Melanoma: Treatment of patients w/ unresectable or metastatic melanoma; stage IIB or IIC melanoma who have undergone complete resection in adult & ped ≥12 yr; adjuvant treatment of patients w/ melanoma w/ lymph node involvement who have undergone complete resection.
NSCLC: In combination w/ pemetrexed & platinum chemotherapy for the 1st-line treatment of patients w/ metastatic non-squamous NSCLC, w/ no EGFR or ALK genomic tumor aberrations; in combination w/ carboplatin & either paclitaxel or nab-paclitaxel for the 1st-line treatment of patients w/ metastatic squamous NSCLC; as monotherapy for the 1st-line treatment of patients w/ locally advanced/metastatic NSCLC whose tumors express PD-L1 w/ a ≥1% tumor proportion score (TPS) as determined by a validated test, w/ no EGFR or ALK genomic tumor aberrations; as monotherapy for the treatment of patients w/ advanced NSCLC whose tumors express PD-L1 w/ a ≥1% TPS as determined by a validated test & who have received platinum-containing chemotherapy. Patient w/ EGFR or ALK genomic tumor aberrations should have received prior therapy for these aberrations prior to receiving treatment; as monotherapy for the adjuvant treatment of patients w/ stage IB (T2a ≥4 cm), II or IIIA NSCLC who have undergone complete resection.
Small cell lung cancer (SCLC): Treatment of patients w/ locally advanced/metastatic SCLC who have received ≥2 prior lines of therapy.
Head & neck cancer: 1st-line treatment of patients w/ metastatic or unresectable recurrent head & neck squamous cell carcinoma (HNSCC) as monotherapy or in combination w/ platinum & 5-fluorouracil (5-FU) chemotherapy; treatment of patients w/ metastatic or unresectable recurrent HNSCC w/ disease progression on or after platinum-containing chemotherapy.
Classical Hodgkin lymphoma: Treatment of adult & ped w/ relapsed or refractory classical Hodgkin lymphoma (cHL).
Urothelial carcinoma: Treatment of patients w/ locally advanced/metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy & whose tumors express PD-L1 [combined +ve score (CPS) ≥10] as determined by a validated test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status; treatment of patients w/ locally advanced/metastatic urothelial carcinoma who have received platinum-containing chemotherapy; treatment of patients w/ Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) w/ carcinoma in-situ (CIS) w/ or w/o papillary tumors who are ineligible for or have elected not to undergo cystectomy.
Gastric cancer: 1st-line treatment of patients w/ locally advanced unresectable or metastatic HER2 +ve gastric or gastroesophageal junction (GEJ) adenocarcinoma in combination w/ trastuzumab, fluoropyrimidine- & platinum-containing chemotherapy; as monotherapy for treatment of recurrent locally advanced/metastatic gastric or GEJ adenocarcinoma whose tumors express PD-L1 [CPS ≥1] as determined by a validated test, w/ disease progression on or after ≥2 prior lines of therapy including fluoropyrimidine- & platinum-containing chemotherapy & if appropriate, HER2/neu-targeted therapy.
Esophageal cancer: 1st-line treatment of patients w/ locally advanced unresectable or metastatic carcinoma of the esophagus or GEJ in combination w/ platinum & fluoropyrimidine based chemotherapy; as monotherapy for the treatment of patients w/ recurrent locally advanced/metastatic esophageal cancer whose tumors express PD-L1 [combined +ve score (CPS) ≥10] as determined by a validated test, & who have received 1 prior line of systemic therapy; as monotherapy for the treatment of patients w/ recurrent locally advanced/metastatic esophageal cancer who have received ≥2 prior lines of systemic therapy.
Microsatellite instability-high cancer: Treatment of patients w/ advanced microsatellite instability-high (MSI-H) including mismatch repair deficient (dMMR), cancer who have received prior therapy.
CRC: 1st-line treatment of patients w/ unresectable or metastatic MSH-I or dMMR CRC.
Hepatocellular carcinoma: Treatment of patients w/ hepatocellular carcinoma (HCC) who have been previously treated w/ anti-angiogenic tyrosine kinase inhibitor (TKI).
Cervical cancer: Treatment of patients w/ persistent, recurrent or metastatic cervical cancer in combination w/ chemotherapy w/ or w/o bevacizumab; as monotherapy for treatment of patients w/ recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by a validated test, w/ disease progression on or after chemotherapy.
Renal cell carcinoma: 1st-line treatment of patients w/ advanced renal cell carcinoma (RCC) in combination w/ axitinib; 1st-line treatment of patients w/ advanced RCC in combination w/ lenvatinib; as monotherapy for adjuvant treatment of patients w/ RCC at intermediate-high or risk of recurrence following nephrectomy & resection of metastatic lesions.
Endometrial carcinoma: Treatment of patients w/ advanced endometrial carcinoma who have disease progression following prior systemic therapy in any setting & not candidates for curative surgery or radiation in combination w/ lenvatinib.
Tumor mutational burden-high cancer: Treatment of adult & ped w/ unresectable or metastatic tumor mutational burden-high (TMBH) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by a validated test, that have progressed following prior treatment & who have no satisfactory alternative treatment options. Triple -ve breast cancer: Treatment of patients w/ high-risk early-stage triple -ve breast cancer (TNBC) in combination w/ chemotherapy as neoadjuvant treatment, & then continued as monotherapy as adjuvant treatment after surgery; treatment of patients w/ locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CP ≥10) as determined by a validated test in combination w/ chemotherapy.