HNSCC (head and neck squamous cell carcinoma)

• For the first-line treatment of metastatic or unresectable recurrent HNSCC as monotherapy, in adult patients whose tumours have PD-L1 expression (CPS ≥ 1) as determined by a validated test.
• For the first-line treatment of metastatic or unresectable recurrent HNSCC in combination with platinum and FU (fluorouracil) chemotherapy, in adult patients.

TNBC (triple-negative breast cancer)

• In combination with chemotherapy, for the treatment of adult patients with locally recurrent unresectable or metastatic TNBC, who have not received prior chemotherapy for metastatic disease and whose tumours express PD-L1 (CPS ≥ 10) as determined by a validated test. Consult the description of the study for the chemotherapy (paclitaxel, nab-paclitaxel or gemcitabine/carboplatin) and dosing regimens used. Marketing authorization with conditions is based on PFS.
• For the treatment of adult patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery. Consult the description of the study for the chemotherapy regimen (carboplatin and paclitaxel, followed by doxorubicin or epirubicin and cyclophosphamide) used.

NSCLC (non-small cell lung carcinoma)

• For the first-line treatment, as monotherapy, of adult patients with metastatic NSCLC or stage III disease where patients are not candidates for surgical resection or definitive chemoradiation, expressing PD-L1 (TPS ≥ 1%) as determined by a validated test, with no EGFR or ALK genomic tumour aberrations. A positive association was observed between the level of PD-L1 expression and the magnitude of the treatment benefit.
• In combination with pemetrexed and platinum chemotherapy, for the treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC.
• In combination with carboplatin and either paclitaxel or nab-paclitaxel, for the treatment of adult patients with metastatic squamous NSCLC with no prior systemic chemotherapy treatment for metastatic NSCLC.
• As monotherapy, for the treatment of adult patients with metastatic NSCLC whose tumours express PD-L1 (TPS ≥ 1%) as determined by a validated test and who have disease progression on or after platinum-containing chemotherapy; patients with EGFR or ALK genomic tumour aberrations should have received an authorized therapy for these aberrations prior to receiving KEYTRUDA®.
• KEYTRUDA® as monotherapy is indicated for the adjuvant treatment of adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC who have undergone complete resection and platinum-based chemotherapy.

UC (urothelial carcinoma)

• For the treatment of adult patients with locally advanced or metastatic UC as monotherapy who have disease progression during or following platinum-containing chemotherapy or within 12 months of completing neoadjuvant or adjuvant platinum-containing chemotherapy.

Cervical cancer

• In combination with chemotherapy with or without bevacizumab, for the treatment of adult patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD-L1 (CPS ≥ 1) as determined by a validated test.

Melanoma

• For the treatment of adult patients with unresectable or metastatic melanoma who have not received prior treatment with ipilimumab; subjects with BRAF V600 mutant melanoma may have received prior BRAF inhibitor therapy.
• For the treatment of adult patients with unresectable or metastatic melanoma and disease progression following ipilimumab therapy and, if BRAF V600 mutation positive, following a BRAF or MEK inhibitor.
• For the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB or IIC melanoma following complete resection.
• For the adjuvant treatment of adult patients with Stage III melanoma with lymph node involvement who have undergone complete resection.

RCC (renal cell carcinoma)

• In combination with axitinib, for the treatment of adult patients with advanced or metastatic RCC with no prior systemic therapy for metastatic RCC.
• In combination with lenvatinib, for the treatment of adult patients with advanced (not amenable to curative surgery or radiation) or metastatic RCC with no prior systemic therapy for metastatic RCC.
• As monotherapy, for the adjuvant treatment of adult patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

CRC (colorectal cancer)

• As monotherapy, for the first-line treatment of adult patients with metastatic MSI-H (microsatellite instability-high cancer) or dMMR (mismatch repair deficient) CRC as determined by a validated test.

Endometrial carcinoma

• In combination with lenvatinib, for the treatment of adult patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior platinum-based systemic therapy, and are not candidates for curative surgery or radiation.

Esophageal Cancer

• In combination with platinum and fluoropyrimidine based chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic carcinoma of the esophagus.

Gastric Cancer or Gastroesophageal junction (GEJ) Adenocarcinoma

• In combination with trastuzumab, fluoropyrimidine- and platinum- containing chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours express PD-L1 (CPS ≥ 1) as determined by a validated test.
• in combination with fluoropyrimidine- and platinum-containing chemotherapy,for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.

MSI-H (microsatellite instability-high cancer)

• As monotherapy, for the treatment of adult patients with unresectable or metastatic MSI-H or dMMR (as determined by a validated test) for:

Biliary Tract Cancer

• For the treatment of adult patients with locally advanced unresectable or metastatic biliary tract carcinoma (BTC), in combination with gemcitabine-based chemotherapy