Expanded US Approval Set To Take Janssen’s Darzalex Higher
Janssen’s multiple myeloma therapy, Darzalex, has won an additional US approval for use earlier in the treatment paradigm, building momentum for a product that has already got off to a strong start.
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The company's proteasome inhibitor reduced the risk of death in combination with J&J's CD38 inhibitor in a Phase III trial. A day earlier, Amgen reported clinical holds on its Phase I MCL-1 inhibitors due to cardiac safety.
Keeping Track: Approvals For Xultophy, Soliqua And Darzalex; NDAs From Intarcia And GSK; Complete Response For Green Cross
The latest drug development news and highlights from our FDA Performance Tracker
Pharma says pipeline is poised to continue growth with 10 NMEs to be approved between 2015-2019 that could produce blockbuster sales. J&J adds that it’s planning 40 line extensions, with 10 that could yield $500m annually each.