The Food and Drug Administration (FDA) has approved daratumumab and hyaluronidase-fihj in combination with carfilzomib, a proteasome inhibitor, and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.
The approval was based on data from a single-arm cohort of the ongoing, multicenter, multicohort, open-label phase 2 PLEIADES trial (ClinicalTrials.gov Identifier: NCT03412565) evaluating the clinical benefit of daratumumab and hyaluronidase-fihj in combination with 4 standard of care treatment regimens in adults with multiple myeloma. This cohort included 66 patients with relapsed or refractory multiple myeloma who received at least 1 prior line of therapy.
Patients received daratumumab and hyaluronidase-fihj administered subcutaneously with carfilzomib and dexamethasone. The primary endpoint was overall response rate.
Results showed an overall response rate of 84.8% (95% CI, 73.9-92.5). At a median follow-up of 9.2 months, the median duration of response had not been reached; an estimated 85.2% (95% CI, 72.5-92.3) maintained response for at least 6 months and 82.5% (95% CI, 68.9-90.6) maintained response for at least 9 months.
Daratumumab and hyaluronidase-fihj is marketed under the brand name Darzalex Faspro. The subcutaneous formulation is administered over approximately 3 to 5 minutes.
- FDA approves Darzalex Faspro, Kyprolis, and dexamethasone for multiple myeloma. News release. US Food and Drug Administration. Accessed December 1, 2021. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darzalex-faspro-kyprolis-and-dexamethasone-multiple-myeloma?utm_medium=email&utm_source=govdelivery.
- 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. News release. Amgen. Accessed December 1, 2021. https://www.prnewswire.com/news-releases/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-301435467.html.
- US FDA approves Darzalex Faspro® (daratumumab and hyaluronidase-fihj) in combination with carfilzomib and dexamethasone for patients with multiple myeloma after first or subsequent relapse. News release. Janssen Pharmaceutical Companies. Accessed December 1, 2021. https://www.prnewswire.com/news-releases/us-fda-approves-darzalex-faspro-daratumumab-and-hyaluronidase-fihj-in-combination-with-carfilzomib-and-dexamethasone-for-patients-with-multiple-myeloma-after-first-or-subsequent-relapse-301435448.html.