Relapsed or refractory classical Hodgkin lymphoma - combination treatment with brentuximab vedotin

Active Ingredient: Nivolumab

Indication for Nivolumab

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 - 65 years old)
Therapeutic intent: Curative procedure

Nivolumab in combination with brentuximab vedotin is indicated for the treatment of children 5 years of age and older, adolescents and adults up to 30 years of age with relapsed or refractory classical Hodgkin lymphoma after one prior line of therapy.

For this indication, competent medicine agencies globally authorize below treatments:

3 mg/kg every 3 weeks

For:

Dosage regimens

In the case that patient age in years is ≥ 5 and patient age in years is ≤ 30 :

Intravenous, 3 milligrams nivolumab per kilogram of body weight, once every 3 weeks.

Detailed description

Recommended doses and infusion times for intravenous administration of nivolumab in combination with brentuximab vedotin for relapsed or refractory cHL:

 Combination therapy*
Nivolumab3 mg/kg every 3 weeks over 30 minutes
For Cycle 1 only, nivolumab should be administered on Day 8 of the cycle. For
Cycles 2-6, nivolumab should be administered 30 minutes after completion of
brentuximab vedotin administration, on the same day.
Brentuximab
Vedotin
1.8 mg/kg up to a maximum of 180 mg, every 3 weeks over 30 minutes
For Cycles 1-6, brentuximab vedotin should be administered on Day 1 of the Cycle.

* Treatment is risk-based, response-adapted.

Patients should have tumour assessment after every 2 cycles and discontinue treatment in case of progressive disease at any point of assessment:

  • low risk of relapse: up to 6 cycles of the combination and proceed to consolidation therapy, if achieving complete response
  • standard risk of relapse: up to 4 cycles of the combination and proceed to consolidation therapy, if achieving complete response.

In case of sub-optimal response to 4 cycles of the combination treatment, patients should receive intensification therapy prior to proceeding to consolidation therapy once complete response is achieved.

Duration of treatment

Treatment with nivolumab should be continued as long as clinical benefit is observed or until treatment is no longer tolerated by the patient (and up to maximum duration of therapy if specified for an indication).

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.

Dose escalation or reduction is not recommended for nivolumab in combination with other therapeutic agents. Dosing delay or discontinuation may be required based on individual safety and tolerability.

Nivolumab in combination with other therapeutic agents should be permanently discontinued for:

  • Grade 4 or recurrent Grade 3 adverse reactions;
  • Persistent Grade 2 or 3 adverse reactions despite management.

Active ingredient

Nivolumab

Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody (HuMAb), which binds to the programmed death-1 (PD-1) receptor and blocks its interaction with PD-L1 and PD-L2. Nivolumab potentiates T-cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands. In syngeneic mouse models, blocking PD-1 activity resulted in decreased tumour growth.

Read more about Nivolumab

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