미국 - 영어 - NLM (National Library of Medicine)

celgene corporation - idecabtagene vicleucel (unii: 8px1x7ug4d) (idecabtagene vicleucel - unii:8px1x7ug4d) - abecma is a b-cell maturation antigen (bcma)-directed genetically modified autologous t cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-cd38 monoclonal antibody. none. risk summary there are no available data with abecma use in pregnant women. no animal reproductive and developmental toxicity studies have been conducted with abecma to assess whether it can cause fetal harm when administered to a pregnant woman. it is not known if abecma has the potential to be transferred to the fetus. based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including plasma cell aplasia or hypogammaglobulinemia. therefore, abecma is not recommended for women who are pregnant, and pregnancy after abecma infusion should be discussed with the treating physician. assess immunoglobulin levels in newborns of mothers treated with abecma. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. the estimated background risk in the u.s. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. risk summary there is no information regarding the presence of abecma in human milk, the effect on the breastfed infant, and the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for abecma and any potential adverse effects on the breastfed infant from abecma or from the underlying maternal condition. pregnancy testing pregnancy status of sexually active females with reproductive potential should be verified via pregnancy testing prior to starting treatment with abecma. contraception see the prescribing information for fludarabine and cyclophosphamide for information on the need for effective contraception in patients who receive the lymphodepleting chemotherapy. there are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with abecma. infertility there are no data on the effect of abecma on fertility. the safety and efficacy of abecma in patients under 18 years of age have not been established. in the clinical trials of abecma, 141 (40%) of the 349 patients were 65 years of age or older and 16/349 (4.6%) patients were 75 years of age or older. in karmma study, all five cases of grade 3 neurotoxicity occurred in patients ≥ 65 years of age (66 to 74 years). no clinically important differences in effectiveness of abecma were observed between these patients and patients younger than 65 years of age.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - brexucabtagene autoleucel, quantity: 1000000 cells/kg - injection, intravenous infusion - excipient ingredients: albumin; dimethyl sulfoxide; sodium chloride - cellular therapies - tecartus is a genetically modified autologous immunocellular therapy for the treatment of patients with relapsed or refractory mantle cell lymphoma (mcl), who have received two or more lines of therapy, including a btk inhibitor, unless ineligible or intolerant to treatment with a btk inhibitor.

미국 - 영어 - NLM (National Library of Medicine)

janssen biotech, inc - ciltacabtagene autoleucel (unii: 0l1f17908q) (ciltacabtagene autoleucel - unii:0l1f17908q) - carvykti (ciltacabtagene autoleucel) is a b-cell maturation antigen (bcma)-directed genetically modified autologous t cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least 1 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. none. risk summary there are no available data on the use of carvykti in pregnant women. no reproductive and developmental toxicity studies in animals have been conducted with carvykti to assess whether it can cause fetal harm when administered to a pregnant woman. it is not known whether carvykti has the potential to be transferred to the fetus and cause fetal toxicity. based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including b-cell lymphocytopenia and hypogammaglobulinemia. therefore, carvykti is not recommended for women who are pregnant, or for women of childbearing potential not using contraception. pregnant women should be advised that there may be risks to the fetus. pregnancy after carvykti therapy should be discussed with the treating physician. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively. risk summary there is no information regarding the presence of carvykti in human milk, the effect on the breastfed infant, and the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for carvykti and any potential adverse effects on the breastfed infant from carvykti or from the underlying maternal condition. pregnancy testing pregnancy status for females of child-bearing age should be verified prior to starting treatment with carvykti. contraception there are insufficient data to provide a recommendation concerning duration of contraception following treatment with carvykti. in clinical trials, female patients of childbearing potential were advised to practice a highly effective method of contraception and male patients with partners of childbearing potential or whose partners were pregnant were instructed to use a barrier method of contraception, until one year after the patient has received carvykti infusion. see the prescribing information for lymphodepleting chemotherapy for information on the need for contraception in patients who receive the lymphodepleting chemotherapy. infertility there are no data on the effect of carvykti on fertility. safety and effectiveness of carvykti in pediatric patients have not been established. of the 97 patients in cartitude-1 that received carvykti, 28% were 65 to 75 years of age, and 8% were 75 years of age or older. cartitude-1 did not include sufficient numbers of patients aged 65 and older to determine whether the effectiveness differs compared with that of younger patients. in 62 patients less than 65 years of age, all grade and grade 3 and higher neurologic toxicities occurred in 19% (12/62) and 6% (4/62), respectively. of the 35 patients ≥65 years of age, all grade and grade 3 and higher neurologic toxicities occurred in 37% (13/35) and 20% (7/35), respectively. of the 188 patients in cartitude-4 that received carvykti, 38% were 65 to 75 years of age, and 2% were 75 years of age or older. in 112 patients less than 65 years of age, all grade and grade 3 and higher neurologic toxicities occurred in 16% (18/112) and 3% (3/112) respectively. of the 76 patients ≥65 years of age, all grade and grade 3 and higher neurologic toxicities occurred in 34% (26/76) and 7% (5/76) respectively.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - axicabtagene ciloleucel, quantity: 1000000 cells/kg - injection, intravenous infusion - excipient ingredients: dimethyl sulfoxide; sodium chloride; albumin - cellular therapies - yescarta is a genetically modified autologous immunocellular therapy for the treatment of:large b-cell lymphoma - patients with relapsed or refractory large b-cell lymphoma (lbcl).yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. follicular lymphoma - patients with relapsed or refractory follicular lymphoma (fl) after two or more lines of systemic therapy.

