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

morphosys us inc. - tafasitamab (unii: qqa9mlh692) (tafasitamab - unii:qqa9mlh692) - monjuvi, in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) not otherwise specified, including dlbcl arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (asct). this indication is approved under accelerated approval based on overall response rate [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). none. risk summary based on its mechanism of action, monjuvi may cause fetal b-cell depletion when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on monjuvi use in pregnant women to evaluate for a drug-associated risk. animal reproductive toxicity studies have not been conducted with tafasitamab-cxix. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically

European Union - English - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - tafasitamab - lymphoma, large b-cell, diffuse - antineoplastic agents - minjuvi is indicated in combination with lenalidomide followed by minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) who are not eligible for autologous stem cell transplant (asct).

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

specialised therapeutics alim pty ltd - tafasitamab, quantity: 200 mg - injection, powder for - excipient ingredients: polysorbate 20; citric acid monohydrate; trehalose dihydrate; sodium citrate dihydrate - minjuvi is indicated in combination with lenalidomide followed by minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) who are not eligible for autologous stem cell transplant (asct).,this indication was approved via the provisional approval pathway, based on objective response rate and duration of response in a single arm trial. continued approval for this indication depends on verification and description of clinical benefit in a confirmatory trial.

Israel - English - Ministry of Health

medison pharma ltd - tafasitamab - powder for concentrate for solution for infusion - tafasitamab 200 mg - tafasitamab - minjuvi is indicated in combination with lenalidomide followed by minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl) who are not eligible for autologous stem cell transplant (asct).

Canada - English - Health Canada

incyte corporation - tafasitamab - powder for solution - 200mg - tafasitamab 200mg - antineoplastic agents

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

incyte biosciences international sarl, switzerland - tafasitamab - powder for concentrate for solution for infusion - 200 mg,

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

y-mabs therapeutics, inc. - naxitamab (unii: 9k8gnj2874) (naxitamab - unii:9k8gnj2874) - danyelza is indicated, in combination with granulocyte-macrophage colony-stimulating factor (gm-csf), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. this indication is approved under accelerated approval based on overall response rate and duration 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(s). danyelza is contraindicated in patients with a history of severe hypersensitivity reaction to naxitamab-gqgk. reactions have included anaphylaxis [see warnings and precautions (5.1)] . risk summary based on its mechanism of action, danyelza may cause fetal harm when administered to pregnant women [see clinical pharmacology (12.1) ]. there are no available data on the use of danyelza in pregnant women and no animal reproduction studies have been conducted with danyelza. igg1 monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester. advise pregnant women of potential risk to a fetus. 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 are no data on the presence of naxitamab-gqgk in human milk or its effects on the breastfed child, or on milk production, however, human igg is present in human milk. because of the potential for serious adverse reactions in a breastfed child from danyelza, advise women not to breastfeed during treatment and for 2 months after the last dose of danyelza. danyelza may cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating danyelza. contraception females advise females of reproductive potential to use effective contraception during treatment and for 2 months after the last dose of danyelza. the safety and effectiveness of danyelza, in combination with gm-csf for the treatment of relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response or stable disease following prior therapy, have been established in pediatric patients 1 year of age and older. safety and effectiveness have not been established in pediatric patients younger than 1 year of age. neuroblastoma is largely a disease of pediatric and young adult patients. clinical studies of danyelza in combination with gm-csf did not include patients 65 years of age and older.

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v. - talquetamab - multiple myeloma - antineoplastic agents - talvey is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti cd38 antibody and have demonstrated disease progression on the last therapy.,

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

janssen biotech, inc. - talquetamab (unii: 4w3kfi3tn3) (talquetamab - unii:4w3kfi3tn3) - talvey is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-cd38 monoclonal antibody. this indication is approved under accelerated approval based on 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(s). none. risk summary based on the mechanism of action, talvey may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on the use of talvey in pregnant women to evaluate for a drug associated risk. no animal reproductive or developmental toxicity studies have been conducted with talquetamab-tgvs. talquetamab-tgvs causes t-cell activation and cytokine release; immune activation may compromise pregna

Israel - English - Ministry of Health

takeda israel ltd - naxitamab - concentrate for solution for infusion - naxitamab 4 mg / 1 ml - danyelza is indicated, in combination with granulocyte-macrophage colony-stimulating factor (gm-csf), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.