That said, Lambrolizumab is more likely to first reach market in the United States as a skin cancer drug -- as I say, for melanoma treatment -- then later be prescribed "off-label" directly by oncologists, if/when the newly-announced Phase II study shows good efficacy without increased toxicity -- in advanced carcinomas. [To be clear, Merck/GSK cannot market it off-label directly, under applicable US FDA regulations, but clinicians can always use it, investigationally, if they are willing to eat the potential malpractice risk. A good study outcome here will largely blunt that risk, for the US oncologists. That's how actual, practical pharma/medical practice works.]
And once again, this is smart and aggressive preparation, clearly underway at Whitehouse Station -- to allow MK-3475 the widest possible berth it can reasonably garner, when it does reach US markets, some time next year.
Per the Rock Hill Herald Online, then -- a bit -- do go read it all:
. . . .“Collaborations like this are central to Merck’s strategy to evaluate the potential of MK-3475 for the treatment of cancer,” said Iain Dukes, senior vice president, Licensing and External Scientific Affairs, Merck Research Laboratories. “We look forward to initiating further collaborations to investigate MK-3475 in combination with other anti-cancer agents across a range of tumor types.”
Merck and GlaxoSmithKline entered a collaboration to study MK-3475 with Vortrient® (pazopanib) and other agents in the GlaxoSmithKline portfolio in the future. This Phase I/II clinical trial is designed to evaluate the safety and efficacy of a combination of MK-3475 and pazopanib in treatment naïve patients with advanced renal cell carcinoma. Further details of the collaboration were not disclosed. . . .
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