FDA’s Approval of Subcutaneous Darzalex-Based Regimen Adds Another ‘Tool in the Toolbox’ to Treat Pretreated Myeloma


A certified oncology nurse and board-certified adult nurse practitioner explained how the recent FDA approval of Darzalex Faspro, Kyprolis and dexamethasone may allow patients with relapsed/refractory multiple myeloma to switch treatments after discovering their current treatment is no longer working.

While Darzalex (daratumumab) plus Kyprolis (carfilzomib) and dexamethasone is a commonly used myeloma regimen that was approved in August 2020, the Food and Drug Administration (FDA) more recently approved Darzalex Faspro (daratumumab plus hyaluronidase-fihj) in combination with Kyprolis and dexamethasone — a steroid — for the treatment of adults with relapsed/refractory myeloma who previously underwent one to three lines of treatment.

The more recent approval is a “technicality,” said Donna Catamero, associate director of myeloma translational research at Mount Sinai Health System in New York, in an interview with CURE®, explaining that Darzalex Faspro is the subcutaneous formulation of the drug, which is given via injection rather than IV infusion, as traditional Darzalex is administered. Many institutions were already using this method for their patients, Catamero believes.

“This combination is exciting as it can be used with a patient’s first relapse,” Catamero said. “Updated data was presented at the ASH 2021 Annual Meeting and Exposition … which showed with longer follow-up, patients had improved progression-free survival.”

Findings from the PLEIADES clinical trial led to the approval of the Darzalex Faspro regimen. They showed that in patients with pretreated relapsed/refractory myeloma, 84.8% responded to treatment with the majority — 85.2% and 82.5% — responding at the six- and nine-month marks, respectively.

Catamero, who is a board-certified adult nurse practitioner and certified oncology nurse, also explained that this could be a good option for patients to switch to a different type of therapy after discovering one type of treatment is not working.

“Patients can discuss this option with their physicians, as this combination offers a class switch if patients are progressing on Revlimid (lenalidomide) maintenance,” she said.

However, like with all cancer treatments, there are side effects that patients need to be aware of — namely severe or fatal heart complications such as heart failure or hypertension that have previously been linked to Kyprolis.

“The side effect is rare, however, patients with pre-existing conditions may be at higher risk,” Catamero said. “Patients who do receive this combination should discuss how their cardiac function will be monitored during treatment.”

Other common side effects that were seen on the PLEIADES trial were: upper respiratory tract infection, fatigue, insomnia, high blood pressure, diarrhea, cough, difficulty breathing, headache, fever, nausea and peripheral edema (swelling of the lower legs and hands).

“Overall, this is an exciting new option,” Catamero said. “This gives us more tools in our toolbox.”

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