July 10 Bristol-Myers Squibb Co said on
Thursday it plans to seek U.S. marketing approval in the third
quarter for its experimental cancer immunotherapy Opdivo as a
treatment for advanced melanoma, which would be months sooner
than Wall Street expected.
The company said it would seek approval to market the drug
to patients who had previously been treated with Bristol-Myers'
already approved melanoma drug Yervoy, which works through a
different mechanism than Opdivo.
Mark Schoenebaum, an analyst with ISI Group, said many
analysts had not expected Bristol-Myers to submit the marketing
application until mid-2015, although he and some others had
speculated an earlier filing was possible.
The U.S. drugmaker in April, in a so-called rolling
submission that will be completed by the year end, asked the
U.S. Food and Drug Administration to approve Opdivo (nivolumab)
to treat patients with another type of cancer, squamous cell
Opdivo works by blocking a protein called PD-1, thereby
enabling the immune system to recognize cancer cells and then
attack them. It is considered one of Bristol-Myers' most
important experimental drugs, with potential to generate
multibillion-dollar annual sales, if approved.
Bristol-Myers shares were little changed in premarket
(Reporting by Ransdell Pierson; Editing by Meredith Mazzilli)