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U.S. FDA Grants Priority Review for Daratumumab in Front Line Multiple Myeloma
Jan. 22, 2018 09:16AM PST
Biotech InvestingGenmab (CPH:GEN) announced that the U.S. Food and Drug Administration has granted Priority Review to the supplemental Biologics License Application for the use of daratumumab in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. As quoted in the press …
Genmab (CPH:GEN) announced that the U.S. Food and Drug Administration has granted Priority Review to the supplemental Biologics License Application for the use of daratumumab in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
As quoted in the press release:
“The granting of priority review to the submission of daratumumab in front line multiple myeloma is an important step forward towards potentially bringing this product to an even larger number of patients in need,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.