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Amgen's Kyprolis and Blincyto on track for European approval

Double CHMP recommendation backs the myeloma and leukaemia drugs

Two of Amgen's new cancer drugs are set for European approval after receiving the backing of EMA scientific advisers.

The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for the US biotech's myeloma drug Kyprolis and leukaemia drug Blincyto.

Kyprolis (carfilzomib) was recommended for use in combination with Celgene's Revlimid (lenalidomide) and dexamethasone for patients with multiple myeloma who have received at least one prior therapy.

The positive opinion comes from the phase III ASPIRE trial that evaluated Kyprolis in combination with lenalidomide and dexamethasone, versus lenalidomide and dexamethasone alone.

The study showed that patients treated with Kyprolis in combination with lenalidomide had a progression-free survival rate of 26.3 months versus 17.7 months in the lenalidomide and dexamethasone alone group.

The CHMP recommendation follows hard on the heels of last week's good news in the US for Amgen, when Kyprolis was accepted by the FDA for priority review after the submission of a supplementary new drug application.

Meanwhile, Blincyto (blinatumomab) was recommended and is the first bispecific T cell engager (BITE), a new approach that can assist the body's own immune system in fighting cancer. It is used in the treatment for Philadelphia chromosome-negative (Ph-) relapsed or refractory B-precursor acute lymphoblastic leukaemia.

The CHMP nod comes from data from the '211 and '206 studies in which 42.9% of patients receiving Blincyto achieved complete remission or complete remission with partial haematological recovery.

Sean Harper, executive VP of R&D at Amgen, said: “We are pleased to receive positive CHMP opinions for Kyprolis and Blincyto as this an important step in providing new treatment options for patients in Europe with rare forms of cancer.

“For patients with multiple myeloma, periods of remission become shorter following each new treatment regimen, underscoring the need for additional treatment options. There is a critical need for new therapies for patients with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia.”

Article by
Nikhil Patel

29th September 2015

From: Regulatory



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