sBLA submitted to FDA Seeking Approval of CARVYKTI® for the Earlier Treatment of Patients with R/R Multiple Myeloma
“We are focused on advancing CARVYKTI® in the treatment of multiple myeloma, including for patients with relapsed or refractory disease, where we hope to intervene earlier with the goal of transforming outcomes for patients,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “We look forward to collaborating with the FDA on the review of this application and continuing to bring CARVYKTI® to patients who are candidates for this CAR-T therapy.”
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“The interim PFS analysis results demonstrated that, compared to the current standard treatment, KN026 in combination with chemotherapy significantly improved PFS, reduced the risk of disease progression or death, and showed a trend toward OS benefit. Detailed data from this study will be presented at an upcoming international academic conference.”
