The company is studying the mRNA tumor-associated antigen vaccine as a monotherapy and in combination with Keytruda.
The firm originally filed a BLA in 2023, but the FDA twice delayed its approval decision on the gene therapy and requested more CMC information.
Severe gastrointestinal inflammation could occur in 2 percent to 3 percent of patients who receive Carvykti, the FDA has informed patients and doctors.
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