Monday, July 7, 2014

Filed Under "Told Ya' So" Dept.: Nivolumab IS First Approved -- WORLDWIDE

But first -- the caveats -- it is Japan, not the EU or the US. Japan's market for unresectable melanoma is much smaller than the US or EU. But BMS's nivolumab (now branded as Opdivo® in Japan, at least) broke quite nicely, here -- from the gate. The global horse race is underway, proper.

And it is worth something to be. . . first. With the US FDA accepting a rolling submission on nivolumab -- back in April -- it is likely that the BMS jacket at FDA is nearly complete, in DC. Approval could come in October, maybe even slightly ahead of Merck -- as Merck has an indicated decision date of October 28, here. Per PharmaTimes, then -- do go read it all:

. . . .[BMS is] the first company in the world to get an approval for a PD-1 checkpoint inhibitor, as regulators in Japan gave the green light to nivolumab, developed with Bristol-Myers Squibb, as a treatment for melanoma.

The drug will be marketed as Opdivo for unresectable melanoma. . . .

Just a couple of weeks ago, B-MS stopped its Phase III study assessing nivolumab in melanoma after independent regulators found that it showed a superior survival benefit over dacarbazine. It is being studied in multiple tumour types in 35 different trials, notably for non-small cell lung cancer. . . .

So it goes -- Whitehouse Station must have been expecting this -- but it will be in high gear, now on pembrolizumab, at US FDA from now until its Advisory Committee meeting gets calendared. A huge leap forward in treating many cancers, dawns. . . right here, right now. Heady stuff. Onward!

[Just randomly -- this cracked me up: "First Year medical students think they've got every disease under the sun," writes Katy Waldman in Slate. "Practicing physicians think they are indestructible."]

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