second most common hematologic malignancy and although the disease is predominantly a cancer of the elderly (the median age of onset is 70 years), recent statistics indicate both increasing incidence and younger age of onset. In the U.S., more than 50,000 individuals have MM and 20,000 new cases are diagnosed each year. Worldwide there are approximately 74,000 new cases and over 45,000 deaths annually.

About VISTA

The international Phase III VISTA trial was conducted by Millennium and its co-development partner JJPRD. The trial randomized 682 patients with newly diagnosed multiple myeloma, ineligible for stem cell transplantation, to receive either VELCADE, melphalan and prednisone (VcMP) or melphalan and prednisone (MP) alone,. The primary endpoint of the trial was time-to-disease progression, with secondary endpoints including overall survival, progression-free survival, response rates, and safety. Results include:

- Time-to-disease progression (TTP) in the VcMP arm was 21 months compared to 15 months in the MP arm (p=0.000002).

- Complete response (CR) rate (using EMBT criteria) of 30 percent in the VcMP arm compared to 4 percent in the MP arm.

- VcMP demonstrated statistical significance in overall survival with a 39 percent reduction in risk of death (p=0.00782). Median survival was not reached at initial analysis due a short follow-up of 16 months. These survival data are updated in the sNDA filing.

About VELCADE

VELCADE is co-developed by Millennium Pharmaceuticals, Inc. and 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. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan. VELCADE is approved in more than 87 countries worldwide.

About Millennium

Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE® (bortezomib) for Injection, 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, http://www.millennium.com.

1 VELCADE as Initial Standard Therapy in multiple myeloma: Assessment with melphalan and prednisone

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Millennium