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www.fdanews.com/articles/71502-velcade-for-injection-phase-ii-clinical-trial-initiated-in-lung-cancer

Velcade for Injection Phase II Clinical Trial Initiated in Lung Cancer

April 25, 2005

Millennium Pharmaceuticals has announced, in collaboration with Johnson & Johnson (J&J) Pharmaceutical Research & Development, the initiation of PEAK (Prospective Evaluation of bortezomib in Adenocarcinoma with bronchioalveolar features as a Keystone of therapy).

The study is a multicenter Phase II clinical trial of Velcade in patients with either advanced BAC or adenocarcinoma with BAC features that have progressed on or after receiving one to two lines of chemotherapy, one of which must have been an epidermal growth factor receptor tyrosine kinase inhibitor (EGRF TKI).

The open-label study will assess efficacy in terms of tumor response rate measured by Response Evaluation Criteria in Solid Tumors guidelines. Velcade is approved in the U.S. for the treatment of patients who have received at least one prior therapy. Millennium and J&J continue to investigate Velcade globally in Phase I, II and III clinical trials in both hematologic and solid tumors, including frontline multiple myeloma, non-Hodgkin's lymphoma, and lung, prostate and ovarian cancers.