Janssen Pharmaceutical of Johnson & Johnson announced the submission of a supplemental Biologics License Application, or sBLA, to the U.S. Food and Drug Administration seeking approval of Darzalex, daratumumab, in combination with bortezomib, thalidomide and dexamethasone for newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant. Yusri Elsayed, Vice President, Hematologic Malignancies Disease Area Leader, Janssen Research & Development, said, “We look forward to working closely with the FDA during review of the submission with the goal of bringing a new treatment option to newly diagnosed patients who are transplant eligible.”
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