publication date: Oct. 16, 2020

Drugs & Targets

Keytruda receives FDA approvals in Hodgkin lymphoma indications

Keytruda (pembrolizumab) has received an expanded label use from FDA as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma.

FDA also approved an updated pediatric indication for Keytruda for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after two or more lines of therapy.

Keytruda is sponsored by Merck.

The approval in adults is based on results from the phase III KEYNOTE-204 trial in which Keytruda significantly reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.48-0.88; p<0.0027]) compared to brentuximab vedotin.

Median progression-free survival was 13.2 months (95% CI, 10.9-19.4) for patients treated with Keytruda and 8.3 months (95% CI, 5.7-8.8) for patients treated with BV.

Keytruda was previously approved under the FDA’s accelerated approval process for the treatment of adult and pediatric patients with refractory cHL, or who have relapsed after three or more prior lines of therapy based on data from the KEYNOTE-087 trial.

In accordance with accelerated approval regulations, continued approval was contingent upon verification and description of clinical benefit; these accelerated approval requirements have been fulfilled with the data from KEYNOTE-204.

This approval was reviewed under the FDA’s Project Orbis.

 

United Kingdom signs on to FDA’s Project Orbis

The United Kingdom plans to join two international initiatives that will allow pharmaceutical companies to submit medicines to be reviewed by several countries at the same time, pooling resources and allowing patients to benefit from earlier access.

The two schemes are:

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