유럽 연합 - 영어 - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - autologous cd34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin bb305 lentiviral vector encoding the beta-a-t87q-globin gene - beta-thalassemia - other hematological agents - zynteglo is indicated for the treatment of patients 12 years and older with transfusion-dependent β thalassaemia (tdt) who do not have a β0/β0 genotype, for whom haematopoietic stem cell (hsc) transplantation is appropriate but a human leukocyte antigen (hla)-matched related hsc donor is not available.

유럽 연합 - 영어 - EMA (European Medicines Agency)

fondazione telethon ets - autologous cd34+ enriched cell fraction that contains cd34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ada) cdna sequence from human haematopoietic stem/progenitor (cd34+) cells - severe combined immunodeficiency - immunostimulants, - strimvelis is indicated for the treatment of patients with severe combined immunodeficiency due to adenosine deaminase deficiency (ada-scid), for whom no suitable human leukocyte antigen (hla)-matched related stem cell donor is available (see section 4.2 and section 4.4).

미국 - 영어 - NLM (National Library of Medicine)

kite pharma, inc. - brexucabtagene autoleucel (unii: 4md2j2t8sj) (brexucabtagene autoleucel - unii:4md2j2t8sj) - tecartus is a cd19-directed genetically modified autologous t cell immunotherapy indicated for the treatment of: adult patients with relapsed or refractory mantle cell lymphoma (mcl). this indication is approved under accelerated approval based on overall response rate and durability of response [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. adult patients with relapsed or refractory b-cell precursor acute lymphoblastic leukemia (all). none. risk summary there are no available data with tecartus use in pregnant women. no animal reproductive and developmental toxicity studies have been conducted with tecartus to assess whether tecartus can cause fetal harm when administered to a pregnant woman. it is not known if tecartus has the potential to be transferred to the fetus. based on the mechanism of action of tecartus, if the transduced cells cross the placenta, they may cause fetal toxicity, including b cell lymphocytopenia. therefore, tecartus is not recommended for women who are pregnant. pregnancy after tecartus infusion should be discussed with the treating physician. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% – 4% and 15% – 20%, respectively. risk summary there is no information regarding the presence of tecartus in human milk, the effect on the breastfed infant, and the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tecartus and any potential adverse effects on the breastfed infant from tecartus or from the underlying maternal condition. pregnancy testing pregnancy status of females with reproductive potential should be verified. sexually active females of reproductive potential should have a negative pregnancy test prior to starting treatment with tecartus. contraception see the prescribing information for fludarabine and cyclophosphamide for information on the need for effective contraception in patients who receive the lymphodepleting chemotherapy. there are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with tecartus. infertility there are no data on the effect of tecartus on fertility. the safety and efficacy of tecartus have not been established in pediatric patients. of the 82 patients treated with tecartus for mcl, 42 (51%) were 65 years of age and over. of the 78 patients treated with tecartus for all, 12 (15%) were 65 years of age and over. no overall differences in safety or effectiveness were observed between these patients and younger patients.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - tisagenlecleucel -

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - tisagenlecleucel -

이스라엘 - 영어 - Ministry of Health

gilead sciences israel ltd - anti-cd19 car t cells - dispersion for infusion - anti-cd19 car t cells - acute lymphoblastic leukaemia tecartus is indicated for the treatment of adult patients with relapsed or refractory b-cell precursor acute lymphoblastic leukaemia (all).mantle cell lymphoma tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after two or more lines of systemic therapy including a bruton's tyrosine kinase (btk) inhibitor unless ineligible to btk inhibitor •limitation of use : tecartus is not indicated for the treatment of patients with active central nervous system lymphoma