Revised: 31 May 2019

Medicines

	Medsafe Product Detail
		File ref: TT50-9753/1

Composition

Production

Packaging

Indications

Melanoma

KEYTRUDA® (pembrolizumab) is indicated as monotherapy for the treatment of unresectable or metastatic melanoma in adults.

KEYTRUDA® is indicated for the adjuvant treatment of adult and paediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma who have undergone 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 non-squamous non-small cell lung carcinoma (NSCLC), with no EGFR or ALK genomic tumour aberrations.

KEYTRUDA in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as monotherapy is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumour proportion score (TPS) >/=1%] as determined by a validated test, with no EGFR or ALK genomic tumour aberrations and is
- Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
- metastatic

KEYTRUDA as monotherapy is indicated for the treatment of patients with advanced NSCLC whose tumours express PD-L1 with a >/=1% TPS as determined by a validated test and who have received platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have received prior therapy for these aberrations prior to receiving KEYTRUDA.

KEYTRUDA® as monotherapy is indicated for the adjuvant treatment of patients with Stage IB (T2a greater than or equal to 4 cm), II, or IIIA NSCLC who have undergone complete resection.

Classical Hodgkin Lymphoma (cHL)

KEYTRUDA® is indicated for the treatment of adult and paediatric patients with relapsed or refractory classical Hodgkin Lymphoma (cHL).

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 tumours express PD-L1 [Combined Positive Score (CPS) greater than or equal to 10] as determined by a validated test, 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 received 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 tumours who are ineligible for or have elected not to undergo cystectomy.

Head and Neck Squamous Cell Cancer (HNSCC)

KEYTRUDA, in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as monotherapy, is indicated for the first-line treatment of patients with metastatic or unresectable recurrent HNSCC, whose tumours express PD-L1 [Combined Positive Score (CPS) greater than or equal to 1] as determined by a validated test.

KEYTRUDA, as monotherapy is indicated for the treatment of patients with metastatic or unresectable recurrent HNSCC with disease progression on or after platinum-containing chemotherapy.

Microsatellite instability-high Cancer

Colorectal
KEYTRUDA® is indicated in adult and paediatric patients for the treatment of unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication was approved based on objective response rate and response duration in a single-arm trial.

Non-colorectal
KEYTRUDA® is indicated in adult and paediatric patients for the treatment of unresectable or metastatic, MSI-H or dMMR tumours that have progressed following prior treatment and when there are no satisfactory alternative treatment options. Sample sizes for individual tissue types were too small to provide data on clinical utility of the MSI-H/dMMR tests for each of the tissue types, individually. The assumption that MSI-H/dMMR-status is predictive of the treatment effect of KEYTRUDA for every tissue type has not been verified.

The safety and effectiveness of KEYTRUDA in paediatric patients with MSI-H central nervous system cancers have not been established.

Renal Cell Carcinoma

KEYTRUDA®, as monotherapy, 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

KEYTRUDA®, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC)

KEYTRUDA® (pembrolizumab), in combination with lenvatinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC)

Oesophageal Cancer

KEYTRUDA®, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the oesophagus or gastroesophageal junction.

Colorectal Cancer

KEYTRUDA® is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Endometrial Carcinoma

KEYTRUDA®, in combination with lenvatinib, is indicated for the treatment of patients with advanced endometrial carcinoma, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

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 monotherapy as adjuvant treatment after surgery.

KEYTRUDA® in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumours express PD-L1 (CPS >/= 10) as determined by a validated test.

Cervical Cancer

KEYTRUDA®, in combination with platinum chemotherapy and paclitaxel, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD-L1 [Combined Positive Score (CPS) >/= 1] as determined by a validated test.

Cutaneous squamous cell carcinoma

KEYTRUDA® is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.

Gastric Cancer

KEYTRUDA®, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumours express PD-L1 [Combined Positive Score (CPS) greater than or equal to 1] as determined by a validated test.

Latest Regulatory Activity