KEYTRUDA® 25mg/mL concentrate for solution for infusion as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV

Subtype:

Hodgkin Lymphoma (HL)

License:

EMA

Class:

PD-1 inhibitor

R/R

SmPC: https://www.medicines.org.uk/emc/medicine/33162

1. Approved Labelling

KEYTRUDA® 25mg/mL concentrate for solution for infusion as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV.

2. Treatment Regimen

Treatment must be initiated and supervised by specialist physicians experienced in the treatment of cancer.

KEYTRUDA® should be administered as an intravenous infusion over 30 minutes every 3 weeks. The recommended dose of KEYTRUDA® is 200mg for cHL.

Patients should be treated with KEYTRUDA® until disease progression or unacceptable toxicity. Atypical responses (i.e., an initial transient increase in tumour size or small new lesions within the first few months followed by tumour shrinkage) have been observed. It is recommended to continue treatment for clinically stable patients with initial evidence of disease progression until disease progression is confirmed.

3. AEs/Warnings

Please see section 4.4 of the SmPC.

 

 

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