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

eli lilly and company - selpercatinib (unii: cegm9ybngd) (selpercatinib - unii:cegm9ybngd) - retevmo® is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with a rearranged during transfection (ret) gene fusion, as detected by an fda-approved test. retevmo is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (mtc) with a ret mutation, as detected by an fda-approved test, who require systemic therapy. this indication is approved under accelerated approval based on overall response rate and duration of response [see clinical studies (14.2)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). retevmo is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a ret gene fusion, as detected by an fda-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). this indication is approved under accelerated approval based on overall response rate and duration of response [see clinical studies (14.3)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). retevmo is indicated for the treatment of adult patients with locally advanced or metastatic solid tumors with a ret gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. this indication is approved under accelerated approval based on overall response rate and duration of response [see clinical studies (14.4)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). none. risk summary based on findings from animal studies, and its mechanism of action [see clinical pharmacology (12.1)] , retevmo can cause fetal harm when administered to a pregnant woman. there are no available data on retevmo use in pregnant women to inform drug-associated risk. administration of selpercatinib to pregnant rats during the period of organogenesis resulted in embryolethality and malformations at maternal exposures that were approximately equal to the human exposure at the clinical dose of 160 mg twice daily. advise pregnant women of the 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. data animal data selpercatinib administration to pregnant rats during the period of organogenesis at oral doses ≥100 mg/kg [approximately 3.6 times the human exposure based on the area under the curve (auc) at the clinical dose of 160 mg twice daily] resulted in 100% post-implantation loss. at the dose of 50 mg/kg [approximately equal to the human exposure (auc) at the clinical dose of 160 mg twice daily], 6 of 8 females had 100% early resorptions; the remaining 2 females had high levels of early resorptions with only 3 viable fetuses across the 2 litters. all viable fetuses had decreased fetal body weight and malformations (2 with short tail and one with small snout and localized edema of the neck and thorax). risk summary there are no data on the presence of selpercatinib or its metabolites in human milk or on their effects on the breastfed child or on milk production. because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with retevmo and for 1 week after the last dose. based on animal data, retevmo can cause embryolethality and malformations at doses resulting in exposures less than or equal to the human exposure at the clinical dose of 160 mg twice daily [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating retevmo [see use in specific populations (8.1)] . contraception females advise female patients of reproductive potential to use effective contraception during treatment with retevmo and for 1 week after the last dose. males advise males with female partners of reproductive potential to use effective contraception during treatment with retevmo and for 1 week after the last dose. infertility retevmo may impair fertility in females and males of reproductive potential [see use in specific populations (8.4), nonclinical toxicology (13.1)] . the safety and effectiveness of retevmo have been established in pediatric patients aged 12 years and older for medullary thyroid cancer (mtc) who require systemic therapy and for advanced ret fusion-positive thyroid cancer who require systemic therapy and are radioactive iodine-refractory (if radioactive iodine is appropriate). use of retevmo for these indications is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged 12 years and older [see adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.2, 14.3)] . the safety and effectiveness of retevmo have not been established in these indications in patients less than 12 years of age. the safety and effectiveness of retevmo have not been established in pediatric patients for other indications [see indications and usage (1)] . juvenile animal toxicity data in a juvenile rat toxicity study, animals were dosed daily with selpercatinib from post-natal day 21 to day 70 (approximately equivalent to a human child to late adolescent). selpercatinib increased physeal thickness of multiple bones, extending into the metaphysis and associated with decreased trabecular bone, which was not reversible at doses approximately equivalent to or greater than the adult human exposure at the clinical dose of 160 mg twice daily. growth plate changes were associated with impairment of bone modeling, resulting in decreased femur length and with reduction in bone mineral density. selpercatinib also induced reversible hypocellularity of bone marrow in males at ≥30 mg/kg (approximately equivalent to or greater than the adult human exposure at the clinical dose of 160 mg twice daily), and reversible alterations of dentin composition at ≥50 mg/kg (approximately 3 times the adult human exposure at the clinical dose of 160 mg twice daily). irreversible, dose-dependent degeneration of testicular germinal epithelium, with vacuolation of sertoli cells and corresponding depletion of spermatozoa in the epididymides, was also observed at ≥ 30 mg/kg (approximately equivalent to or greater than the adult human exposure at the clinical dose of 160 mg twice daily) and affected male reproductive performance at 50 mg/kg (approximately 3 times the adult human exposure at the clinical dose of 160 mg twice daily). females exhibited delay in attainment of vaginal patency, a marker of sexual maturity, at 125 mg/kg (approximately 4 times the adult human exposure at the clinical dose of 160 mg twice daily); this affect was associated with lower mean body weight. similar effects in irregular thickening of growth plates in adult rats and minipigs, and tooth dysplasia and malocclusion, resulting in tooth loss in adult rats were observed in repeat dose studies of up to 13-week duration with selpercatinib. monitor growth plates in adolescent patients with open growth plates. consider interrupting or discontinuing therapy based on the severity of any growth plate abnormalities and based on an individual risk-benefit assessment. of 796 patients who received retevmo, 34% (268 patients) were ≥65 years of age and 9% (74 patients) were ≥75 years of age. no overall differences were observed in the safety or effectiveness of retevmo between patients who were ≥65 years of age and younger patients. no dosage modification is recommended for patients with mild to severe renal impairment [estimated glomerular filtration rate (egfr) ≥15 to 89 ml/min, estimated by modification of diet in renal disease (mdrd) equation]. the recommended dosage has not been established for patients with end-stage renal disease (esrd) [see clinical pharmacology (12.3)] . reduce the dose when administering retevmo to patients with severe [total bilirubin greater than 3 to 10 times upper limit of normal (uln) and any ast] hepatic impairment [see dosage and administration (2.7)] . no dosage modification is recommended for patients with mild (total bilirubin less than or equal to uln with ast greater than uln or total bilirubin greater than 1 to 1.5 times uln with any ast) or moderate (total bilirubin greater than 1.5 to 3 times uln and any ast) hepatic impairment. monitor for retevmo-related adverse reactions in patients with hepatic impairment [see clinical pharmacology (12.3)] .

