EU approves Janssen’s treatments for amyloidosis and multiple myeloma

pharmafile | June 23, 2021 | News story | Research and Development  

The EU has approved Janssen’s DARZALEX SC (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide, and dexamethasone for the treatment of patients with newly diagnosed systemic light-chain amyloidosis, based on data from the ANDROMEDA Phase III study.

Janssen also received EU approval for the same drug in combination with pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma, based on the separate APOLLO Phase III study.

The approvals follow positive opinions by the CHMP of the European Medicines Agency in May 2021.

Jan van de Winkel, Chief Executive Officer of Genmab, said: “AL amyloidosis is a potentially fatal blood disorder for which there is no cure, so we are extremely pleased that patients with AL amyloidosis in Europe may soon have a regimen including DARZALEX SC as a treatment option.

 “We are also pleased that, with the approval based on the APOLLO study, the combination of daratumumab with pomalidomide and dexamethasone will now be a treatment option for certain patients with relapsed or refractory multiple myeloma in Europe.”

The Phase III ANDOMEDA study included 416 patients newly diagnosed with AL amyloidosis.

Patients were randomised to receive treatment with either daratumumab and hyaluronidase-fihj in combination with bortezomib (a proteasome inhibitor), cyclophosphamide (a chemotherapy), and dexamethasone (a corticosteroid) or treatment with VCd alone.

The primary endpoint of the study was the percentage of patients who achieve hematologic complete response.

The Phase III APOLLO study was randomised, open-label, and included 304 patients with multiple myeloma who have previously been treated with lenalidomide and a PI. Patients were randomised 1:1 to either receive daratumumab in combination with Pd or Pd alone. In the original design of the study, patients in the daratumumab plus Pd arm were treated with the intravenous formulation of daratumumab.

The primary endpoint of the study was progression free survival.

Amyloidosis is a disease that occurs when amyloid proteins, which are abnormal proteins, accumulate in tissues and organs.

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterised by an excess proliferation of plasma cells.

Lilly Subbotin

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