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

verastem, inc. - duvelisib (unii: 610v23s0ji) (duvelisib - unii:610v23s0ji) - copiktra is indicated for the treatment of adult patients with relapsed or refractory cll or sll after at least two prior therapies. copiktra is indicated for the treatment of adult patients with relapsed or refractory fl after at least two prior systemic therapies. this indication is approved under accelerated approval based on overall response rate (orr) [see clinical studies ( 14.2)]; continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. none. risk summary based on findings from animal studies and the mechanism of action, copiktra can cause fetal harm when administered to a pregnant woman [see clinical pharmacology ( 12.1)] . there are no available data in pregnant women to inform the drug-associated risk. in animal reproduction studies, administration of duvelisib to pregnant rats and rabbits during organogenesis caused adverse deve

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

secura bio, inc. - duvelisib (unii: 610v23s0ji) (duvelisib - unii:610v23s0ji) - copiktra is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (cll) or small lymphocytic leukemia (sll) after at least two prior therapies. none. risk summary based on findings from animal studies and the mechanism of action, copiktra can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data in pregnant women to inform the drug-associated risk. in animal reproduction studies, administration of duvelisib to pregnant rats and rabbits during organogenesis caused adverse developmental outcomes including embryo-fetal mortality (resorptions, post-implantation loss, and decreased viable fetuses), alterations to growth (lower fetal weights) and structural abnormalities (malformations) at maternal doses 10 times and 39 times the mrhd of 25 mg bid in rats and rabbits, respectively (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

European Union - English - EMA (European Medicines Agency)

secura bio limited - duvelisib - leukemia, lymphocytic, chronic, b-cell; lymphoma, follicular - antineoplastic agents - copiktra monotherapy is indicated for the treatment of adult patients with: relapsed or refractory chronic lymphocytic leukaemia (cll) after at least two prior therapies. follicular lymphoma (fl) that is refractory to at least two prior  systemic therapies.

Israel - English - Ministry of Health

sanofi israel ltd - duvelisib - capsules - duvelisib - 15 mg - lurbinectedin - copiktra is a kinase inhibitor indicated for the treatment of adult patients with:• relapsed or refractory chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll) after at least two prior therapies.• relapsed or refractory follicular lymphoma (fl) after at least two prior systemic therapies.

Israel - English - Ministry of Health

sanofi israel ltd - duvelisib - capsules - duvelisib - 25 mg - lurbinectedin - copiktra is a kinase inhibitor indicated for the treatment of adult patients with:• relapsed or refractory chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll) after at least two prior therapies.• relapsed or refractory follicular lymphoma (fl) after at least two prior systemic therapies.

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

genzyme europe b.v., netherlands - duvelisib - capsule, hard - 25 mg

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

genzyme europe b.v., netherlands - duvelisib - capsule, hard - 15 mg

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

novartis pharmaceuticals australia pty ltd - alpelisib, quantity: 200 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; mannitol; sodium starch glycollate; hypromellose; magnesium stearate; purified talc; macrogol 4000; iron oxide black; iron oxide red; titanium dioxide - piqray in combination with fulvestrant, is indicated for the treatment of postmenopausal women, and men, with hormone receptor positive, her2-negative, advanced or metastatic breast cancer with a pik3ca mutation as detected by a validated test following progression on or after an endocrine-based regimen

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

novartis pharmaceuticals australia pty ltd - alpelisib, quantity: 200 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; mannitol; sodium starch glycollate; hypromellose; magnesium stearate; purified talc; macrogol 4000; iron oxide black; iron oxide red; titanium dioxide - piqray in combination with fulvestrant, is indicated for the treatment of postmenopausal women, and men, with hormone receptor positive, her2-negative, advanced or metastatic breast cancer with a pik3ca mutation as detected by a validated test following progression on or after an endocrine-based regimen

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

novartis pharmaceuticals australia pty ltd - alpelisib, quantity: 150 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; mannitol; sodium starch glycollate; hypromellose; magnesium stearate; purified talc; macrogol 4000; iron oxide black; iron oxide red; titanium dioxide - piqray in combination with fulvestrant, is indicated for the treatment of postmenopausal women, and men, with hormone receptor positive, her2-negative, advanced or metastatic breast cancer with a pik3ca mutation as detected by a validated test following progression on or after an endocrine-based regimen