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FDA Approves Darzalex Faspro as Subcutaneous Formulation for All Patients with Multiple Myeloma

Web Exclusives - FDA Updates

On May 1, 2020, the FDA approved a new formulation of daratumumab (Darzalex; Janssen Biotech) and hyaluronidase-fihj (Faspro; Janssen Biotech) for the treatment of adults with newly diagnosed or with relapsed or refractory multiple myeloma. This new formulation of daratumumab plus hyaluronidase-fihj allows for the subcutaneous administration of daratumumab in addition to the intravenous (IV) administration, offering all patients with multiple myeloma a new and more convenient dosing option. In this new approach, daratumumab is co-formulated with the recombinant human hyaluronidase PH20 enzyme, using the ENHANZE drug delivery technology.

“The Multiple Myeloma Research Foundation shares a common goal with Janssen in advancing treatments for multiple myeloma and addressing the unmet needs of this patient community,” said Paul Giusti, President and CEO of the Multiple Myeloma Research Foundation. “The approval of Darzalex Faspro marks an important milestone which will help make a positive difference in the lives of patients who depend on this effective therapy.”

Daratumumab and hyaluronidase-fihj is approved for the treatment of patients with multiple myeloma for the following indications that were previously approved by the FDA for IV daratumumab, including (1) in combination with bortezomib (Velcade), melphalan, and prednisone (D-VMP) in newly diagnosed patients who are ineligible for autologous stem-cell transplant; (2) in combination with lenalidomide (Revlimid) and dexamethasone (D-Rd), for first-line treatment of patients who are ineligible for transplant or for patients with relapsed or refractory disease after at least 1 previous therapy; (3) in combination with bortezomib and dexamethasone after at least 1 previous therapy for multiple myeloma; and (4) as monotherapy, after at least 3 previous lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or in patients who are double refractory to a PI and an IMiD.

The FDA approved the new formulation of daratumumab and hyaluronidase-fihj (monotherapy) based on the COLUMBA study, an open-label noninferiority clinical trial that randomized 263 patients to daratumumab and hyaluronidase-fihj and 259 patients to IV daratumumab. The co-primary end points were overall response rate (ORR) and the pharmacokinetic end point of the maximum Ctrough on cycle 3 day 1 predose. Daratumumab and hyaluronidase-fihj was noninferior to daratumumab IV for the 2 end points. The ORR was 41.1% for daratumumab and hyaluronidase-fihj versus 37.1% for daratumumab IV (hazard risk, 1.11; 95% confidence interval [CI], 0.89-1.37).

The efficacy of daratumumab and hyaluronidase-fihj in combination with D-VMP was evaluated in a single-arm cohort of PLEIADES, a multicohort, open-label clinical trial. Eligible patients had newly diagnosed multiple myeloma and were ineligible for transplant. The ORR was 88.1% with the new formulation of daratumumab (95% CI, 77.8-94.7). The efficacy of daratumumab and hyaluronidase-fihj in combination with D-Rd was evaluated in a single-arm cohort of PLEIADES. Eligible patients had received at least 1 previous therapy and had an ORR of 90.8% (95% CI, 81.0-96.5).

The most common (≥20%) adverse event with daratumumab and hyaluronidase-fihj monotherapy is upper respiratory tract infection. The most common events with D-VMP are upper respiratory tract infection, constipation, nausea, fatigue, pyrexia, peripheral sensory neuropathy, diarrhea, cough, insomnia, vomiting, and back pain. The most common adverse reactions with D-Rd are fatigue, diarrhea, upper respiratory tract infection, muscle spasms, constipation, pyrexia, pneumonia, and dyspnea.

The most common (≥40%) hematology laboratory abnormalities with daratumumab and hyaluronidase-fihj are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin.

The recommended dose of daratumumab and hyaluronidase-fihj is 1800 mg of daratumumab and 30,000 units of hyaluronidase, administered subcutaneously into the abdomen over 3 to 5 minutes.

“Since the approval of daratumumab, a robust body of evidence has established its use as a treatment for multiple myeloma in both the frontline and relapsed and refractory settings,” said Saad Z. Usmani, MD, Division Chief of Plasma Cell Disorders, Levine Cancer Institute. “With Darzalex Faspro there may be fewer administration-related reactions compared to intravenous Darzalex, providing an additional treatment option that may help patients, oncologists and nursing staff.”

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Last modified: May 8, 2020