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Johnson and Johnson partner Genmab inc. said Friday that its myeloma drug Darzalex has been approved in combination with the chemotherapy drugs Desamisson and Celgene Pomalyst to treat patients with multiple myeloma who have previously received at least two rounds of treatment. Previous treatments include Celgene's REVLIMID and protease inhibitors such as Takeda's Wanyu.
approval of the treatment was based primarily on Phase I study data. Phase 1 trials showed that the Darzalex program may trigger an effective response in 59% of patients, with an average duration of 13.6 months.
this is just one of the combination therapies approved by Darzalex for J.J. and Genmab. As early as last November, Darzalex was approved for use in patients who had previously received a round of treatment, in association with dexamisson and Relimid or Wanyu.
The approval has helped Darzalex significantly expand its target population, not only attracting patients who want to continue chemotherapy, but also helping Darzalex gain an edge in the competition with new drugs from Takeda Ninlaro, AbbVie and Spelt's Empliciti and other new myeloma competitors, all of which have been approved by the FDA for second-line cocktail therapies.
the expansion of the myeloma market, johnson and Genmab drugs in the lymphoma market is not optimistic. In April, data showed that three types of recurring or resusable non-Hodgkin's lymphoma, which was used alone, did not meet the criteria for overall response rates. In response, Genmab said it would not conduct phase 2 clinical trials.