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

bayer australia ltd - larotrectinib sulfate, quantity: 30.7 mg - capsule, hard - excipient ingredients: gelatin; propylene glycol; dimethicone 12500; brilliant blue fcf aluminium lake; titanium dioxide; shellac; strong ammonia solution - vitrakvi (larotrectinib) has provisional approval in australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:,? have a neurotrophic tyrosine receptor kinase (ntrk) gene fusion without a known acquired resistance mutation, ? are metastatic or where surgical resection is likely to result in severe morbidity, and ? have either progressed following treatment or who have no satisfactory alternative therapy. the decision to approve this indication has been made on the basis of objective response rate (orr) and duration of response from single arm clinical studies. the sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.

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

bayer australia ltd - larotrectinib sulfate, quantity: 24.6 mg/ml - oral liquid, solution - excipient ingredients: sodium citrate dihydrate; hydroxypropylbetadex; purified water; flavour; sorbitol; methyl hydroxybenzoate; citric acid; sucrose; glycerol; monobasic sodium phosphate; potassium sorbate - vitrakvi (larotrectinib) has provisional approval in australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:,? have a neurotrophic tyrosine receptor kinase (ntrk) gene fusion without a known acquired resistance mutation, ? are metastatic or where surgical resection is likely to result in severe morbidity, and ? have either progressed following treatment or who have no satisfactory alternative therapy. the decision to approve this indication has been made on the basis of objective response rate (orr) and duration of response from single arm clinical studies. the sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.

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

bayer australia ltd - larotrectinib sulfate, quantity: 24.6 mg/ml - oral liquid, solution - excipient ingredients: sodium citrate; hydroxypropylbetadex; purified water; sucralose; sodium benzoate; citric acid; flavour - vitrakvi (larotrectinib) has provisional approval in australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:,? have a neurotrophic tyrosine receptor kinase (ntrk) gene fusion without a known acquired resistance mutation, ? are metastatic or where surgical resection is likely to result in severe morbidity, and ? have either progressed following treatment or who have no satisfactory alternative therapy. the decision to approve this indication has been made on the basis of objective response rate (orr) and duration of response from single arm clinical studies. the sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.

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

bayer australia ltd - larotrectinib sulfate, quantity: 122.9 mg - capsule, hard - excipient ingredients: titanium dioxide; shellac; gelatin; dimethicone 12500; propylene glycol; brilliant blue fcf aluminium lake; strong ammonia solution - vitrakvi (larotrectinib) has provisional approval in australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:,? have a neurotrophic tyrosine receptor kinase (ntrk) gene fusion without a known acquired resistance mutation, ? are metastatic or where surgical resection is likely to result in severe morbidity, and ? have either progressed following treatment or who have no satisfactory alternative therapy. the decision to approve this indication has been made on the basis of objective response rate (orr) and duration of response from single arm clinical studies. the sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.

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

loxo oncology, inc. - larotrectinib (unii: pf9462i9hx) (larotrectinib - unii:pf9462i9hx) - vitrakvi is indicated for the treatment of adult and pediatric patients with solid tumors that: 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 confirmatory trials. none. risk summary based on literature reports in human subjects with congenital mutations leading to changes in trk signaling, findings from animal studies, and its mechanism of action [see clinical pharmacology (12.1)] , vitrakvi can cause embryo-fetal harm when administered to a pregnant woman. there are no available data on vitrakvi use in pregnant women. administration of larotrectinib to pregnant rats and rabbits during the period of organogenesis resulted in malformations at maternal exposures that were approximately 11- and 0.7-times, respectively, those observed at the clinical dose of 100 mg twice daily (see data) . advise pregnant wo

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

bayer healthcare pharmaceuticals inc. - larotrectinib (unii: pf9462i9hx) (larotrectinib - unii:pf9462i9hx) - vitrakvi is indicated for the treatment of adult and pediatric patients with solid tumors that: select patients for therapy based on an fda-approved test [see dosage and administration (2.1)]. 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 confirmatory trials. none. risk summary based on literature reports in human subjects with congenital mutations leading to changes in trk signaling, findings from animal studies, and its mechanism of action [see clinical pharmacology (12.1)] , vitrakvi can cause embryo-fetal harm when administered to a pregnant woman. there are no available data on vitrakvi use in pregnant women. administration of larotrectinib to pregnant rats and rabbits during the period of organogenesis resulted in malformations at maternal exposures that were approximately 11- and 0.7-times, respec

Canada - English - Health Canada

bayer inc - larotrectinib (larotrectinib sulfate) - capsule - 25mg - larotrectinib (larotrectinib sulfate) 25mg - antineoplastic agents

Canada - English - Health Canada

bayer inc - larotrectinib (larotrectinib sulfate) - capsule - 100mg - larotrectinib (larotrectinib sulfate) 100mg - antineoplastic agents

Canada - English - Health Canada

bayer inc - larotrectinib (larotrectinib sulfate) - solution - 20mg - larotrectinib (larotrectinib sulfate) 20mg - antineoplastic agents

Israel - English - Ministry of Health

bayer israel ltd - larotrectinib as sulfate - solution (oral) - larotrectinib as sulfate 20 mg/ml - larotrectinib - vitrakvi as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,• who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and• who have no satisfactory treatment options