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Home Industry News Amgen receives EU approval for new multiple myeloma therapy

Amgen receives EU approval for new multiple myeloma therapy

23rd November 2015

Amgen has announced that its new Kyprolis-based combination therapy for multiple myeloma has been approved by the European Commission.

The regulator has ratified Kyprolis 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.

Data from the phase III ASPIRE clinical study has demonstrated the progression-free survival benefits associated with the treatment. Kyprolis received an accelerated assessment from the European Medicines Agency (EMA) and orphan drug designation in 2008.

This is the first irreversible proteasome inhibitor approved in the EU for use in combination treatment of patients with relapsed multiple myeloma.

Dr Sean Harper, executive vice-president of research and development at Amgen, said: "The approval of Kyprolis in combination provides physicians and patients across Europe with an important new treatment option for relapsed multiple myeloma, helping to address a real unmet need for this rare blood cancer."

This comes after the firm's skin cancer therapy Imlygic was recommended for regulatory approval by the EMA's Committee for Medicinal Products for Human Use last month.ADNFCR-8000103-ID-801806338-ADNFCR

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