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                                       VELCADE APPROVED FOR MANTLE CELL LYMPHOMA

                                                         Millennium Pharmaceuticals (MLNM)

 

         The FDA has granted full approval of VELCADE for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. MCL is a relatively uncommon and aggressive form of non-Hodgkin's lymphoma for which there was no standard of care in the relapsed or refractory setting.

 

        MCL has a U.S. prevalence of 10,000 patients. VELCADE is currently the market leader in multiple myeloma (MM) for patients who have received one prior therapy.

        The approval marks the first indication for VELCADE in lymphoma, the most common blood cancer. "Mantle cell lymphoma is the most challenging lymphoma to treat because it is commonly resistant to chemotherapy in the relapsed setting," said Andre Goy, M.D., Chief of The Division of Lymphoma, The Cancer Center at Hackensack University Medical Center in Hackensack, N.J. "This approval offers new hope for patients with mantle cell lymphoma who have received at least one prior therapy."

       "VELCADE is the first drug to receive FDA approval in relapsed mantle cell lymphoma and is based upon the data from Phase 2 trial. This represents a new option for patients and a significant milestone for Millennium," said Deborah Dunsire, M.D., President and CEO, Millennium. "In conjunction with our co-development partner, Johnson & Johnson Pharmaceutical Research & Development (J&JPRD), VELCADE is also being investigated in clinical studies in patients with newly diagnosed multiple myeloma and additional types of non-Hodgkin's lymphoma.

 

       "The approval is based on data from the PINNACLE trial, the largest study to date in patients with MCL. PINNACLE was a prospective, multi-center, single-arm, open-label study in patients with MCL whose disease progressed following at least one prior therapy. Response rates to VELCADE were determined according to the International Workshop Response Criteria (IWRC) and based on independent radiologic review of CT scans.

 

       Results of the study, which formed the basis of the approval, include: * Overall response rate of 31 percent * Complete response (CR + CRu) rate of 8 percent * Median duration of response of 9.3 months; 15.4 months in patients achieving a complete response * Median time to progression of 6.2 months.

 

                                                                         Prohost Comments

       The good news means that Velcade, which is a breakthrough drug based on its mode of action is proving it could become a blockbuster. This news validates the drug's efficacy and increases the chances that it would treat many other forms and types of cancer that resist conventional treatments.  As we reiterated in Prohost N-Letters and E-Letters, the market has not considered the value of this breakthrough treatment in the hands of the Millennium's new determined management.  Investors' patience will pay for this firm as observed from the new management's decisions that have been met and iits strategy that makes the future looks promising.

 

 

 

 



 



 
   

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