FDA Approves J&J's Darzalex Faspro Regimen for Multiple Myeloma

Johnson & Johnson’s (J&J) Darzalex Faspro (daratumumab and hyaluronidase-fihj) has received approval from the US Food and Drug Administration (FDA) for treating newly diagnosed multiple myeloma (NDMM). This subcutaneous medication has been sanctioned for use alongside bortezomib, lenalidomide, and dexamethasone (VRd) in patients who qualify for an autologous stem cell transplant (ASCT).

The FDA's endorsement is based on favorable outcomes from the advanced-stage PERSEUS study. The study revealed that the Darzalex Faspro/VRd regimen decreased the risk of disease progression or death by 60% compared to VRd alone in this patient group. Additionally, the quadruplet therapy administered during both induction and consolidation phases yielded “deeper responses” at the end of consolidation compared to VRd. According to J&J, the safety profile of this regimen aligns with the established safety profiles of Darzalex Faspro and VRd.

Jordan Schecter, vice president and leader in the multiple myeloma disease area at J&J, highlighted that this new indication for Darzalex Faspro-based quadruplet therapy shows a significant clinical reduction in disease progression or death during initial treatment, when patients are likely to encounter their most profound responses.

Multiple myeloma ranks as the second most prevalent blood cancer worldwide, with over 35,000 new cases projected to be diagnosed in the US this year alone. Darzalex Faspro has garnered approval in the US for nine multiple myeloma indications, four of which are for front-line treatment in newly diagnosed patients either eligible or ineligible for transplant.

Amrita Krishnan, professor and director of the Judy and Bernard Briskin Multiple Myeloma Center at City of Hope, explained that multiple myeloma exhibits a highly varied clinical course among patients. Even within individual patients, the disease can present differently, underscoring the continued need for innovative therapies. Such treatments should employ diverse targets and combinations to offer patients various options from diagnosis through the progression of their disease.

This recent FDA approval follows closely on the heels of J&J’s single tablet combination therapy, Yuvanci (macitentan and tadalafil), receiving a recommendation from the European Medicines Agency’s human medicines committee. This therapy is intended for certain adults with pulmonary arterial hypertension. Additionally, the Committee for Medicinal Products for Human Use recommended J&J’s bispecific antibody Rybrevant (amivantamab) in combination with carboplatin and pemetrexed chemotherapy for treating a subset of advanced non-small cell lung cancer patients.

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