Brazil's ANVISA nods once-weekly presentation of Amgen’s MM drug Kyprolis

  Brazil's National Health Surveillance Agency (ANVISA) approved a new 70 mg/m2 presentation of Amgen's multiple myeloma (MM) protease inhibitor Kyprolis (carfilzomib). Originally cleared by ANVISA in 2016 with a lower 27 mg/m2 dosage, the new once-weekly presentation will reduce the number of required weekly injections from 2 to 1.

  The approval was based on data from the ARROW clinical study which showed that patients treated with 70 mg/m2 carfilzomib + dexamethasone had a progression-free survival (PFS) of 11.2 months, 3.6 months longer compared to the 27 mg/m2 carfilzomib + dexamethasone therapy.

  MM is an incurable type of blood cancer. Although it is a rare disease that accounts for only 1% of cancer cases, it is the second most commonly diagnosed blood cancer globally, affecting 750,000 patients worldwide, with 114,000 new diagnoses and 80,000 deaths each year. Brazil’s Unified Health System (SUS) reported 2,916 MM patient deaths in 2016.

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