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

janssen-cilag pty ltd - amivantamab, quantity: 350 mg - injection, concentrated - excipient ingredients: methionine; disodium edetate; histidine; polysorbate 80; histidine hydrochloride monohydrate; water for injections; sucrose - rybrevant has provisional approval for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) that has an activating epidermal-growth factor receptor (egfr) exon 20 insertion mutation, whose disease has progressed on or after platinum-based chemotherapy.,the decision to approve this indication has been made on the basis of objective response rate and duration of response in a single arm study. continued approval of this indication depends on verification and description of benefit in a confirmatory study.

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

janssen biotech, inc. - amivantamab (unii: 0jsr7z0nb6) (amivantamab - unii:0jsr7z0nb6) - rybrevant is indicated in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with epidermal growth factor receptor (egfr) exon 20 insertion mutations, as detected by an fda-approved test [see dosage and administration (2.2)] . rybrevant is indicated as a single agent for the treatment of adult patients with locally advanced or metastatic nsclc with egfr exon 20 insertion mutations, as detected by an fda-approved test [see dosage and administration (2.2)] , whose disease has progressed on or after platinum-based chemotherapy. none. risk summary based on the mechanism of action and findings in animal models, rybrevant can cause fetal harm when administered to a pregnant woman. there are no available data on the use of rybrevant in pregnant women or animal data to assess the risk of rybrevant in pregnancy. disruption or depletion of egfr in animal models resulted in impairment of embryo-fetal development including effects on placental, lung, cardiac, skin, and neural development. the absence of egfr or met signaling has resulted in embryo lethality, malformations, and post-natal death in animals ( see data ) . 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 no animal studies have been conducted to evaluate the effects of amivantamab-vmjw on reproduction and fetal development; however, based on its mechanism of action, rybrevant can cause fetal harm or developmental anomalies. in mice, egfr is critically important in reproductive and developmental processes including blastocyst implantation, placental development, and embryo-fetal/postnatal survival and development. reduction or elimination of embryo-fetal or maternal egfr signaling can prevent implantation, can cause embryo-fetal loss during various stages of gestation (through effects on placental development) and can cause developmental anomalies and early death in surviving fetuses. adverse developmental outcomes were observed in multiple organs in embryos/neonates of mice with disrupted egfr signaling. similarly, knock out of met or its ligand hgf was embryonic lethal due to severe defects in placental development, and fetuses displayed defects in muscle development in multiple organs. human igg1 is known to cross the placenta; therefore, amivantamab-vmjw has the potential to be transmitted from the mother to the developing fetus. risk summary there are no data on the presence of amivantamab-vmjw in human milk, the effects on the breastfed child or on milk production. because of the potential for serious adverse reactions from rybrevant in breast-fed children, advise women not to breast-feed during treatment with rybrevant and for 3 months after the last dose. rybrevant can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)]. pregnancy testing verify pregnancy status of females of reproductive potential prior to initiating rybrevant. contraception females advise females of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of rybrevant. the safety and efficacy of rybrevant have not been established in pediatric patients. of the 151 patients with locally advanced or metastatic nsclc treated with rybrevant in combination with carboplatin and pemetrexed in the papillon study, 37% were ≥65 years of age and 8% were ≥75 years of age. of the 302 patients with locally advanced or metastatic nsclc treated with rybrevant as a single agent in the chrysalis study, 39% were ≥65 years of age and 11% were ≥75 years of age. no clinically important differences in safety or efficacy were observed between patients who were ≥65 years of age and younger patients.

Israel - English - Ministry of Health

j-c health care ltd - amivantamab - concentrate for solution for infusion - amivantamab 350 mg / 7.0 ml - amivantamab - rybrevant is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with epidermal growth factor receptor (egfr) exon 20 insertion mutation, as detected by an approved test whose disease has progressed on or after platinum-based chemotherapy.

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v.    - amivantamab - carcinoma, non-small-cell lung - antineoplastic agents - rybrevant as monotherapy is indicated for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating epidermal growth factor receptor (egfr) exon 20 insertion mutations, after failure of platinum-based chemotherapy.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

johnson & johnson sdn. bhd. - amivantamab -

Canada - English - Health Canada

janssen inc - amivantamab - solution - 350mg - amivantamab 350mg

Singapore - English - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - amivantamab - infusion, solution concentrate - amivantamab 350mg/7ml

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - amivantamab 50 mg/ml - concentrate for infusion - active: amivantamab 50 mg/ml excipient: disodium edetate dihydrate histidine histidine hydrochloride monohydrate methionine polysorbate 80 sucrose water for injection - rybrevant has provisional approval for the treatment of adults patients with locally advanced or metastatic non-small cell lung cancer (nsclc) that has an activating epidermal-growth factor receptor (egfr) exon 20 insertion mutation whose disease has progressed on or after platinum-based chemotherapy.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

janssen-cilag ltd - amivantamab - solution for infusion - 50mg/1ml

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: johnson & johnson (philippines), inc.; distributor: johnson & johnson (philippines), inc. - amivantamab - concentrate for solution for infusion (iv) - 350 mg/7 ml (50mg/ml)