Cell, Tissue and Gene Therapy Product (CTGTP) List

Axicabtagene ciloleucel

Yescarta

Suspension for intravenous infusion

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1. Treatment of patients 18 years of age and above with diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy, and who are intended for transplant, who also satisfy the requirements below:

   • the patient must have had first-line therapy including (at a minimum):

     1. an anti-CD20 monoclonal antibody unless the investigator determined that the tumour was CD20-negative; and

     2. an anthracycline-containing chemotherapy regimen (or equivalent);

   • the patient must have DLBCL or HGBCL that includes the following types defined by the World Health Organization in 2016:

     1. DLBCL not otherwise specified (including activated B-cell type or germinal centre B-cell type)

     2. HGBCL with or without MYC and BCL2 and/or BCL6 rearrangements

     3. DLBCL arising from follicular lymphoma

     4. T-cell/histiocyte-rich LBCL

     5. DLBCL associated with chronic inflammation

     6. Primary cutaneous DLBCL, leg type

     7. Epstein-Barr virus-positive DLBCL;

   • 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:

     1. any uncontrolled infection, including but not limited to HIV, active hepatitis B or active hepatitis C;

     2. any primary central nervous system (CNS) DLBCL or HGBCL;

     3. any uncontrolled secondary CNS disease; or

     4. 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 or HGBCL.

2. Treatment of patients 18 years of age and above with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma, who also satisfy the requirements below:

   • the patient must have failed or is ineligible for haematopoietic 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:

     1. any uncontrolled infection, including but not limited to HIV, active hepatitis B or active hepatitis C;

     2. any primary central nervous system (CNS) LBCL;

     3. any uncontrolled secondary CNS disease; or

     4. 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 LBCL.

Tisagenlecleucel

Kymriah

Cells dispersion for infusion

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1. 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:

     1. be assessed to be intolerant to tyrosine kinase inhibitor (TKI) therapy;

     2. have failed at least two lines of TKI therapy; or

     3. 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:

     1. isolated extramedullary ALL relapse;

     2. any uncontrolled infection, including but not limited to HIV, active hepatitis B or active hepatitis C;

     3. any active central nervous system (CNS) involvement by ALL;

     4. any uncontrolled secondary CNS disease; or

     5. 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.

2. 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 haematopoietic 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:

     1. any uncontrolled infection, including but not limited to HIV, active hepatitis B or active hepatitis C;

     2. any primary central nervous system (CNS) DLBCL;

     3. any uncontrolled secondary CNS disease; or

     4. 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.