Glivec

Oncology· 77 cited findings· 1 source document

What the regulatory reviews say

Glivec is indicated for the treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in children and adolescents. In this population, a complete remission rate of more than 90% was observed at the end of induction therapy. For very high-risk (VHR) ALL, the expected 5-year event-free survival (EFS) is less than 45%.

In a cohort of patients (cohort 5), the four-year EFS was 69.6% compared to 31.6% in historical controls, with a Hazard Ratio for EFS of 0.28 (95% CI: 0.16-0.49). The estimated overall survival (OS) rate at 48 months in cohort 5 was 83.6%, versus 44.8% in the historical control group. The 5-year overall survival rate for ALL is reported to be greater than 85 percent. Deaths on therapy for patients receiving chemotherapy plus imatinib were 2, which was comparable to 2 deaths in the Ph- control group. The proportion of patients who died due to malignant disease progression was 8.7% in Ph+ ALL patients receiving chemotherapy + imatinib, compared to 27.7% in Ph- patients.

The recommended dose for pediatric Ph+ CML is 340 mg/m2 daily, and for adult Ph+ ALL, it is 600 mg/day. The proposed posology for pediatric Ph+ ALL is 340 mg/m2. Post-marketing exposure data indicates 776,114 patient-years. An observational registry study report is due by 31/12/2020.

Key figures — cited to the source page

Four-year EFS in cohort 5	69.6	Novartis AG — Glivec EMA EPAR variation assessment report (E, p.64
Four-year EFS in historical controls	31.6	Novartis AG — Glivec EMA EPAR variation assessment report (E, p.64
Hazard Ratio for EFS (cohort 5 vs historical controls)	0.28	Novartis AG — Glivec EMA EPAR variation assessment report (E, p.64
Estimated OS rate at 48 months in cohort 5	83.6	Novartis AG — Glivec EMA EPAR variation assessment report (E, p.64
Estimated OS rate at 48 months in historical control group	44.8	Novartis AG — Glivec EMA EPAR variation assessment report (E, p.64
Complete remission rate at end of induction therapy for children and adolescents with ALL	More than 90 %	Novartis AG — Glivec EMA EPAR variation assessment report (E, p.4
Proportion of patients who died due to malignant disease progression (Ph+ ALL patients receiving chemotherapy + imatinib)	8.7%	Novartis AG — Glivec EMA EPAR variation assessment report (E, p.50
Recommended dose for paediatric Ph+ CML	340 mg/m2	Novartis AG — Glivec EMA EPAR variation assessment report (E, p.5

Source documents

Novartis AG — Glivec EMA EPAR variation assessment report (EMEA/H/C/000406, 2001) (2001)

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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.