Friday, May 22, 2015

BMS's Opdivo® Gets "Thumbs Up" -- In NSCLC, In The EU; Already Has It For Melanoma

Merck reported some good news this morning: Keytruda® has the same provisional "thumbs up" from the EU's regulator now for melanoma, as Opdivo® received in April of 2015.

BMS reports overnight that it now has the much much larger "thumbs up" for lung cancers -- from the same regulator. So, again -- BMS is likely 12 to 16 months ahead of Kenilworth, here. From Yahoo! News UK, a bit:

. . . .BMS today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that nivolumab, a PD-1 immune checkpoint inhibitor, be granted approval for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults. The CHMP positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU). . . .

We will keep you posted. Of course, this is also good news for Merck -- it is just better news for BMS. This race is now officially in high gear. Here is my earlier backgrounder on it all.

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