Johnson & Johnson’s (J&J) Darzalex Faspro (daratumumab and hyaluronidase-fihj) regimen has been approved by the US Food and Drug Administration (FDA) to treat newly diagnosed multiple myeloma (NDMM).
Subcutaneous Darzalex Faspro has been authorised in combination with bortezomib, lenalidomide and dexamethasone (VRd) for induction and consolidation in NDMM patients who are eligible for an autologous stem cell transplant (ASCT).
The FDA’s decision was supported by positive results from the late-stage PERSEUS study, in which the Darzalex Faspro/VRd regimen reduced the risk of disease progression or death by 60% compared to VRd in this patient population.
The quadruplet therapy during induction and consolidation also results in “deeper responses” at the end of consolidation compared to VRd, J&J said, adding that the regimen’s overall safety profile was consistent with the known safety profiles of Darzalex Faspro and VRd.
Jordan Schecter, vice president, disease area leader, multiple myeloma, J&J, said: “This latest indication for Darzalex Faspro-based quadruplet therapy demonstrated a clinically significant reduction in disease progression or death during first-line treatment when patients are likely to experience their deepest responses.”
Multiple myeloma is the second most common blood cancer globally, with more than 35,000 new cases of the incurable disease expected to be diagnosed this year in the US alone.
Darzalex Faspro is approved in the US for nine multiple myeloma indications, four of which are for front-line treatment in newly diagnosed patients who are transplant-eligible or ineligible.
“Multiple myeloma has a highly varied clinical course among patients and in each individual patient, and there is a continued need for innovation and therapies that employ different targets and combinations to provide patients with treatment options at diagnosis and throughout the course of their disease,” explained Amrita Krishnan, professor and director of the Judy and Bernard Briskin Multiple Myeloma Center, City of Hope.
The latest approval comes just days after J&J’s single tablet combination therapy Yuvanci (macitentan and tadalafil) was recommended by the European Medicines Agency’s human medicines committee to treat certain adults with pulmonary arterial hypertension.
The Committee for Medicinal Products for Human Use also recommended the company’s bispecific antibody Rybrevant (amivantamab) in combination with carboplatin and pemetrexed chemotherapy to treat a subset of advanced non-small cell lung cancer patients.