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FDA has approved Kyprolis combination regimen with Darzalex Faspro and Dexamethasone for patients with multiple myeloma at first or subsequent relapse


The U.S. Food and Drug Administration ( FDA ) has approved the expansion of the Kyprolis ( Carfilzomib ) 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 expansion of the Kyprolis prescribing information to include Daratumumab Faspro plus Dexamethasone was 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.

Updated data from the PLEIADES study were presented at the 2020 American Society of Hematology ( ASH ) Annual Meeting, demonstrating that response rates with Carfilzomib in combination with Darzalex Faspro and Dexamethasone were similar to those in the phase 3 CANDOR study ( Carfilzomib combined with intravenous [ IV ] Darzalex and Dexamethasone [ DKd ] ), which supported the first-ever approval of an anti-CD38 monoclonal antibody in combination with Carfilzomib.
The PLEIADES study met its primary endpoint, demonstrating an overall response rate of 84.8 percent with Darzalex Faspro-Kd.

Serious adverse reactions occurred in 27% of patients who received Carfilzomib in combination with Darzalex Faspro and Dexamethasone.
The most common adverse reactions ( 20% or more ) 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.

The ongoing, phase 2, non-randomized, open-label, multicenter PLEIADES trial evaluated the clinical benefit of Darzalex Faspro administered in combination with four standard-of-care treatment regimens in patients with multiple myeloma.
The efficacy of Carfilzomib in combination with Darzalex Faspro and Dexamethasone was evaluated in 66 patients with relapsed or refractory multiple myeloma in a single-arm cohort of PLEIADES.
Carfilzomib was evaluated at a starting dose of 20 mg/m2 on Cycle 1 Day 1, which was increased to 70 mg/m2 as a 30-minute IV infusion on Cycle 1 Day 8 and Day 15, and then Day 1, 8 and 15 of each cycle; Darzalex Faspro 1,800 mg administered subcutaneously once weekly from Weeks 1 to 8, once every 2 weeks from Weeks 9 to 24 and once every 4 weeks starting with Week 25 until disease progression or unacceptable toxicity; and Dexamethasone 40 mg per week.

Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse. It is a rare and life-threatening disease that accounts for approximately 1% of all cancers.
Worldwide, approximately 176,000 people are diagnosed with multiple myeloma each year, and 117,000 patient deaths are reported on an annual basis. ( Xagena )

Source: Amgen, 2021

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