Accelerated US approval for Amgen’s breakthrough leukaemia drug

The US Food and Drug Administration (FDA) has approved Amgen’s novel T-cell immunotherapy Blincyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukaemia (B-cell ALL), an uncommon form of ALL.

The drug was granted breakthrough therapy designation, priority review and orphan product designation, based on preliminary clinical evidence that it may offer a substantial improvement over available therapies, and has been approved more than five months ahead of schedule.

Blincyto is the first approved drug that engages the body’s T-cells to destroy leukaemia cells. It connects protein CD19, found on the surface of most B-cell lymphoblasts, and CD3, a protein on T-cell lymphocytes. It is intended for patients whose cancer has returned after treatment (relapsed) or who did not respond to previous treatment (refractory).

Blincyto was evaluated in a phase II study involving 185 adults, 32 per cent of whom were shown to be in complete remission for approximately 6.7 months.

The accelerated programme provides earlier patient access to the drug while the company conducts confirmatory clinical trials. Blincyto carries a boxed warning that some trial participants had problems with low blood pressure and difficulty breathing at the start of the first treatment, experienced a short period of difficulty with thinking or other side effects in the nervous system. The drug has been approved with a Risk Evaluation and Mitigation Strategy (REMS).

Blincyto is also likely to be indicated for other forms of leukaemia. It has orphan drug designation from the FDA for chronic lymphocytic leukaemia (CLL), hairy cell leukaemia, prolymphocytic leukaemia and indolent B-cell lymphoma. In Europe, the European Medicines Agency has granted it orphan status for indolent B-cell lymphoma, ALL, CLL and mantle cell leukaemia (MCL).

Amgen acquired Blincyto when it bought Micromet in 2012. The drug is being co-developed with Astellas for the Japanese market.


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