Bristol Myers: EU Panel Backs Opdivo/Yervoy Combo in Malignant Pleural Mesothelioma
April 23 2021 - 7:37AM
Dow Jones News
By Colin Kellaher
Bristol Myers Squibb Co. on Friday said the European Medicines
Agency's Committee for Medicinal Products for Human Use recommended
approval of the combination of its Opdivo and Yervoy cancer drugs
for the first-line treatment of adults with unresectable malignant
pleural mesothelioma.
The New York biopharmaceutical company said the recommendation
is based on positive results from a Phase 3 study in which the
combination showed significantly superior overall survival compared
with standard-of-care chemotherapy.
The European Commission, which generally follows CHMP's advice,
will now review the recommendation.
Bristol Myers said the combination, if approved, would be the
first new treatment option in Europe in 15 years that has shown
improved survival in malignant pleural mesothelioma, a cancer of
the lining of the lungs that is frequently caused by inhaling
asbestos fibers.
Opdivo plus Yervoy-based combinations are already approved in
the EU for indications in non-small cell lung cancer, melanoma and
renal cell carcinoma.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
April 23, 2021 07:22 ET (11:22 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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