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Home Industry News Amgen receives EU approval for new Kyprolis indication

Amgen receives EU approval for new Kyprolis indication

5th July 2016

Amgen's cancer drug Kyprolis has been approved as a treatment for relapsed multiple myeloma patients by the European Commission.

The regulator has approved a variation to the marketing authorisation for Kyprolis to include use in combination with dexamethasone alone for adult patients with multiple myeloma who have received at least one prior therapy.

In a head-to-head phase III trial, the combination therapy demonstrated superiority over an established treatment option for patients with relapsed multiple myeloma.

The drug was first approved in Europe in November 2015 for use in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Dr Sean Harper, executive vice-president of research and development at Amgen, said: "Kyprolis-based regimens 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."

The company announced the findings of new analyses of phase III studies last month showing how Kyprolis can help relapsed multiple myeloma patients achieve better progression-free survival rates.ADNFCR-8000103-ID-801821329-ADNFCR

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