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Amgen leukaemia drug gets FDA priority review

Adds to breakthrough status for blinatumomab
FDA headquarters

Amgen has been awarded a shorter review time for its acute lymphoblastic leukaemia (ALL) therapy blinatumomab that could see it reach the US market in the first half of 2015.

Blinatumomab is the lead candidate in the firm's bispecific T cell engager (BiTE) antibody programme, which creates drug candidates that work by directing the body's cell-destroying T lymphocytes to attack malignant cells.

Amgen acquired rights to blinatumomab and other BiTE antibodies when it bought German biotech Micromet for $1.16bn in 2012.

The FDA has granted priority review status for blinatumomab for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor ALL, a particularly virulent and hard-to-treat form of leukaemia, on the strength of positive phase II trial data which showed it achieved a 72 per cent complete response rate.

The lead investigator in the phase II study - Professor Max Topp of the University of Wuerzburg in Germany - said that the remission rate observed was a "vast improvement over the current standard of care".

Blinatumomab - which targets CD19- and CD3-expressing cells - is also in phase II trials for non-Hodgkin's lymphoma (NHL) and, according to analysts at JP Morgan, could become a $500m-plus product at peak.

It has also been awarded breakthrough status by the FDA, a mechanism designed to speed up the review process for new drugs in serious or life threatening conditions that have shown substantial improvements over existing options during clinical trials. Breakthrough status also makes drugs eligible for priority review, which reduces the review time by up to six months.

The FDA is now due to deliver a verdict on the application by May 19, and Amgen has also filed for approval of the drug for this indication in Europe.

Amgen's head of R&D Sean Harper said the FDA priority review "underscores the need to provide new treatment approaches for adult patients with relapsed or refractory ALL," adding that blinatumomab "has the potential to make a significant impact for these patients."

Amgen's BiTE pipeline also includes anti-EpCAM (epithelial cell adhesion molecule) and anti-CD3 candidate AMG 110, which is in phase I testing in several solid tumour types.

Article by
Phil Taylor

10th October 2014

From: Sales, Regulatory



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