CAMBRIDGE, Mass., Oct. 15 MillenniumPharmaceuticals, Inc. (Nasdaq: MLNM) today announced that the U.S. Food andDrug Administration (FDA) granted approval for VELCADE use, without doseadjustments, in patients with impaired kidney function, including thoserequiring dialysis. Impaired kidney function is a common complication relatedto multiple myeloma (MM), affecting approximately 30 percent of patients atdiagnosis and a much larger percentage throughout the course of the disease.
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"The ability to use VELCADE without dose adjustments in patients withrenal dysfunction differentiates it from other multiple myeloma therapies,"said Paul Richardson, M.D., Clinical Director, Jerome Lipper Multiple MyelomaCenter at Dana-Farber Cancer Institute Boston and Associate Professor ofMedicine, Harvard Medical School. "Physicians treating multiple myelomapatients want the confidence that therapies are not only efficacious, but alsocan be used consistently and predictably."
"This expansion of the VELCADE label confirms that patients with impairedkidney function can receive the full benefit of VELCADE," said SundarJagannath, M.D., St. Vincent's Comprehensive Cancer Center, New York. "Sincerenal impairment is not an uncommon complication of the disease, VELCADE hasthe potential to benefit the entire population of multiple myeloma patients."
The label expansion is based on data from a prospective Phase Ipharmacokinetic trial in patients with varying degrees of kidney impairments.The results of this study satisfy a post-approval commitment, which wasrequired by the FDA when VELCADE was approved in 2003.
"This label expansion underscores the role of VELCADE as the market-leading therapy in relapsed multiple myeloma, and we believe it will beimportant as we seek to further broaden the VELCADE label, using the data fromour Phase III VISTA trial, to include patients with newly diagnosed multiplemyeloma," said Christophe Bianchi, M.D., Executive Vice President, Commercial,Millennium.
About Multiple Myeloma
Multiple myeloma is the second most common hematologic malignancy andalthough the disease is predominantly a cancer of the elderly (the average ageof onset is 65 to 70 years of age), recent statistics indicate both increasingincidence and younger age of onset. In the U.S., more than 50,000 individualshave MM and 20,000 new cases are diagnosed each year. Worldwide there areapproximately 74,000 new cases and over 45,000 deaths annually.
VELCADE is being co-developed by Millennium Pharmaceuticals, Inc. andJohnson & Johnson Pharmaceutical Research & Development, L.L.C., (JJPRD).Millennium is responsible for commercialization of VELCADE in the U.S.,Janssen-Cilag is responsible for commercialization in Europe and the rest ofthe world. Janssen Pharmaceutical K.K. is responsible for commercialization inJapan. For a limited period of time, Millennium and Ortho Biotech Inc. areco-promoting VELCADE in the U.S. VELCADE is approved in more than 80 countriesworldwide.
In the U.S., VELCADE is indicated for the treatment of patients withmultiple myeloma who have received at least one prior therapy. VELCADE isindicated for the treatment of patients with mantle cell lymphoma who havereceived at least one prior therapy. VELCADE is contraindicated in patientswith hypersensitivity to bortezomib, boron, or mannitol. VELCADE should beadministered under the supervision of a physician experienced in the use ofantineoplastic therapy. In the European Union and many other countriesworldwide, VELCADE is approved for patients with multiple myeloma after firstrelapse.
Risks associated with VELCADE therapy include new or worsening peripheralneuropathy, hypotension observed throughout therapy, cardiac and pulmonarydisorders, gastrointestinal adverse e