Israel - English - Ministry of Health

eli lilly israel ltd, israel - selpercatinib - capsules - selpercatinib 40 mg - selpercatinib - • metastatic ret fusion-positive non-small cell lung cancerretevmo™ is indicated for the treatment of adult patients with metastatic ret fusion-positive non-small cell lung cancer (nsclc).• ret-mutant medullary thyroid cancerretevmo is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret-mutant medullary thyroid cancer (mtc) who require systemic therapy.• ret fusion-positive thyroid cancerretevmo is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

Israel - English - Ministry of Health

eli lilly israel ltd, israel - selpercatinib - capsules - selpercatinib 80 mg - selpercatinib - • metastatic ret fusion-positive non-small cell lung cancerretevmo™ is indicated for the treatment of adult patients with metastatic ret fusion-positive non-small cell lung cancer (nsclc).• ret-mutant medullary thyroid cancerretevmo is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret-mutant medullary thyroid cancer (mtc) who require systemic therapy.• ret fusion-positive thyroid cancerretevmo is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

European Union - English - EMA (European Medicines Agency)

eli lilly nederland b.v. - selpercatinib - carcinoma, non-small-cell lung; thyroid neoplasms - antineoplastic agents - retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced ret-mutant medullary thyroid cancer (mtc)advanced ret fusion-positive non-small cell lung cancer (nsclc) not previously treated with a ret inhibitoradvanced ret fusion-positive thyroid cancer who require systematic therapy following prior treatment

Canada - English - Health Canada

loxo oncology inc - selpercatinib - capsule - 40mg - selpercatinib 40mg - antineoplastic agents

Canada - English - Health Canada

loxo oncology inc - selpercatinib - capsule - 80mg - selpercatinib 80mg - antineoplastic agents

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

eli lilly australia pty ltd - selpercatinib, quantity: 40 mg - capsule, hard - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; titanium dioxide; gelatin; iron oxide black; propylene glycol; butan-1-ol; purified water; isopropyl alcohol; shellac; ethanol absolute; ammonia; potassium hydroxide - retevmo has provisional approval for the treatment of adult patients with locally advanced or metastatic ret fusion positive non-small cell lung cancer (nsclc).,the decision to approve this indication has been made on the basis of objective response rate (orr) and duration of response (dor) from a single arm study. continued approval of this indication depends on verification and description of benefit in a confirmatory trial.

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

eli lilly australia pty ltd - selpercatinib, quantity: 80 mg - capsule, hard - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; titanium dioxide; brilliant blue fcf; gelatin; propylene glycol; butan-1-ol; purified water; isopropyl alcohol; shellac; ethanol absolute; iron oxide black; ammonia; potassium hydroxide - retevmo has provisional approval for the treatment of adult patients with locally advanced or metastatic ret fusion positive non-small cell lung cancer (nsclc).,the decision to approve this indication has been made on the basis of objective response rate (orr) and duration of response (dor) from a single arm study. continued approval of this indication depends on verification and description of benefit in a confirmatory trial.

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

eli lilly and company, united states - selpercatinib - capsule - 40 mg

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

eli lilly and company, united states - selpercatinib - capsule - 80 mg