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Daily Brief: Blincyto another option in ALL alongside Kymriah, AZ approval for Bydureon

European approvals for Amgen and AstraZeneca


Blincyto approval puts it in competition with Novartis’ Kymriah

Amgen has gained EU marketing approval to extend use of Blincyto (blinatumomab) in children with acute lymphoblastic leukemia (ALL), putting it into direct competition with Novartis’ new CAR-T treatment Kymriah.

Both treatments are now approved in paediatric and refractory or in relapse after at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation.

One clear difference is that Blincyto is licensed only for patients who are Philadelphia chromosome-negative, which excludes around 3-4% of paediatric patients.

The Blincyto approval is based on results from the Phase 1/2 ‘205 study, an open-label, multicentre, single-arm trial which evaluated Blincyto in paediatric patients with relapsed or refractory B- cell precursor ALL.

In the study of 70 patients, 20 (28.6%) achieved a complete response or complete response with partial haematologic recovery within two treatment cycles; with 17 of 20 responses (85%) occurring within the first cycle.

This doesn’t come close to the remarkable results seen in Kymriah’s pivotal ELIANA study, which found 81% of patients achieved overall remission with 80% of responders still in remission at six months. Sixty percent of patients achieved complete response (CR).

Nevertheless, there is likely to be some room in the market for Blincyto, and could be used ahead of the ‘last resort’ option of Kymriah. Blincyto hasn't proven to be a big earner for Amgen since its launch in 2015 in adults with ALL, but revenues are growing, reaching $175m in 2017.

There are an estimated 5,000 children diagnosed with ALL in Europe each year.

AZ hopes improved Bydureon can retain market share

AstraZeneca has gained approval for a new improved formulation of its once-weekly diabetes treatment Bydureon, aimed at maintaining a share in a competitive market.

The new once-weekly formulation called Bydureon BCise uses a new simpler injection device, and was approved in the US in October.

Sales of Bydureon shrank 2% in the first half of 2018, thanks to a combination of US pricing pressure and growing competition from new rivals in the GLP-1 class.

The drug suffered a major setback last year when it failed to show long-term cardiovascular benefits in type 2 diabetes patients, in contrast to market leading treatments such as Novo Nordisk’s Victoza and Lilly’s Trulicity, and Novo Nordisk's new arrival, Ozempic.

Article by
Andrew McConaghie

30th August 2018

From: Regulatory



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