Bristol Myers Squibb, a leading pharmaceutical company, recently announced that their drug, Opdivo, is on its way to earning European approval. The Committee for Medicinal Products for Human Use (CHMP), a division of the European Medicines Agency, has recommended Opdivo for approval. The drug, in combination with cisplatin and gemcitabine, is used for first-line treatment in adult patients who are suffering from unresectable or metastatic urothelial carcinoma.
The positive recommendation from CHMP is based on the outcomes of a sub-study conducted as part of the CheckMate -901 trial. The recommendation will now be reviewed by the European Commission, with a final decision expected in June 2024.
In related news, on March 7th 2024, the US Food and Drug Administration approved the use of Opdivo, combined with cisplatin and gemcitabine, as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma after a Priority Review.
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