Merck's Keytruda gives BMS' Opdivo some company with small cell lung cancer nod

fiercepharma | June 18, 2019

Bristol-Myers Squibb's FDA approval for Opdivo in patients with previously treated small cell lung cancer (SCLC) already has looked shaky since the drug failed to extend patients' lives in a phase 3 trial. Now, Opdivo will have to make some room for its archrival, Merck & Co.’s Keytruda, in the same indication. The FDA has approved Keytruda as a monotherapy for SCLC patients who have failed platinum-based chemo and at least one other line of therapy, Merck said Tuesday. Same as Opdivo’s third-line nod doled out last August, the new Keytruda go-ahead was granted under the accelerated approval program based on tumor response rate and duration of response data. In pooled data from the Keynote-158 and Keynote-028 non-randomized trials, which enlisted 83 metastatic SCLC patients who had failed two or more lines of treatment, Keytruda provoked a response in 19% of participants. Among the 16 who responded, 63% of their tumors continued to respond to Keytruda for a year or longer, according to Merck. “Small cell lung cancer, which accounts for 10% to 15% of all lung cancers, is often diagnosed at an advanced stage where the prognosis is very poor and there have historically been limited treatment options,” Patrick Ott of the Dana-Farber Cancer Institute said in a statement.

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Oligonucleotides are short strands of synthetic DNA or RNA that can selectively alter gene expression and protein production.


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