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KEYTRUDA (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
KEYTRUDA
Date registered
Evaluation commenced
Decision date
Approval time
253 (255 working days)
Active ingredients
pembrolizumab
Registration type
EOI
Indication
Classical Hodgkin Lymphoma (cHL)
KEYTRUDA (concentrated powder for injection) is now also indicated as monotherapy for the treatment of adult and paediatric patients with relapsed or refractory classical Hodgkin Lymphoma (cHL):
- following autologous stem cell transplant (ASCT) or
- following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.
The approval of this indication in paediatric patients is on the basis of objective response rate from patients aged 11 years and older from single arm trial data and extrapolation from adult data (see Section 5.1 Pharmacodynamic Properties, Clinical Trials).