Amgen : FDA Approves Kyprolis Combination Regimen For Multiple Myeloma Treatment

(RTTNews) - Amgen (AMGN) said that the U.S. Food and Drug Administration has approved the expansion of the Kyprolis or carfilzomib U.S. prescribing information to include its use in combination with Darzalex Faspro (daratumumab and hyaluronidase-fihj) and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.

The approval is supported by the ongoing, phase 2, non-randomized, open-label, multicenter PLEIADES trial evaluating the clinical benefit of Darzalex Faspro administered in combination with four standard-of-care treatment regimens in patients with multiple myeloma. The study met its primary endpoint, demonstrating an overall response rate of 84.8 percent with Darzalex Faspro-Kd.

Amgen noted that serious adverse reactions occurred in 27% of patients who received KYPROLIS in combination with DARZALEX FASPRO and dexamethasone. The most common adverse reactions (=20%) were upper respiratory tract infection, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, pyrexia, nausea and peripheral edema. Fatal adverse reactions occurred in 3% of patients.

Amgen said it will be submitting marketing applications globally.

Darzalex Faspro And Darzalex are registered trademarks of Johnson & Johnson.