FDA approves Kyprolis regimen for relapsed or refractory multiple myeloma
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The FDA approved a combination of carfilzomib, a subcutaneous formulation of daratumumab, and dexamethasone for certain patients with relapsed or refractory multiple myeloma.
The expansion of the carfilzomib (Kyprolis, Amgen) prescribing information to include use with daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech) and dexamethasone applies to adults with multiple myeloma who received up to three previous lines of therapy.
“The addition of subcutaneous daratumumab to Kyprolis plus dexamethasone will offer increased flexibility and convenience for patients with relapsed or refractory multiple myeloma and will greatly reduce the administration burden,” David M. Reese, MD, executive vice president of research and development at Amgen, said in a company-issued press release.
Researchers evaluated efficacy of the regimen in a single-arm cohort of the open-label, nonrandomized, phase 2 PLEIADES trial. The cohort included 66 patients with relapsed or refractory multiple myeloma who had at least one previous line of therapy. Patients received 1,800 mg daratumumab and 30,000 units hyaluronidase given subcutaneously in combination with Kyprolis at a starting dose of 20 mg/m2 increased to 70 mg/m2 and dexamethasone.
Overall response rate served as the main efficacy outcome measure.
Results showed an ORR of 84.8% (95% CI, 73.9-92.5) with the combination. Median duration of response had not been reached at median follow-up of 9.2 months. An estimated 85.2% (95% CI, 72.5-92.3) of patients maintained a response for at least 6 months and 82.5% (95% CI, 68.9-90.6) had responses that lasted at least 9 months.
Twenty-seven percent of patients who received the combination experienced serious adverse reactions. The most common adverse reactions included upper respiratory tract infections, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, pyrexia, nausea and peripheral edema. Three percent of patients experienced fatal adverse reactions.
“Managing and coping with relapsed disease is a particularly challenging time in a patient's treatment journey, and having the option of subcutaneous daratumumab as part of the [carfilzomib and dexamethasone] treatment regimen will be a welcomed option for many of our patients," Saad Z. Usmani, MD, MBA, FACP, chief of the myeloma service at Memorial Sloan Kettering Cancer Center, said in the press release. “Administration time can be drastically reduced, as compared to the intravenous daratumumab formulation in combination with carfilzomib and dexamethasone.”
References:
FDA approves new Kyprolis (carfilzomib) combination regimen with Darzalex Faspro (daratumumab and hyaluronidase-fihj) and dexamethasone for patients with multiple myeloma at first or subsequent relapse. https://www.amgen.com/newsroom/press-releases/2021/12/fda-approves-new-kyprolis-carfilzomib-combination-regimen-with-darzalex-faspro-daratumumab-and-hyaluronidasefihj-and-dexamethasone-for-patients-with-multiple-myeloma-at-first-or-subsequent-relapse. Published Dec. 1, 2021. Accessed Dec. 1, 2021.
FDA approves Darzalex Faspro, Kyprolis, and dexamethasone for multiple myeloma. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darzalex-faspro-kyprolis-and-dexamethasone-multiple-myeloma?utm_medium=email&utm_source=govdelivery. Published Dec 1, 2021. Accessed Dec. 1, 2021.
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