Table 3.
Pembrolizumab.
| Indications | NCCN Guideline Category |
|---|---|
| Metastatic melanoma refractory to ipilimumab and BRAF inhibitor with BRAF mutation | 2A |
| Previously untreated advanced melanoma regardless of BRAF mutation status | 2A |
| Adjuvant treatment of lymph node(s)-positive melanoma following complete resection | 1 |
| Metastatic melanoma with limited resectability, if there is no disease after resection, as an adjuvant therapy | 2A |
| Metastatic non-small-cell lung cancer (NSCLC) that progressed after platinum-based therapy or, if appropriate, targeted therapy (EGFR/ALK mutation) and positive for PDL-1 | 1 |
| First-line treatment in patients with metastatic non-small-cell lung cancer with high PDL-1 expression (≥ 50%) but no EGFR or ALK mutation | 1 2B if PDL-1 1–49% |
| First-line treatment in combination with pemetrexed and carboplatin for metastatic non-squamous NSCLC without EGFR or ALK mutation, irrespective of PDL-1 expression | 1 |
| First-line treatment in metastatic squamous NSCLC in combination with carboplatin with paclitaxel/nab-paclitaxel regardless of PD-L1 status | 1 |
| First-line monotherapy in patients with stage 3 NSCLC who are not candidates for surgical resection as well as chemoradiation or metastatic NSCLC with PDL-1 expression ≥ 1% and no EGFR or ALK mutation | 1 |
| For recurrent or metastatic squamous cell cancer of head and neck (HNSCC) patients with progression on standard platinum-based therapy (non-nasopharyngeal—Category 1*; nasopharyngeal and PD-L1 positive—Category 2B*) | 1* 2B* |
| First-line therapy for patients with metastatic or unresectable, recurrent HNSCC either as monotherapy in patients whose tumor expresses PD-L1 (combined positive score ≥ 1%) or in combination with platinum and fluorouracil | 2A |
| Refractory adult and pediatric classical Hodgkin’s lymphoma | 2A |
| Unresectable or metastatic urothelial cancer with progression on or after platinum-based therapy including in the adjuvant setting | 2A |
| First-line therapy for unresectable or metastatic urothelial cancer patients who are ineligible for cisplatin-containing chemotherapy | 2A |
| Locally advanced or metastatic urothelial carcinoma patients who are not eligible for cisplatin-containing therapy and whose tumors express PD-L1 > 10%, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status | 2A |
| Unresectable or metastatic solid tumor patients with biomarker MSI-H or dMMR who have progressed after first-line therapy without satisfactory alternative therapy, irrespective of the location of the primary tumor | 2A |
| Third-line therapy for recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma patients with PD-L1 expression (combined positive score ≥ 1%) who have progressed on or after two or more prior lines of therapy including fluoropyrimidine and a platinum-based regimen and, if appropriate, HER2/neu-targeted therapy | 2A |
| Esophageal (squamous and adenocarcinoma) and EGJ adenocarcinoma, subsequent therapy for MSI-H or dMMR tumors; Category 2B for second-line therapy with PD-L1 expression ≥ 10% Category 2B for third-line or subsequent therapy | 2A |
| 2A | |
| Recurrent or metastatic cervical cancer progressing on or after chemotherapy and positive for PDL-1 | 2A |
| Refractory or relapsed primary mediastinal large B-cell lymphoma (PMBCL) | 2A |
| HCC patients who had previously been treated with sorafenib | 2B |
| First-line therapy for adult and pediatric patients with recurrent or locally advanced or metastatic Merkel cell carcinoma (MCC) | 2A |
| Combination with axitinib (Inlyta) as first-line treatment for patients with metastatic renal cell cancer (RCC) (poor and intermediate risk—Category 1*; favorable risk—Category 2A*) | 1* 2A* |