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Safety Profile Of Merck’s Anti-PD-1 Keytruda Shines In FDA Labeling

This article was originally published in The Pink Sheet Daily

Executive Summary

Priced at $12,500/month, Keytruda will be ready to ship within one week of FDA approval for relapsed melanoma after failure of Yervoy and a BRAF inhibitor. Approval could spur interest in off-label use of PD-1 inhibitor as a first-line treatment.

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European Notebook: U.K. Early Access Scheme Starts; New HTA Body In Portugal; Doctors Oppose French Health Bill

Merck’s Keytruda is made available before approval under U.K.’s new EAMS project; Portugal sets up a new technology assessment body, while Germany’s IQWIG says HTA dossiers could be a useful source of clinical trial data for other uses; in France, clinical trial lead times are lengthening and doctors protest a proposed reimbursement change.

More Than 2,000 Patients Already Using Merck’s Keytruda

The immunotherapy is getting a strong reception from melanoma patients, but is behind Bristol’s Opdivo in the lung cancer setting.

Late-Stage Data Advantage Or Just Late To The Game: Bristol’s Opdivo Approval Sets Off PD-1 Competition

Nivolumab approval for melanoma pits more mature data set against first-to-market advantage as company sets to compete against the first PD-1 immunotherapy to market, Merck’s Keytruda.

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