Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-9753/1
Trade NameDose FormStrengthIdentifier
KeytrudaConcentrate for infusion25 mg/mL(100 mg/4 mL)
SponsorApplication dateRegistration situationClassification
Merck Sharp & Dohme (New Zealand) Limited
P O Box 99851
Newmarket
Auckland 1149
31/3/2016Consent given
Approval date: 29/3/2018
Prescription
 

Composition

ComponentIngredientManufacturer
concentrate for infusionActive 
 Pembrolizumab 25 mg/mLAstraZeneca Pharmaceuticals LP
Frederick Manufacturing Centre FMC
633 Research Court, Frederick
Maryland 21703
United States of America
  Boehringer Ingelheim Pharma GmbH & Co KG
Birkendorfer Strasse 65
Biberach an der Riss 88397
Germany
 Excipient 
 Histidine
 Histidine hydrochloride monohydrate
 Polysorbate 80
 Sucrose
 Water for injection

Production

Manufacturing stepManufacturer
Finished Product TestingCovance Laboratories Limited
Otley Road
Harrogate
North Yorkshire HG3 1PY
United Kingdom
 MSD International GmbH (Ireland)
Dublin Road
Carlow
County Carlow
Ireland
 MSD International GmbH
Brinny
Innishannon
Co. Cork
Ireland
 Nuvisan Gmbh
Wegenerstrasse 13
Neu-Ulm 89231
Germany
 NV Organon
Kloosterstraat 6
Oss 5349 AB
Netherlands
Manufacture of Final Dose FormMSD International GmbH (Ireland)
Dublin Road
Carlow
County Carlow
Ireland
PackingMSD International GmbH (Ireland)
Dublin Road
Carlow
County Carlow
Ireland
Secondary PackagingSchering-Plough Labo NV
Industriepark 30
Heist-op-den-Berg B-2220
Belgium
NZ Site of Product ReleasePharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Mangere
AUCKLAND 2022

Packaging

PackageContentsShelf Life
Vial, glass, Type I , 4 mL fill, closed with a chlorobutyl stopper, polypropylene cap and aluminium flip-off seal1 dose units24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Do not shake.
24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze)
6 hours diluted stored at or below 25°C

Indications

Melanoma

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

KEYTRUDA® is indicated for the adjuvant treatment of patients with melanoma with lymph node involvement who have undergone complete resection.

Non-small cell lung cancer (NSCLC)

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 tumor 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.

Classical Hodgkin Lymphoma (cHL)

KEYTRUDA is indicated for the treatment of patients with refractory classical Hodgkin Lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy.

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) 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.

Head and Neck Squamous Cell Cancer (HNSCC)

KEYTRUDA® is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. This indication is approved based on overall response rate and duration of response. Improvements in overall survival, progression-free survival or health-related quality of life have not been established.

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. Continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials.

Non-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) tumours that have progressed following prior treatment and when there are no satisfactory alternative treatment options. This indication was approved based on the pooling of data on objective response rate and response duration across multiple different tissue types in a single-arm trial. 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. Continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials.
The safety and effectiveness of KEYTRUDA in paediatric patients with MSI-H central nervous system cancers have not been established.

Renal Cell Carcinoma

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

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
28/4/2020CMN 24(5)Indications/dosage - Grade 1; Indications/dosage - Grade 2; Administrative fee (CMN)Initial evaluation6/5/2020 
12/3/2020Changed Medicine NotificationShelf life/storage conditions - finished product; Administrative fee (CMN)Information requested 20/5/202018/3/2020 
31/3/2016New Higher-risk Medicine ApplicationAdditional dose form - higher-risk medicine - Grade 1 or 2Granted 29/3/201812/4/2016 
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