2023-05-25 14:07:05 ET
- Legend Biotech ( NASDAQ: LEGN ) said Johnson & Johnson's ( NYSE: JNJ ) unit Janssen-Cilag International filed an application to the European Medicines Agency (EMA) seeking expanded approval of blood cancer drug Carvykti.
- The Type II variation application to the EMA was backed by data from a study called CARTITUDE-4 study, which evaluated Carvykti(ciltacabtagene autoleucel; cilta-cel) to treat adult patients with relapsed and lenalidomide-refractory multiple myeloma who have received one to three prior lines of therapy.
- Carvykti is already approved in the U.S., the EU and Japan to treat certain patients with multiple myeloma — a cancer that forms in a type of white blood cell known as plasma cell.
- Legend said that data from CARTITUDE-4 will be presented in an oral presentation at the American Society of Clinical Oncology (ASCO) Annual meeting on June 5.
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More on Legend and J&J
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- AbbVie Or Johnson & Johnson? Let's Ask Peter Lynch
For further details see:
J&J files for expanded approval of blood cancer drug Carvykti in EU