Johnson & Johnson's (JNJ) Janssen Biotech unit received the US Food and Drug Administration's approval for the Tec-Dara drug combination to treat adults with multiple myeloma who have received at least one prior therapy, the health regulator said Thursday.
A late-stage clinical trial showed the combination reduced the risk of the condition worsening or fatality by 83% compared with the usual treatments, the FDA said.
The FDA added that this supporting clinical data also transitioned the standalone Tecvayli medication from an accelerated clearance to a conventional approval.
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