Lenvatinib

Differentiated Thyroid Carcinoma (DTC) LENVIMA as monotherapy is indicated for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).

1). Endometrial Carcinoma (EC) LENVIMA in combination with pembrolizumab is indicated for the treatment of adult patients with advanced or recurrent endometrial carcinoma (EC) who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery or radiation.

, Additional Safety Information from 1L mRCC LENVIMA + Pembrolizumab Clinical Trial Experience, Geriatrics). Although no overall difference in effectiveness was observed between elderly and younger patients treated with LENVIMA + everolimus in the pivotal RCC Phase 2 study, the following common adverse LENVIMA® lenvatinib capsules Page 31 of 106 events occurred at higher rates in patients 65 years of age or greater as compared to younger subjects: cough, dyspnea, lethargy, nausea, peripheral swelling and vomiting.

Elderly patients should be treated with caution and monitored for signs of toxicity. HCC patients of age ≥75 years appear to have demonstrated reduced tolerability to LENVIMA and were more likely to experience hypertension, proteinuria, decreased appetite, asthenia, dehydration, dizziness and hepatic encephalopathy.

Arterial thromboembolic events also occurred at an increased incidence in this age group (see 7 Warnings and Precautions, Cardiovascular, Arterial Thromboembolism). 8. 1. Adverse Reaction Overview The safety data for DTC described below are derived from the pivotal DTC Phase 3 SELECT trial which randomized (2:1) patients with radioactive iodine-refractory differentiated thyroid cancer to LENVIMA (n=261) or placebo (n=131).

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