Oncaspar

Oncology· 33 cited findings· 1 source document

Company: Servier

What the regulatory reviews say

Oncaspar is a medication indicated for the treatment of Acute Lymphoblastic Leukemia (ALL). Historically, the cure rate for childhood ALL was 5% in 1950, which increased to 85% by 2000. For adult ALL, dose-intense multi-agent regimens have shown remission rates greater than 80%, with a 5-year survival rate of 40%.

The incidence of ALL in children aged 2-3 years is reported to be greater than 90 per million per year, while in children aged 8 years, it is 30 per million. The regulatory process for Oncaspar included a procedure start date of 23 July 2014, leading to a positive opinion for granting Marketing Authorisation on 26 November 2015. Multiple Marketing Authorisation dates are noted, including 6 October 2004, 1 July 2005, 1 August 2005, 15 November 2005, 10 December 2008, and 1 February 1994.

Key figures — cited to the source page

Cure rate for childhood ALL (2000)	85%	Servier — Oncaspar EMA EPAR public assessment report (EMEA/H, p.10
Remission rates for adult ALL with dose-intense multi-agent regimens	>80%	Servier — Oncaspar EMA EPAR public assessment report (EMEA/H, p.10
5-year survival for adult ALL with dose-intense multi-agent regimens	40%	Servier — Oncaspar EMA EPAR public assessment report (EMEA/H, p.10
Positive opinion for granting Marketing Authorisation	26 November 2015	Servier — Oncaspar EMA EPAR public assessment report (EMEA/H, p.9
Incidence of ALL in children aged 2-3 years	>90 per million per year	Servier — Oncaspar EMA EPAR public assessment report (EMEA/H, p.9
Incidence of ALL in children aged 8 years	30 per million	Servier — Oncaspar EMA EPAR public assessment report (EMEA/H, p.9

Source documents

Servier — Oncaspar EMA EPAR public assessment report (EMEA/H/C/003789, 2016) (2016)

Explore the full evidence

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.