Please login to the form below

Not currently logged in
Email:
Password:

Rare blood cancer therapy Oncaspar gets NICE green light

Baxalta’s acute lymphoblastic leukaemia treatment recommended for NHS use

BaxaltaThe National Institute for Health and Care Excellence (NICE) has recommended Baxalta's Oncaspar (pegaspargase), a treatment for a rare form of leukaemia, in final draft guidance.

The acute lymphoblastic leukaemia (ALL) drug is indicated for use as a component of antineoplastic combination therapy in newly-diagnosed children, young people and adults who have not yet received treatment for the disease.

Concern was raised over the lack of comparative data submitted to consider Oncaspar against existing treatments - such as German pharma firm Medac's Spectrila (asparaginase) - yet NICE concluded the eight presented studies showed favourable evidence of event-free survival in paediatric and adult ALL patients alike.

The UK watchdog has, however, allowed that further data on the clinical effectiveness of Oncaspar in people of different ages is necessary, seconding the EMA, which called for a post-authorisation study as a condition of the drug's approval.

NICE's provisional recommendation follows six months after Baxalta (now part of Shire) received an EU-wide marketing authorisation for the blood cancer therapy, adding to its existing licences in Germany, Russia and the US.

More common in children than adults, ALL is a rare cancer of lymphocyte blood cells, which are used to fight viral infections. Around 650 patients in the UK are eligible for treatment with Oncaspar, 65% of which are under 25 years of age.

Article by
Rebecca Clifford

1st August 2016

From: Regulatory

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Fendix

Fendix is the only NHS digital media network and it provides organisations, such as pharma, with unrivalled digital access to...

Latest intelligence

2019: CRISPR and therapeutic gene editing comes of age
Can gene-editing deliver safe and effective therapeutics for patients with intractable diseases?...
The 10-year Web Challenge
Understanding your users’ needs is more critical online today than ever. A site should mould itself around these insights, deliver those needs quickly, efficiently and with plenty of white space....
Downloadable Pack: Understanding Multiple Sclerosis
Inside this downloadable pack, you’ll find a wealth of exclusive information on the way multiple sclerosis is commonly treated today. As well as areas of continuous improvement for the industry....

Infographics