KEYTRUDA is indicated in adult and pediatric patients with refractory cHL, or who have relapsed after 3 or more prior lines of therapy

Subtype:

Hodgkin Lymphoma (HL)

License:

FDA

Class:

PD-1 inhibitor

R/R

PI: http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf 

1. Approved Labelling

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

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. 

2. Treatment Regimen

Adult patients: The recommended dose of KEYTRUDA in adults is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

Pediatric patients: The recommended dose of KEYTRUDA in pediatric patients is 2 mg/kg (up to a maximum of 200 mg), administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

3. AE/Warnings

Please see section 5 of the PI.

 

 

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