FDA Approves Daratumumab With Hyaluronidase-Fihj, Plus Carfilzomib/Dexamethasone to Treat Select Multiple Myeloma


The FDA has granted an approval to a subcutaneous daratumumab combination to treat adults with relapsed/refractory multiple myeloma.

The FDA has approved daratumumab (Darzalex) and hyaluronidase-fihj (Darzalex Faspro) and carfilzomib (Kyprolis) plus dexamethasone as a therapy option for adults with relapsed or refractory multiple myeloma and have received between 1 and 3 prior lines of therapy.

The regulatory decision is supported by findings from the ongoing PLEIADES trial (NCT03412565), which assessed 66 pretreated patients with relapsed or refractory multiple myeloma. Patients received daratumumab and hyaluronidase at 1800-mg/30,000 units subcutaneously while also receiving carfilzomib at 20/70 mg/m2 once weekly and dexamethasone.

The overall response rate (ORR) among patients who received the regimen was 84.8% (95% CI, 73.9%-92.5%). The median duration of response had not been reached at a median follow-up of 9.2 months. Approximately 85.2% (95% CI, 72.5-92.3) maintained their responses for 6 months and 82.5% (95% CI, 68.9-90.6) reported a maintained response after 9 months.

Serious adverse events (AEs) associated with treatment occurred in 27% of participants. The most prevalent AEs included upper respiratory tract infection, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, pyrexia, nausea, and peripheral edema. Three percent of patients experienced a fatal AE.

The recommended dosing for daratumumab with hyaluronidase is 1800 mg/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously. Administration should be once weekly for weeks 1 through 8, biweekly from weeks 9 through 24, and every 4 weeks from week 25 until either disease progression or unacceptable toxicity.

When carfilzomib is administered in conjunction with daratumumab with hyaluronidase, the recommended dosing is once weekly at 20/70 mg/m2 via intravenous (IV infusions). These infusions should be administered for 30 minutes on cycle 1, day 1 at a 20/mg/m2 dosage. If this is tolerated, 70 mg/m2 as a 30-minute IV infusion on cycle 1, day 8 and day 15, is recommended and should continue for each 28-day cycle.

Alternatively, carfilzomib may also be administered twice weekly via IV infusion at a 20/56 mg/m2 dosage. If on cycle 1, day 1, at a dose of 20 mg/m2 is tolerated, then the dose should be increased to 56 mg/m2 for days 2, 8, 9, 15, and 16 of the 28-day cycle.

"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 DKd treatment regimen will be a welcomed option for many of our patients," said Saad Z. Usmani, MD, chief of Myeloma Service at Memorial Sloan Kettering Cancer Center. "Administration time can be drastically reduced, as compared to the intravenous daratumumab formulation in combination with carfilzomib and dexamethasone."


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. Cision. News release. December 1, 2021. Accessed December 1, 2021. https://prn.to/3xFK3EI

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