Keytruda

As a single agent to treat locally advanced or metastatic urothelial carcinoma: in patients who are ineligible for any platinum-containing chemotherapy; or in those who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. In combination with enfortumab vedotin to treat locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy. As a single agent to treat patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. In combination with axitinib or lenvatinib for the first-line treatment of advanced renal cell carcinoma (RCC). Adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

Unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) as determined by an FDA-approved test. In combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. Locally advanced or metastatic esophageal or GEJ (tumors with epicenter 1–5cm above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation, either in combination with platinum- and fluoropyrimidine-based chemotherapy, or as a single agent after ≥1 prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test. Hepatocellular carcinoma (HCC) in patients previously treated with sorafenib.

In combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test. As a single agent for recurrent or metastatic cervical cancer in patients with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test. In combination with lenvatinib, for advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not microsatellite instability-high (MSI-H), in patients with disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. As a single agent for advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, in patients with disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

In combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. In combination with carboplatin and either paclitaxel or paclitaxel protein-bound for the first-line treatment of patients with metastatic squamous NSCLC. As a single agent for the first-line treatment of Stage III NSCLC in patients who are not candidates for surgical resection or definitive chemoradiation, or metastatic, and whose tumors express PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. As a single agent for the treatment of metastatic NSCLC in patients whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy; patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda. As a single agent for adjuvant treatment following resection and platinum-based chemotherapy in adults with Stage IB (T2a ≥4cm), II, or IIIA NSCLC. 

Unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior therapy and have no satisfactory alternative treatments. Unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior therapy and have no satisfactory alternative treatments.