Johnson & Johnson has announced that its Darzalex Faspro-based regimen (daratumumab and hyaluronidase, in combination with bortezomib, lenalidomide and dexamethasone (D-VRd)), has received approval from the US FDA to treat adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
The approval is based on results from the phase 3 CEPHEUS study, which compared the safety and efficacy of the D-VRd regimen with bortezomib, lenalidomide and dexamethasone (VRd) alone.
Almost five years later, the Darzalex Faspro-based regimen showed significantly increased rates of complete response or better at 81.2% vs 61.6% with VRd. The study showed that the safety profile of the Darzalex Faspro-based regimen was favourable, with the most common adverse events including upper respiratory tract infection, sensory neuropathy and musculoskeletal pain.
Multiple myeloma is a blood cancer affecting plasma cells. It is the second most common blood cancer globally. Estimates suggest that over 36,000 people will be diagnosed with multiple myeloma in the US, with over 12,000 deaths in 2026. Multiple myeloma has an average five-year survival rate of 59.8% and is currently incurable.
Darzalex Faspro received approval from the FDA in May 2020, and is already approved for eleven indications in multiple myeloma.
June Lanoue, US president, haematology at Johnson & Johnson, said: “This approval marks the twelfth indication for Darzalex Faspro overall and fifth in newly diagnosed multiple myeloma, underscoring its role as foundational therapy for both newly diagnosed and relapsed/refractory patients.
“CEPHEUS demonstrated the efficacy of [D-VRd] as a frontline standard of care. With this approval, patients can receive D-VRd when they are first diagnosed with multiple myeloma, an important milestone as we work to one day deliver a functional cure.”