The U.S. Food and Drug Administration's staff on Wednesday raised concerns that it was unclear if Johnson & Johnson (JNJ.N) and Bristol Myers Squibb's (BMY.N) cell therapies would benefit blood cancer patients when given as early treatments.
Regulatory approval for the therapies as earlier treatments could expand their use to a larger subset of blood cancer patients who are less sick than those treated with multiple therapies. The therapies - J&J's Carvykti and Bristol's Abecma - belong to class known as CAR-T.
FDA's staffers pointed to a pattern of early deaths in late-stage trials of the therapies, saying that it raised questions over the effectiveness of the treatments in extending the time patients live after receiving them.
Carvykti and Abecma are approved by the FDA to treat patients with multiple myeloma who have received at least four prior lines of treatment.
Source-Reuters
Cell Therapy News/Articles, page-17515
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