The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product Glivec ( Imatinib ).
The CHMP has adopted a new indication as follows: Glivec is indicated for the treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia ( Ph+ ALL ) integrated with chemotherapy.
For information, the full indications for Glivec will be as follows:
Glivec is indicated for the treatment of: adult and paediatric patients with newly diagnosed Philadelphia chromosome ( bcr-abl ) positive ( Ph+ ) chronic myeloid leukaemia ( CML ) for whom bone marrow transplantation is not considered as the first line of treatment; adult and paediatric patients with Ph+ CML in chronic phase after failure of Interferon-alpha therapy, or in accelerated phase or blast crisis; adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia ( Ph+ ALL ) integrated with chemotherapy; adult patients with relapsed or refractory Ph+ ALL as monotherapy; adult patients with myelodysplastic/myeloproliferative diseases ( MDS/MPD ) associated with platelet-derived growth factor receptor ( PDGFR ) gene re-arrangements; adult patients with advanced hypereosinophilic syndrome ( HES ) and/or chronic eosinophilic leukaemia ( CEL ) with FIP1L1-PDGFRalpha rearrangement.
The effect of Glivec on the outcome of bone marrow transplantation has not been determined.
Glivec is indicated for: the treatment of adult patients with Kit ( CD 117 ) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours ( GIST ); the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit ( CD117 )-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment; the treatment of adult patients with unresectable dermatofibrosarcoma protuberans ( DFSP ) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.
In adult and paediatric patients, the effectiveness of Glivec is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic GIST and DFSP and on recurrence-free survival in adjuvant GIST.
The experience with Glivec in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited. Except in newly diagnosed chronic phase chronic myeloid leukaemia, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases. ( Xagena )
Source: EMA, 2013