FDA Approves Darzalex Faspro For Patients with Multiple Myeloma

The Food and Drug Administration (FDA) approved Darzalex Faspro (daratumumab and hyaluronidase-fihj), a subcutaneous form of Darzalex, for adults with newly diagnosed or relapsed/refractory multiple myeloma.

The approval is for indications that the intravenous version of Darzalex had previously received, which include:

• in combination with Velcade (bortezomib), Alkeran (melphalan) and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant,
• in combination with Revlimid (lenalidomide) and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant, and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy,
• in combination with Velcade and dexamethasone in patients who have received at least one prior therapy, and,
• as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent, or who are double refractory to a proteasome inhibitor and an immunomodulatory agent.

The agency based its approval off the results of two trials.

The first, the COLUMBA trial, an open-label non-inferiority trial randomized 263 patients to Darzalex Faspro and 259 to intravenous Darzalex. Overall response rate (ORR) and pharmacokinetics served as the co-primary endpoints for the study.

The ORR was 41.1% for patients who received Darzalex Faspro and 37.1% for those who received intravenous Darzalex.

The second trial, PLEIADES, a multi-cohort, open-label trial, evaluated the efficacy of Darzalex Faspro in combination with Velcade, Alkeran and prednisone. The ORR was 88.1% in that patient cohort.

Additionally, there was a single-arm cohort within this trial that evaluated the efficacy of Darzalex Faspro in combination with Revlimid and dexamethasone. ORR was 90.8% in eligible patients who received at least one prior line of therapy.

A common side effect associated with Darzalex Faspro monotherapy was an upper respiratory tract infection. The most common side effects associated with Velcade, Alkeran and prednisone included an upper respiratory tract infection, constipation, nausea, fatigue, pyrexia, peripheral sensory neuropathy, diarrhea, cough, insomnia, vomiting and back pain. As for Revlimid and dexamethasone, the most common side effects include fatigue, diarrhea, upper respiratory tract infection, muscle spasms, constipation, pyrexia, pneumonia and dyspnea.

The recommended schedule suggests administering 1,800 milligrams (mg) of Darzalex and 30,000 units of hyaluronidase subcutaneously into the abdomen over approximately three to five minutes.