Regeneron Wins CHMP Backing of Lymphoma Drug Odronextamab
By Colin Kellaher
Regeneron Pharmaceuticals on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of odronextamab for certain patients with the two most-common subtypes of non-Hodgkin lymphoma.
The Tarrytown, N.Y., biotechnology company said the recommendation covers odronextamab for adults with relapsed/refractory follicular lymphoma or diffuse large B-cell lymphoma after two or more lines of systemic therapy.
The European Commission, which generally follows CHMP's advice, will now review the recommendation, with a decision expected in the coming months.
The U.S. Food and Drug Administration in March turned away Regeneron's application seeking approval of odronextamab due to issues related to the enrollment status of confirmatory trials.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
June 28, 2024 07:44 ET (11:44 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.-
Six Sports Betting and iGaming Stocks Trading at a Discount
-
4 Predictions for Stocks and the Economy for the Second Half of 2024
-
What Broadening Rally? AI Stocks Dominate Again In Q2
-
After Earnings, Is Nike Stock a Buy, a Sell, or Fairly Valued?
-
Worst-Performing Stock ETFs of the Quarter
-
Top-Performing Stock ETFs of the Quarter
-
Q2 In Review and Q3 2024 Market Outlook
-
5 Stocks to Buy for 3Q 2024
-
Industrials: Sector Offers Investment Opportunities as Performance Lags Broader Market
-
Consumer Defensives: Even Amid Macro Pressures, Deals Permeate the Landscape
-
33 Undervalued Stocks
-
Utilities: Can the Stocks Keep the Rally Going?
-
Basic Materials: Following Index Decline, We See Many Long-Term Opportunities
-
Healthcare: Valuations Look Attractive In Most Industries
-
Financial Services: Amid Uncertainties, We See the Most Value In Banks and Credit Services
-
Consumer Cyclicals: Even With Anxiety Over Spending, We See Attractive Valuations