FDA cleared a new subcutaneous formulation of daratumumab for multiple myeloma patients.
Daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen) is approved in four regimens across five indications in multiple myeloma patients, including newly diagnosed, transplant-ineligible patients as well as relapsed or refractory patients.
As a fixed-dose formulation, the medication can be administered over approximately three to five minutes, which is significantly less time than Darzalex (Janssen), which is given intravenously over hours, Janssen said in a press release.
Net trade sales of Darzalex reached $463 million in the U.S. and $474 million in the rest of the world in the first quarter of 2020, Genmab said in a press release.
"Since the approval of daratumumab, a robust body of evidence has established its use as a treatment for multiple myeloma in both the frontline and relapsed and refractory settings," said Saad Z. Usmani, MD, division chief of Plasma Cell Disorders at Levine Cancer Institute, in the Janssen press release. "With Darzalex Faspro, there may be fewer administration-related reactions compared to intravenous Darzalex, providing an additional treatment option that may help patients, oncologists and nursing staff.”
In fact, Janssen’s Phase 3 trial showed a nearly two-thirds reduction in systemic administration-related reactions (ARRs) for Darzalex Faspro compared to intravenous Darzalex (13% vs. 34%, respectively).
The study also demonstrated a consistent overall response rate (ORR) and pharmacokinetics and a similar safety profile compared with IV Darzalex, Janssen said.
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