Supplemental approval in multiple myeloma for Genmab's Darzalex
Danish drugmaker Genmab (Nasdaq: GEN) has won US approval for Darzalex (daratumumab), in combination with lenalidomide and dexamethasone (Rd) to treat people with multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
The label expansion was awarded to the firm’s development partner, Janssen, part of Johnson & Johnson (NYSE: JNJ), which has an exclusive global license for the product, under the terms of a 2012-signed deal.
The drug was granted approval under the US Food and Drug Administration's new Real-Time Oncology Review (RTOR) pilot program, which seeks to create a more efficient review process.
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