For adults with Ph- CD19+ B-ALL in CR1 or CR2 with MRD ≥ 0,1%
INTERVENE EARLIER
for all that’s ahead
Dear doctor
Medison Pharma is pleased to announce that in April 2020 BLINCYTO has been approved by the Israeli MOH for the treatment of Minimal residual disease (MRD) in adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission. This is in addition to the recent 2020 update in the health basket coverage, approving reimbursement of the Blincyto MRD indication.
Minimal residual disease (MRD) is one of the most important prognostic risk factors in the management of B-ALL. Several studies have shown that achieving MRD negativity, or molecular remission, after frontline treatment is associated with improved overall survival.1-3
BLINCYTO®: 1st and only approved treatment for MRD+ B-ALL patients in CR1 or CR2
This recent approval was based on the results from an open-label, single-arm, phase II study which enrolled 116 patients in hematological complete remission with MRD level above 10-3 or 0,1%:4,5
BLINCYTO®’s safety profile for patients with MRD+ B-ALL was generally manageable.4,5 Patients with MRD+ B-ALL also had the possibility to return home during treatment.4
Consider using BLINCYTO® treatment to help your patients with MRD+ B-ALL achieve molecular remission, and improve their outcome.
Please feel free to contact us if you have any questions about BLINCYTO® or its indications.
Sincierly
Dr. Aviva Grossman
Senior Medical Manager
M: + 972 54 332 1036
Email: avivag@medison.co.il
Noa Giat
Product Manager
M: +972 54 585 6933
Email: NoaG@Medison.co.il
BLINCYTO® is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive relapsed or refractory B‑precursor acute lymphoblastic leukaemia (ALL).
BLINCYTO® is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0,1%.
BLINCYTO® is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B‑precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation.
Limitations of use: After failure of two previous treatments and with no CNS involvement.
* Complete MRD response (primary endpoint full analysis set); 82% and 71 o/o of patients in
CRl and CR2 respectively achieved MRD negativity. This phase 11 trial enrolled evוfpatients with Ph+ MRD+ B-ALL in CR2 or CR3, three of them achieved MRD negativity.4·5
** Key secondary endpoint full analysis set. Median OS 38,9 months for MRD complete responders (N=85) vs 121 6 months for MRD non-responders (N=22).5
† This phase 11 trial enrolled two patients with MRD+ B-ALL in CR3, one of them achieved MRD negativity and is included in the subgroup of MRD complete responders and in the subgroup of patients in CR2.4·5
‡ Seventy-four (67%) of 110 patients in the key secondary endpoint full analysis set
underwent HSCT: 73% and 54o/o of patients in CRl and CR2 respectively underwent ,HSCT†,5
B-ALL = B-precursor acute lymphoblastic leukaemia; CDl 9+ = CDl 9-positive; CRl, CR2 or
CR3 = fוrst1 second or third complete remission; HSCT = haematopoietic stem cell transplant; MRD = minimal residual disease; NR = not reached; OS = overall survival; Ph- or Ph+ = Ph iladelphia chromosome-negative or -positive.
REFERENCES
1. Gokbuget N, et al. Blood 2012;120(9):1868-1876; 2. Berry DA, et al. JAMA Oncol 2017;3(7):el 70580; 3. BrUggemann M and Kotrova M. Blood Adv 2017;1 (25):2456-2466; 4. BLINCYTO@ (blinatumomab) Summary of Product Characte1-istics; 5. Gokbuget N, et al. Blood 2018;131 (14):ו 522-ו 531.
For full details please refer to the PI as approved by the IL MoH
Amgen Europe B.V., Israel Branch