United States - English - 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.

European Union - English - EMA (European Medicines Agency)

janssen-cilag international nv - ciltacabtagene autoleucel - multiple myeloma - carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - ciltacabtagene autoleucel, quantity: 500000 cells/kg - injection, intravenous infusion - excipient ingredients: dimethyl sulfoxide - cellular therapies - carvykti is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-cd38 antibody.

Canada - English - Health Canada

janssen inc - ciltacabtagene autoleucel - suspension - 100000000cells - ciltacabtagene autoleucel 100000000cells

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

janssen pharmaceutica n.v, belgium - ciltacabtagene autoleucel - intravenous infusion - 100000000 tu/ml, cel

European Union - English - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - idecabtagene vicleucel - multiple myeloma; neoplasms; cancer; neoplasms, plasma cell; hemostatic disorders; vascular diseases; cardiovascular diseases; paraproteinemias; blood protein disorders; hematologic diseases; hemic and lymphatic diseases; hemorrhagic disorders; infectious mononucleosis; lymphoproliferative disorders; immunoproliferative disorders; immune system diseases - antineoplastic agents - abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti cd38 antibody and have demonstrated disease progression on the last therapy.

Canada - English - Health Canada

celgene inc - idecabtagene vicleucel - suspension - 520000000cells - idecabtagene vicleucel 520000000cells - gene therapy

United States - English - NLM (National Library of Medicine)

juno therapeutics, inc. - lisocabtagene maraleucel (unii: 7k2yoj14x0) (lisocabtagene maraleucel - unii:7k2yoj14x0) - breyanzi is a cd19-directed genetically modified autologous t cell immunotherapy indicated for the treatment of adult patients with large b-cell lymphoma (lbcl), including diffuse large b-cell lymphoma (dlbcl) not otherwise specified (including dlbcl arising from indolent lymphoma), high-grade b-cell lymphoma, primary mediastinal large b-cell lymphoma, and follicular lymphoma grade 3b who have: limitations of use : breyanzi is not indicated for the treatment of patients with primary central nervous system (cns) lymphoma [see clinical studies (14)]. none. risk summary there are no available data with breyanzi use in pregnant women. no animal reproductive and developmental toxicity studies have been conducted with breyanzi to assess whether it can cause fetal harm when administered to a pregnant woman. it is not known if breyanzi 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 b-cell lymphocytopenia and hypogammaglobulinemia. therefore, breyanzi is not recommended for women who are pregnant, and pregnancy after breyanzi 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% to 4% and 15% to 20%, respectively. risk summary there is no information regarding the presence of breyanzi 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 breyanzi and any potential adverse effects on the breastfed infant from breyanzi 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 pregnancy test prior to starting treatment with breyanzi. contraception see the prescribing information for fludarabine and cyclophosphamide for information on the need for effective contraception in patients who receive lymphodepleting chemotherapy. there are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with breyanzi. infertility there are no data on the effects of breyanzi on fertility. the safety and efficacy of breyanzi have not been established in pediatric patients. in clinical trials of breyanzi, 111 (41%) of 268 patients with two or more prior lines of therapy for lbcl, and 89 (59%) of 150 patients with one prior line of therapy for lbcl, were 65 years of age or older; 27 (10%) and 28 (19%) were 75 years of age or older, respectively. no clinically important differences in safety or effectiveness of breyanzi were observed between patients aged ≥ 65 and younger patients.

United States - English - 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.