Late last year, Johnson & Johnson widened Darzalex’s reach with some combo approvals. And now, it’s adding to that roster.
The medication has snagged a green light for use in tandem with chemo drug dexamethasone and Celgene’s Pomalyst for multiple myeloma patients who have already tried at least two prior therapies, including fellow Celgene med Revlimid and a proteasome inhibitor such as Takeda’s Velcade, J&J partner Genmab said Friday.
The approval comes based on a phase 1 study that showed the Darzalex regimen could trigger a response in 59% of patients, with those responses lasting a median 13.6 months.
For J&J and Genmab, it’s just the latest Darzalex combo to win a go-ahead from U.S. regulators. Back in November, the team snagged a thumbs up for Darzalex—alongside dexamethasone and either Revlimid or Velcade—as a treatment for patients who had received just one prior therapy.
That regulatory win both opened up Darzalex’ target population—bringing in patients who tend to stay on therapy for longer—and helped even the score between Darzalex and fellow myeloma newcomers Ninlaro from Takeda and Empliciti from AbbVie and Bristol-Myers Squibb, both of which already had FDA clearance in second-line cocktails.
The myeloma expansion comes as J&J and Genmab drug have faced some struggles in the lymphoma realm. In April, Genmab said it wouldn’t move the medication into the second stage of a phase 2 trial looking at the med as a monotherapy in three types of relapsed or refractory non-Hodgkin’s lymphoma after data showed the drug hadn’t hit its overall response rate benchmarks.