Luhan Pharmachem Co., Ltd.

Novartis CAR-T cell therapy CTL019 unanimously (10-0) recommended for approval by FDA advisory committee to treat pediatric, young adult r/r B-cell ALL

Recommendation based on review of CTL019 r / r B-cell ALL development program, including the pivotal Phase II global ELIANA trial

-A Biologics License Application (BLA) for this indication is under FDA priority review; if approved, CTL019 could become first CAR-T cell therapy available

-Positive ODAC recommendation is latest milestone for CTL019 program that started through collaboration with the University of Pennsylvania