Millennium Pharmaceuticals, Inc. announced the US FDA accepted for review the Company's supplemental New Drug Application (sNDA) and granted Priority Review designation for Velcade for the treatment of patients with multiple myeloma who have received at least one prior therapy.

The submission was based on data from the phase III APEX study that compared Velcade to a traditional myeloma therapy, high-dose dexamethasone, which demonstrated a statistically significant survival in patients receiving Velcade, a company release said here.

Priority Review of a sNDA is granted by the FDA for a treatment that addresses an unmet medical need. The FDA expedites the approval process for such an sNDA by reducing the standard review period for the application from ten months to six months. Acceptance of the filing means the FDA has made a threshold determination that the sNDA is sufficiently complete to permit a substantive review.

"We are excited that more patients may soon have access to Velcade earlier in their treatment where Velcade has shown a significant improvement over a standard therapy in delaying disease progression and improved survival," said David Schenkein, vice president, clinical oncology development, Millennium. "Millennium is committed to making a difference in patients' lives, and will continue in partnership with Johnson & Johnson Pharmaceutical Research and Development L.L.C., to extensively research the benefits of Velcade extensively across the multiple myeloma treatment paradigms as well as in other hematologic and solid tumours," he added.

The acceptance of this supplementary filing comes approximately eighteen months after the FDA approval of 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. 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.

The sNDA submission was based primarily upon the results of the phase III APEX confirmatory study that compared Velcade to high-dose dexamethasone. The APEX trial was halted one year early after an independent data monitoring committee concluded the findings of a pre-specified interim analysis showed a statistically significant improvement in time-to-disease progression in favour of Velcade, the release said.

Millennium and Johnson & Johnson Pharmaceutical Research and Development, L. L. C., continue to investigate Velcade globally in both hematologic and solid tumours and currently have approximately 80 ongoing clinical trials.