DARZALEX FASPRO FDA approval for AL amyloidosis : Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, has secured approval from the US Food and Drug Administration (FDA) for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide, and dexamethasone (D-VCd) for the treatment of light chain (AL) amyloidosis, which has been newly diagnosed in adult patients.
DARZALEX FASPRO is a subcutaneous formulation of daratumumab.
It is now the first and only AL amyloidosis treatment to have been approved by the FDA. Amyloidosis is a blood cell disorder associated with the production of amyloid, an abnormal protein.
Amyloid causes deterioration of vital organs, especially the heart, kidneys, and liver.
DARZALEX FASPRO FDA approval for AL amyloidosis has been granted under accelerated approval and driven by the hematologic complete response rate (hemCR) measure.
Continued approval for the indication could be subject to verification and description of clinical benefit in a confirmatory trial.
DARZALEX FASPRO is not approved and is not recommended for patients having light chain amyloidosis and also NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.
Isabelle Lousada – Founder and CEO of Amyloidosis Research Consortium, commenting on DARZALEX FASPRO FDA approval for AL amyloidosis, said: “Today’s milestone is an important step for patients diagnosed with this rare disease.
“Sadly, most patients with AL amyloidosis are diagnosed more than one year after their initial symptoms present, at a time when they may already be experiencing organ deterioration or failure.
“I believe this approval will increase awareness of and education around this life-threatening disease and offer new hope for people with AL amyloidosis and their caregivers.”
DARZALEX FASPRO FDA approval for AL amyloidosis treatment has been driven by positive results from the phase 3 clinical trial ANDROMEDA.
The late-stage trial assessed DARZALEX FASPRO plus VCd, in comparison to VCd alone, which is a common treatment regimen used in adults having newly diagnosed AL amyloidosis.
Patients subjected to DARZALEX FASPRO had their hemCR more than triple that of patients given VCd alone in the ANDROMEDA clinical trial.
Commenting on DARZALEX FASPRO FDA approval for AL amyloidosis, Raymond L. Comenzo – Director, John C. Davis Myeloma and Amyloid Program, Tufts Medical Center, and ANDROMEDA study investigator, said: “There is an urgent need for awareness and treatment options to help in the fight against this serious blood cell disorder.
“Achieving hematologic complete response is an important treatment goal, and today’s approval based on this clinical endpoint will provide doctors and the larger medical community with a new option to treat newly diagnosed patients.”