EU Clears Amgen’s Kyprolis Cancer Therapy

European regulators have approved the use of Amgen’s cancer drug Kyprolis in combination with just dexamethasone to treat certain adults with multiple myeloma, an incurable blood cancer that is characterized by a recurring pattern of remission and relapse. The drug was initially approved in November 2015 for use in combination with lenalidomide and dexamethasone for treating adult patients who had already received at least one prior therapy.

Amgen said the approval for use with only one other medicine was important because patients often needed to use complex treatment combinations to help keep the disease at bay.

The decision was based on data from a Phase 3 trial which showed that patients with multiple myeloma taking Kyprolis plus dexamethasone achieved superior progression-free survival of more than 18 months compared to just over 9 months for those receiving bortezomib and dexamethasone.

“Kyprolis-based regiments have now shown superiority over two former standard-of-care treatment options for relapsed multiple myeloma patients, reinforcing Kyprolis’ place as a foundational therapy in this patient population,” said Sean Harper, Amgen’s executive vice president of R&D.

Each year in Europe, approximately 39,000 people are diagnosed with multiple myeloma with 24,000 deaths reported.