Biotech Values

[DewDiligence]

FDA approves Keytruda in first-line NSCLC:

http://finance.yahoo.com/news/fda-approves-merck-keytruda-pembrolizumab-220400949.html

Merck…today announced that the U.S. Food and Drug Administration has approved KEYTRUDA (pembrolizumab)…for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations [i.e. patients with relevant EGFR or ALK mutations get “targeted” therapy rather than immunotherapy in the first–line setting].

…In metastatic NSCLC, KEYTRUDA is approved for use at a fixed dose of 200 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

I expect that a fair proportion of patients who have not progressed in 24 months will continue to take Keytruda, if reimbursement is not an issue.

This FDA approval, which was not in doubt, comes two months before the 12/24/16 PDUFA date. The timing is perfect insofar as MRK reports 3Q16 results tomorrow.