Shares of the New York drugmaker jumped Friday morning after it said Opdivo fared better than the chemotherapy drug docetaxel when tested in a late-stage study involving patients with an advanced form of non-squamous non-small cell lung cancer. The main goal of the study was measuring overall survival rates.
Late-stage research is generally the final phase of clinical testing for a drug before regulators decide whether to approve it.
Bristol-Myers
said an independent data monitoring committee made the decision to stop
the study early. It did not detail the results that prompted that
decision.
The
582 patients in the study had been previously treated and were
receiving intravenous injections of either Opdivo or docetaxel.
Opdivo
is part of a new class of immuno-oncology drugs that harness the immune
system to attack cancer cells. Last month, federal regulators approved
it for patients with the most common form of lung cancer, advanced
squamous non-small cell lung cancer.
In
December, the Food and Drug Administration also granted an accelerated
approval to Opdivo for melanoma, the deadliest form of skin cancer.....Source
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