European drug regulator clears J&J, Legend’s CAR-T therapy

(Reuters) – The European Medicines Agency on Friday recommended the use of Johnson & Johnson (JNJ.N) and its partner Legend Biotech Corp’s (LEGN.O) CAR-T therapy to treat multiple myeloma, nearly a month after the treatment was cleared in the United States.

The drug, Carvykti, was initially tested in China and later in the United States and Japan.

Drugs that have only been tested in China have faced increased scrutiny by the U.S. Food and Drug Administration.

In such a case, the agency on Thursday declined to approve Eli Lilly (LLY.N) and partner Innovent Biologics Inc’s (1801.HK) lung cancer drug, citing a lack of diversity in trials. read more

However, the decisions on Carvykti by the FDA and EMA show that the regulators are open to approving treatments that are also tested elsewhere and not just in China.

The drug now needs approval of the European Commission, which has the final word on market access.

Carvykti belongs to a class of drugs known as CAR-T therapies, or chimeric antigen receptor T-cell therapies. The therapy involves extracting disease-fighting T-cells from a patient, re-engineering them to attack cancer and infusing them back into the body.

Legend and J&J plan to sell the drug in Greater China at 70-30 split in profit and a 50-50 split in all other countries.

Reporting by Manas Mishra in Bengaluru; Editing by Arun Koyyur

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