Keytruda Indications/Uses

Melanoma: KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.
KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection.
Non-Small Cell Lung Cancer: KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by a validated test [see Dosage & Administration], with no EGFR or ALK genomic tumor aberrations, and is: stage III where patients are not candidates for surgical resection or definitive chemoradiation; or metastatic.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by a validated test [see Dosage & Administration], with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on approved therapy for these aberrations prior to receiving KEYTRUDA.
KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.
Urothelial Carcinoma: KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [Combined Positive Score (CPS) ≥10] as determined by a validated test [see Dosage & Administration], or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
Classical Hodgkin Lymphoma: KEYTRUDA as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option.
Microsatellite Instability-High or Mismatch Repair Deficient Cancer: KEYTRUDA is indicated for the treatment of adult patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR): solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options; or colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
This indication is approved in the United States (U.S.) under accelerated approval based on tumor response rate and durability of response [see Pharmacology: Clinical Studies under Actions]. Continued approval for this indication in the U.S. may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Renal Cell Carcinoma: KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC.
KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions [see Pharmacology: Clinical Studies under Actions].
Endometrial Carcinoma: KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) as determined by a validated test or not MSI-H, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation [see Dosage & Administration].
Head and Neck Squamous Cell Cancer: KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 (CPS ≥1) as determined by a validated test [see Dosage & Administration].
Esophageal Cancer: KEYTRUDA, in combination with platinum- and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of patients with locally advanced or metastatic carcinoma of the esophagus or HER2 negative gastroesophageal junction adenocarcinoma (tumour centre 1 to 5 centimetres above the gastroesophageal junction) that is not amenable to surgical resection or definitive chemoradiation.
KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10) as determined by a validated test [see Dosage & Administration], with disease progression after one prior line of systemic therapy.
Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer: KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).
Tumor Mutational Burden-High Cancer: KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by a validated test [see Dosage & Administration], that have progressed following prior treatment and who have no satisfactory alternative treatment options.
This indication is approved in the United States (U.S.) under accelerated approval based on tumor response rate and durability of response [see Pharmacology: Clinical Studies under Actions]. Continued approval for this indication in the U.S. may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Limitations of Use: The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.
Triple-Negative Breast Cancer: KEYTRUDA is indicated for the treatment of patients with 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.
KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic TNBC in adults whose tumors express PD-L1 with a CPS ≥10 and who have not received prior chemotherapy for metastatic disease [see Dosage & Administration].
Cervical Cancer: KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by a validated test [see Dosage & Administration].
Biliary Tract Cancer: KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).
Gastric Cancer: KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by a validated test [see Dosage & Administration].
This indication is approved in the United States (U.S.) under accelerated approval based on tumor response rate and durability of response [see Pharmacology: Clinical Studies under Actions]. Continued approval of this indication in the U.S. may be contingent upon verification and description of clinical benefit in the confirmatory trials.
KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Adult Indications: Additional Dosing Regimen of 400 mg Every 6 Weeks: KEYTRUDA is indicated for use at an additional recommended dosage of 400 mg every 6 weeks for all approved adult indications [see all indications as previously mentioned and Dosage & Administration]. This indication is approved in the United States (U.S.) under accelerated approval based on pharmacokinetic data, the relationship of exposure to efficacy, and the relationship of exposure to safety [see Pharmacology: Pharmacodynamics and Clinical Studies under Actions]. Continued approval for this dosing in the U.S. may be contingent upon verification and description of clinical benefit in the confirmatory trials.