Tisagenlecleucel | Kymriah | Cells dispersion for infusion | - | Treatment of patients between two to 25 years of age (both ages inclusive), with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse, who also satisfy the requirements below:
if the patient is <16 years of age, that patient is assessed to have a Lansky performance status of ≥50;
if the patient is ≥16 years of age, that patient is assessed to have a Karnofsky performance status of ≥50;
if the patient has Philadelphia-positive (PH+) B-cell ALL, that patient must:
(i) be assessed to be intolerant to tyrosine kinase inhibitor (TKI) therapy;
(ii) have failed at least two lines of TKI therapy; or
(iii) be assessed to be contraindicated for TKI therapy;
the patient must have been assessed according to a morphologic assessment to have ≥5% lymphoblasts and CD19 ALL positivity in the patient’s bone marrow;
the patient must not have any of the following:
(i) isolated extramedullary ALL relapse;
(ii) any uncontrolled infection, including but not limited to HIV, active hepatitis B or active hepatitis C;
(iii) any active central nervous system (CNS) involvement by ALL;
(iv) any uncontrolled secondary CNS disease; or
(v) any secondary CNS disease that is anticipated to be uncontrolled at the time of lymphocyte infusion;
the patient must have sufficient organ function (e.g. renal, cardiac, and pulmonary function); and
the patient must not have received any prior chimeric antigen receptor T-cell (CAR-T) treatments for B-cell ALL.
Treatment of patients 18 years of age and above with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, who also satisfy the requirements below:
the patient must have failed or is ineligible for hematopoietic stem cell transplant;
the patient must have an Eastern Cooperative Oncology Group (“ECOG”) performance status of 0 or 1;
the patient must not have any of the following:
(i) any uncontrolled infection, including but not limited to HIV, active hepatitis B, or active hepatitis C;
(ii) any primary central nervous system (CNS) DLBCL;
(iii) any uncontrolled secondary CNS disease; or
(iv) any secondary CNS disease that is anticipated to be uncontrolled at the time of lymphocyte infusion;
the patient must have sufficient organ function (e.g. renal, cardiac, and pulmonary function); and
the patient must not have received any prior chimeric antigen receptor T-cell (CAR-T) treatments for DLBCL.
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*The CTGTP availability at each healthcare institution varies, depending on the clinical conditions commonly managed by the institution and the drugs usually prescribed by the doctors. |
