U.S. Food and Drug Administration Approves DARZALEX FASPROTM (daratumumab and hyaluronidase-fihj), a New Subcutaneous Formulation of Daratumumab in the Treatment of Patients with Multiple Myeloma

Janssen | Johnson & Johnson

Janssen, a Johnson and Johnson pharmaceutical company, is happy to share some exciting news – The FDA just approved DARZALEX FASPRO, a new subcutaneous formulation approved in four regimens across five indications, including newly diagnosed, transplant-ineligible and relapsed or refractory multiple myeloma.

As you may know, today’s news is based on results from the COLUMBA study. This approval makes DARZALEX FASPRO the only subcutaneous CD38-directed antibody approved in the treatment of multiple myeloma and reduces administration time to approximately three to five minutes.

Johnson and Johnson issued a news release, which is attached here and available here.

Johnson and Johnson is excited to bring this new treatment option to the multiple myeloma community. Many thanks for your continued partnership.

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