Merck’s Keytruda Receives a New Approval



Keytruda approved for a new indication

In June, the FDA approved Merck & Company’s (MRK) Keytruda for the treatment of individuals with refractory primary mediastinal large B-cell lymphoma (or PMBCL). Keytruda has been approved for both pediatric and adult patients whose PMBCL relapsed following two or more previous lines of therapy.

The approval of Keytruda for the treatment of PMBCL was under the FDA’s accelerated approval regulations, which are based on tumor response rate and durability of response. Post-confirmatory trials, the FDA may grant further approvals.

KEYNOTE-170 trial

The accelerated FDA approval of Merck’s Keytruda for the treatment of PMBCL was based on the results from the KEYNOTE-170 trial.

In the KEYNOTE-170 trial, among those patients receiving Keytruda, 45% achieved an ORR (objective response rate), 11% achieved a complete response, and 34% achieved a partial response.

In the KEYNOTE-170 trial, 53 patients with PMBCL were treated with Keytruda. Among these 53 patients, 8% had to discontinue Keytruda due to adverse reactions, and 15% saw their treatment interrupted by adverse reactions.

Merck’s Keytruda reported revenue of $1.5 billion in the first quarter, which reflected a rise of ~151% YoY (year-over-year) and a rise of ~13% sequentially. The approval of the label expansion of Merck’s Keytruda by the FDA is expected to boost the drug’s revenue growth.

Studies estimate that PMBCL accounts for ~6% of total diffuse large B-cell lymphoma cases and between 2% and 4% of total non-Hodgkin lymphoma cases. According to the National Cancer Institute, 75,000 new cases of non-Hodgkin lymphoma are expected to be diagnosed in the United States in 2018.

Some important drugs for use in the treatment of non-Hodgkin lymphoma include Roche’s (RHHBY) Rituxan, Seattle Genetics’ (SGEN) Adcetris, and Gilead Sciences’ (GILD) Zydelig.

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