FDA approves Janssen’s AL amyloidosis drug

pharmafile | January 18, 2021 | News story | Sales and Marketing FDA, Janssen 

The FDA has approved Janssen’s DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.

The drug is the first and only FDA-approved treatment for patients with the blood cell disorder, which is associated with the production of an abnormal protein and leads to the deterioration of vital organs. Patients with the condition often have a poor prognosis due to the delay in diagnosis of AL amyloidosis, which frequently presents with non-specific symptoms that can mimic other, more common conditions. As many as 30% of patients with AL amyloidosis die within the first year after diagnosis.

The FDA’s accelerated approval of the treatment is based on positive results from the Phase III ANDROMEDA study, which evaluated DARZALEX FASPRO in combination with VCd, compared with VCd alone, a common treatment regimen used in adult patients with newly diagnosed AL amyloidosis. Patients receiving treatment with DARZALEX FASPRO experienced a haematologic complete response rate (hemCR) more than triple that of patients receiving VCd alone.

DARZALEX FASPRO is not indicated or recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials. 

Dr Raymond L Comenzo, Director of the John C. Davis Myeloma and Amyloid Program at 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 haematologic 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.”  

Darcy Jimenez

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