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Health care stocks were advancing in early morning trading Friday as the Health Care Select Sector SPDR Fund was up 0.7% and the iShares Biotechnology ETF was adding 0.9% recently.
AbbVie shares rose 8% after the company reported higher Q4 net revenue.
Vertex Pharmaceuticals shares rose 5.7% in recent trading after it said Friday it has made a reimbursement agreement with National Health Service England for eligible sickle cell disease patients to access the CRISPR/Cas9 gene-edited therapy, Casgevy. The company also said late Thursday the US Food and Drug Administration has approved Journavx for the treatment of adults with moderate-to-severe acute pain.
Bristol-Myers Squibb said the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of Opdivo plus Yervoy as a first-line treatment for adult patients with unresectable or advanced hepatocellular carcinoma, a type of liver cancer. The company's shares rose 0.5%.
By Colin Kellaher
Bristol Myers Squibb said a key European regulatory committee is backing expanded approvals for its CAR-T cell therapy Breyanzi and its Opdivo plus Yervoy cancer-drug combination.
Bristol Myers on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Breyanzi for the treatment of adults with relapsed or refractory follicular lymphoma who have received two or more prior lines of systemic therapy.
Breyanzi is already approved in several lymphoma indications in Europe.
The Princeton, N.J., biopharmaceutical company said the CHMP also recommended approval of Opdivo plus Yervoy for the first-line treatment of adults with unresectable or advanced hepatocellular carcinoma, which accounts for up to 85% of all liver cancers.
The Opdivo/Yervoy combination is already approved in several cancer indications in Europe.
The European Commission, which generally follows CHMP's advice, will now review the recommendations, with its decisions expected within about two months.
Write to Colin Kellaher at colin.kellaher@wsj.com
Bristol-Myers Squibb said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of Opdivo plus Yervoy as a first-line treatment for adult patients with unresectable or advanced hepatocellular carcinoma, a type of liver cancer.
The company said the recommendation is based on a phase 3 trial, which showed statistically significant and clinically meaningful improvement in the primary endpoint of overall survival.
The committee opinion will be reviewed by the European Commission, which has the authority to approve medicines in the European Union, the company said.
Bristol-Myers Squibb said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of Breyanzi for the treatment of adult patients with relapsed or refractory follicular lymphoma.
The company said the recommendation was based on data from a phase 2 study, where Breyanzi demonstrated an overall response rate of 97.1% and complete response rate of 94.2%.
The European Commission is set to review the committee's recommendation, with the final decision expected within about two months, Bristol-Myers Squibb said.
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