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Bristol-Myers Squibb receives CHMP recommendation for Opdivo approval
Bristol-Myers Squibb has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended its drug Opdivo for approval as a lung cancer therapy.
The PD-1 immune checkpoint inhibitor has been endorsed for the treatment of locally advanced or metastatic squamous non-small cell lung cancer after prior chemotherapy in adults.
This positive opinion is based on the overall survival benefit the drug demonstrated in CheckMate -017. It is the first therapy of its kind to receive a positive opinion from the CHMP for the treatment of this condition.
It comes after Opdivo was also recommended for the treatment of advanced melanoma by the CHMP last month.
Michael Giordano, senior vice-president and head of development for oncology at Bristol-Myers Squibb, said: "Today's announcement of a positive opinion for nivolumab in NSCLC brings us closer to delivering on our promise of changing the standard of care for lung cancer."
The firm will be presenting new Opdivo research data at the American Society of Clinical Oncology's annual meeting later this week.
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