Rybrevant

In combination w/ carboplatin & pemetrexed for the treatment of adults w/ locally advanced or metastatic NSCLC w/ epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment w/ an EGFR tyrosine kinase inhibitor. In combination w/ carboplatin & pemetrexed for the 1st-line treatment of adults w/ locally advanced or metastatic NSCLC w/ EGFR exon 20 insertion mutations, as detected by a validated test. Single agent for the treatment of adults w/ locally advanced or metastatic NSCLC w/ EGFR exon 20 insertion mutations, as detected by a validated test, whose disease has progressed on or after platinum-based chemotherapy.

IV Administer Rybrevant initial dose as split infusion on days 1 & 2 of wk 1. In combination w/ carboplatin & pemetrexed (every 3-wk dosing) Administer pemetrexed infusion 1st, carboplatin infusion 2nd, & Rybrevant infusion last. Adult weighing ≥80 kg 1,750 mg wkly (total of 4 doses) from wk 1-4, then 2,100 mg every 3 wk starting at wk 7 onwards, <80 kg 1,400 mg wkly (total of 4 doses) from wk 1-4, then 1,750 mg every 3 wk starting at wk 7 onwards. As single agent (every 2-wk dosing) Adult weighing ≥80 kg 1,400 mg wkly (total of 5 doses) from wk 1-5, then every 2 wk starting at wk 7 onwards, <80 kg 1,050 mg wkly (total of 5 doses) from wk 1-5, then every 2 wk starting at wk 7 onwards.

Risk of infusion-related reactions (IRRs); severe & fatal ILD/pneumonitis; severe rash including TEN, dermatitis acneiform, pruritus, & dry skin; ocular toxicity including keratitis, blepharitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, eye pruritus, & uveitis. Premedicate w/ antihistamines, antipyretics, & glucocorticoids to reduce risk of IRRs. Monitor for signs & symptoms of IRRs during infusion. Interrupt infusion if IRR is suspected. Reduce infusion rate or permanently discontinue treatment based on severity of IRR. Monitor for new or worsening symptoms indicative of ILD/pneumonitis. Immediately w/hold treatment in case of suspected ILD/pneumonitis & permanently discontinue if ILD/pneumonitis is confirmed. Limit sun exposure during & for 2 mth after treatment. Promptly refer patients presenting w/ severe rash, atypical appearance or distribution, or lack of improvement w/in 2 wk to a dermatologist, & patients w/ new or worsening eye symptoms to an ophthalmologist. W/hold, reduce dose, or permanently discontinue treatment based on severity of dermatologic &/or ocular reaction. Can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use effective contraception during treatment & for 3 mth after the last dose. Do not breastfeed during treatment & for 3 mth after the last dose. Safety & efficacy have not been established in ped patients.

In combination w/ carboplatin & pemetrexed: Rash, nail toxicity, IRR, fatigue, nausea, stomatitis, constipation, edema, decreased appetite, musculoskeletal pain, vomiting, COVID-19. As single agent: Rash, IRR, paronychia, musculoskeletal pain, dyspnea, nausea, edema, cough, fatigue, stomatitis, constipation, vomiting, pruritus.

Targeted Cancer Therapy

L01FX18 - amivantamab ; Belongs to the class of other monoclonal antibodies and antibody drug conjugates. Used in the treatment of cancer.

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