Merck & Co. on Friday said Keytruda (pembrolizumab) has received accelerated approval from the FDA for the treatment of hepatocellular carcinoma (HCC) in patients who previously received Bayer's Nexavar (sorafenib). The drugmaker explained that the accelerated approval was based on data for the tumour response rate and duration of response. The FDA granted priority review to Merck's filing seeking approval of Keytruda for this indication in July.
According to the drugmaker, the approval was supported by data from the KEYNOTE-224 study of 104 patients with HCC whose disease progressed during or after treatment with Nexavar or were intolerant to sorafenib. Results from the single-arm study revealed that Keytruda was associated with an overall response rate of 17 percent, while among the responding patients, 89 percent and 56 percent had duration of response of at least six months and 12 months, respectively.
Merck Research Laboratories vice president of clinical research Scot Ebbinghaus remarked "the approval of KEYTRUDA for advanced [HCC] marks the second FDA approval for [HCC] in Merck's oncology portfolio this year." Lenvima, which is partnered with Eisai, was authorised by the FDA in August for the first-line treatment of patients with unresectable HCC.
Keytruda was initially awarded accelerated approval by the FDA in 2014 for the treatment of advanced or unresectable melanoma, marking the first clearance of a PD-1 inhibitor in the US. The therapy has since been approved for a number of other indications, most recently gaining clearance for use in combination with chemotherapy for the first-line treatment of patients with metastatic squamous non-small-cell lung cancer (for related analysis, see ViewPoints: Merck & Co.'s Keytruda tightens its grip on lung cancer market).
Merck reported last month that third-quarter sales of Keytruda surged 80 percent year-over-year to about $1.9 billion.
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