Posted by Michael Wonder on 24 Jan 2019
Genmab announces initiation of U.S. FDA regulatory submission for label expansion of daratumumab in combination with lenalidomide and dexamethasone in front line multiple myeloma
22 January 2019 - First part of regulatory package submitted to the U.S. FDA for label expansion of daratumumab in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are not candidates for high dose chemotherapy and autologous stem cell transplant.
Genmab announced today that its licensing partner Janssen has submitted the first part of a regulatory submission to the U.S. FDA for a label expansion to include the use of daratumumab in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are not candidates for high dose chemotherapy and autologous stem cell transplant.
The U.S. FDA plans to review this application under their Real-Time Oncology Review pilot program. Inclusion in the pilot program does not guarantee or increase the probability of approval of this supplemental biologics license application.
