Wednesday 26 April 2017

Health Canada has approved DARZALEX® (daratumumab) for patients with multiple myeloma who have had at least one prior therapy

TORONTO, April 17, 2017 /CNW/ - Janssen Inc. announced today that Health Canada has approved DARZALEX® (daratumumab), in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. Due to the high unmet medical need for multiple myeloma patients, DARZALEX® was granted a Priority Review by Health Canada for this submission.

Data from two Phase 3 studies supported this new approval. They include the open-label, randomized clinical studies POLLUX (MMY3003) and CASTOR (MMY3004). POLLUX was published in The New England Journal of Medicine, with an accompanying editorial, in October 20167; and CASTOR was published in The New England Journal of Medicine in August 2016.

Studies mentioned:
Dimopoulos, M. A., Oriol, A., Nahi, H., San-Miguel, J., Bahlis, N. J., Usmani, S. Z., . . . Moreau, P. (2016). Daratumumab, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med, 375(14), 1319-1331. doi:10.1056/NEJMoa1607751

Palumbo, A., Chanan-Khan, A., Weisel, K., Nooka, A. K., Masszi, T., Beksac, M., . . . Sonneveld, P. (2016). Daratumumab, bortezomib, and dexamethasone for multiple myeloma. N Engl J Med, 375(8), 754-766. doi:10.1056/NEJMoa1606038

No comments:

Post a Comment