Micrograph showing a PD-L1 positive non-small cell lung carcinoma. PD-L1 immunostain ,<unk>  is used via intravenous infusion to treat inoperable or metastatic melanoma, metastatic non-small cell lung cancer (NSCLC) in certain situations, as a first-line treatment for metastatic bladder cancer in patients who cannot receive cisplatin-based chemotherapy and have high levels of PD-L1, as a second-line treatment for head and neck squamous cell carcinoma (HNSCC), after platinum-based chemotherapy, for the treatment of adult and pediatric patients with refractory classic Hodgkin's lymphoma (cHL), and recurrent locally advanced or metastatic esophageal squamous cell carcinoma. For NSCLC,<unk>  is a first-line treatment if the cancer overexpresses PD-L1, a PD-1 receptor ligand, and the cancer has no mutations in EGFR or in ALK; if chemotherapy has already been administered, then<unk>  can be used as a second-line treatment, but if the cancer has EGFR or ALK mutations, agents targeting those mutations should be used first. Assessment of PD-L1 expression must be conducted with a validated and approved companion diagnostic.<unk>  (Pembro) use for treatment of Lung cancer in the first line with or without chemotherapy (Chemo). Median overall survival in months (M). Hazarad Ration (HR). KEYNOTE-024, KEYNOTE-042, KEYNOTE-189, and KEYNOTE-407. Adapted from: First line Immunotherapy for Non-Small Cell Lung Cancer Nasser NJ, Gorenberg M, Agbarya A. Pharmaceuticals (Basel). 2020 Nov 8;13(11):373. https://doi.org/10.3390/ph13110373 In 2017, the U.S. Food and Drug Administration (FDA) approved<unk>  for any unresectable or metastatic solid tumor with certain genetic anomalies (mismatch repair deficiency or microsatellite instability). This was the first time the FDA approved a cancer drug based on tumor genetics rather than tissue type or tumor site; therefore,<unk>  is a so-called tissue-agnostic drug. In the European Union,<unk>  is indicated for: * the treatment of advanced (unresectable or metastatic) melanoma in adults as monotherapy. * the adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection as monotherapy. * the first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumors express PD-L1 with a ≥ 50% tumor proportion score (TPS) with no EGFR or ALK positive tumor mutations as monotherapy. * the first-line treatment of metastatic non-squamous NSCLC in adults whose tumors have no EGFR or ALK positive mutations in combination with pemetrexed and platinum chemotherapy. * the first-line treatment of metastatic squamous NSCLC in adults in combination with carboplatin and either paclitaxel or nab-paclitaxel. * the treatment of locally advanced or metastatic NSCLC in adults whose tumors express PD-L1 with a ≥ 1% TPS and who have received at least one prior chemotherapy regimen. People with EGFR or ALK positive tumor mutations should also have received targeted therapy before receiving Keytruda as monotherapy. * the treatment of adults with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV as monotherapy. * the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy as monotherapy. * the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD L1 with a combined positive score (CPS) ≥ 10 as monotherapy. * the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumors express PD-L1 with a CPS ≥ 1 as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy. * the treatment of recurrent or metastatic HNSCC in adults whose tumors express PD-L1 with a ≥ 50% TPS and progressing on or after platinum-containing chemotherapy as monotherapy. * the first-line treatment of advanced renal cell carcinoma (RCC) in adults in combination with axitinib. In June 2020, the U.S. FDA approved a new indication for<unk>  as the first-line treatment for people with unresectable or metastatic microsatellite instability-high (MSI‑H) or mismatch repair deficient (dMMR) colorectal cancer. The approval marks the first immunotherapy approved for that population in the US as a first-line treatment and which is administered to people without also giving chemotherapy. In March 2021, the U.S. FDA approved<unk>  in combination with platinum and fluoropyrimidine-based chemotherapy to treat metastatic or locally advanced esophageal or gastroesophageal (GEJ) (tumors with epicenter 1 to 5 centimeters above the gastroesophageal junction) carcinoma in people who are not candidates for surgical resection or definitive chemoradiation. Efficacy was evaluated in KEYNOTE-590 (NCT03189719), a multicenter, randomized, placebo-controlled trial that enrolled 749 participants with metastatic or locally advanced esophageal or gastroesophageal junction carcinoma who were not candidates for surgical resection or definitive chemoradiation. In May 2021, the U.S. FDA approved<unk>  in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of people with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. Approval was based on the prespecified interim analysis of the first 264 participants of the ongoing KEYNOTE-811 (NCT03615326) trial, a multicenter, randomized, double‑blind, placebo‑controlled trial in people with HER2‑positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who had not previously received systemic therapy for metastatic disease. In July 2021, the U.S. FDA approved<unk>  for high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. The FDA also granted regular approval to<unk>  in combination with chemotherapy for people with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (Combined Positive Score CPS ≥10) as determined by an FDA approved test. In November 2021, the U.S. FDA approved<unk>  for the adjuvant treatment of people twelve years of age and older with stage IIB or IIC melanoma following complete resection. In March 2022, the U.S. FDA approved<unk>  for the treatment of advanced endometrial cancer.
Pembrolizumab
Nivolumab
Afatinib
Ipilimumab
Loncastuximab tesirine
Acalabrutinib
Imatinib
Sorafenib