The 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Excellence (NICE) has recommended Baxalta’s Oncaspar (pegaspargase), a treatment for a rare form of leukaemia, in final draft guidance.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.