This Velcade approval was quite a surprise to me this soon after submission. This ultra-speedy action by the FDA can only help the general tenor of the biotechs, which have already been very strong relative to the overall market.
Press Release
Source: Millennium Pharmaceuticals, Inc.
FDA Approves VELCADE(TM) (bortezomib) for Injection for the Treatment of Relapsed and Refractory Multiple Myeloma
Tuesday May 13, 6:35 pm ET
-- Completely new approach to treating cancer is the first FDA approved proteasome inhibitor --
CAMBRIDGE, Mass., May 13 /PRNewswire-FirstCall/-- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today received approval from the U.S. Food and Drug Administration (FDA) to market VELCADE for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. The effectiveness of VELCADE is based on response rates. There are no controlled trials demonstrating a clinical benefit such as an improvement in survival. VELCADE, the first of a new class of medicines called proteasome inhibitors, is the first treatment in more than a decade to be approved for patients with multiple myeloma - a cancer of the blood.
(Photo: newscom.com )
"The FDA approval of VELCADE represents a major advance in our fight against multiple myeloma," said Kenneth Anderson, M.D., from Dana-Farber Cancer Institute in Boston, Mass. "With its new and unique mechanism of action of inhibiting the proteasome, VELCADE is different from traditional chemotherapies and represents a new treatment option for patients."
"Millennium was established with the goal of using innovative science to develop novel products that would address the unmet medical needs of patients," said Mark Levin, chief executive officer and chairperson of Millennium. "Our success in bringing VELCADE to patients so rapidly reflects the high level of collaboration among many partners, both internally and externally. Moving forward, Millennium will continue its mission of developing breakthrough products that make a difference in patients' lives."
VELCADE and proteasome inhibition represent a completely new approach to treating multiple myeloma. The development of this product is based on the Company's deep understanding of cancer disease pathways and the effect of proteasome inhibition on those pathways. The proteasome is an enzyme complex that exists in all cells and plays an important role in degrading proteins that control the cell cycle and cellular processes. By blocking the proteasome, VELCADE disrupts numerous biologic pathways, including those related to the growth and survival of cancer cells.
Priority Review
VELCADE(TM) (bortezomib) for Injection was granted Priority Review by the FDA on March 10, 2003 and was approved approximately two months later. In addition, it has been just four and a half years from the first human dose to FDA approval, an indication of the importance of VELCADE and proteasome inhibition. As a result of the accelerated approval process and the close collaboration between Millennium, the FDA, the National Cancer Institute and other academic and medical institutions, the development and approval of VELCADE is among the most rapid for a cancer treatment. As part of this accelerated approval, Millennium will be completing preclinical and phase IV clinical studies, including a study of previously untreated multiple myeloma patients.
"Today, the thousands of people living with multiple myeloma in the United States have been given a new treatment option," said Kathy Giusti, president, Multiple Myeloma Research Foundation (MMRF), and a myeloma patient. "The MMRF has been committed to helping accelerate the search for a cure for multiple myeloma and we are proud to have been able to work with Millennium in bringing this important new therapy to patients."
"VELCADE is the kind of cutting-edge treatment for which we have been advocating, and provides a new treatment option for the thousands of patients with this disease," said Susie Novis, president, International Myeloma Foundation (IMF). "The approval of VELCADE represents a major milestone in our quest to see new treatments made available to patients with multiple myeloma."
Clinical Results
The FDA approval of VELCADE is based primarily upon the results of a major multicenter phase II open-label, single-arm (SUMMIT) trial, which included 202 patients with relapsed and refractory multiple myeloma receiving at least two prior therapies (median of six). Patients had advanced disease, with 91 percent refractory to their most recent therapy prior to study entry. Response rates were independent of the number or type of previous therapies.
Key findings for the 188 patients evaluable for response showed:
-- Overall, the response rate for complete and partial responders was 27.7
percent (criteria per Blade, et al(1)) (95 percent CI; 21, 35);
-- Significantly, 17.6 percent - or almost one out of every five patients
- experienced a clinical remission(2) (SWOG criteria) (95 percent CI;
12, 24);
-- The median survival for all patients was 16 months (range was less than
one to greater than 18 months);
-- The median duration of response for complete and partial responders was
12 months (95 percent CI; 224 days; NE); and
-- Side effects were generally predictable and manageable.
Important Safety Information About VELCADE
VELCADE(TM) (bortezomib) for Injection is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol.
In 228 patients who were treated with VELCADE in two phase II studies of multiple myeloma, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise and weakness) (65 percent), nausea (64 percent), diarrhea (51 percent), appetite decreased (including anorexia) (43 percent), constipation (43 percent), thrombocytopenia (43 percent), peripheral neuropathy (including peripheral sensory neuropathy and peripheral neuropathy aggravated) (37 percent), pyrexia (36 percent), vomiting (36 percent), and anemia (32 percent). Fourteen percent of patients experienced at least one episode of grade four toxicity, with the most common toxicity being thrombocytopenia (three percent) and neutropenia (three percent).
Please see accompanying full Prescribing Information at millennium.com; |
