Amgen’s Kyprolis recommended by CHMP for expanded EU approval

Amgen has announced that its cancer therapy Kyprolis has been recommended for approval in an expanded indication in the EU.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion to extend the current indication for Kyprolis to include treatment in combination with dexamethasone alone among adult patients with multiple myeloma who have received at least one prior therapy.

Currently, the therapy is approved in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adults.

This recommendation was based on positive data from a phase III head-to-head study of two proteasome inhibitors in relapsed multiple myeloma, which showed that Kyprolis plus dexamethasone nearly doubled progression-free survival compared to the current standard of care.

Dr Sean Harper, executive vice-president of research and development at Amgen, said: "We are pleased that the CHMP has recognised this robust data with a positive opinion, and we look forward to ensuring approval of this extended indication of Kyprolis."

The drug was launched in the UK earlier this year, making it the first licensed irreversible proteasome inhibitor for use as a combination treatment for patients with relapsed multiple myeloma.