Accelerated EU Committee Nod for J&J/Genmab's Darzalex
This article was originally published in Scrip
Janssen-Cilag (Johnson & Johnson) and Genmab's CD38 monoclonal antibody product Darzalex (daratumumab) has been granted the green light for approval in adults with relapsed and refractory multiple myeloma, under an accelerated procedure.
You may also be interested in...
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.
The latest approval for Johnson & Johnson's monoclonal antibody therapy Darzalex in multiple myeloma keeps the product firmly on course as a much-needed new option in relapsed/refractory patients but competition in the market is hotting up all the time.
This quarter has already seen a complete response letter for Iterum Therapeutics’ antibiotic sulopenem but a raft of other products are expecting approval decisions from the US Food and Drug Administration in the next three months. With the help of analysts at Biomedtracker, Scrip takes a look at 10 of the more interesting ones.