FDA 'Breakthrough' status for Janssen's JNJ-4528

9 December 2019

The US Food and Drug Administration has granted Breakthrough Therapy designation for JNJ-68284528 (JNJ-4528), an investigational B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy in previously-treated patients with multiple myeloma, from Johnson & Johnson (NYSE: JNJ) subsidiary Janssen.

"The granting of Breakthrough Therapy Designation for JNJ-4528 is a significant milestone as we continue to accelerate the global development of this innovative CAR-T therapy in collaboration with Legend Biotech," said Dr Sen Zhuang, vice president, oncology clinical development, at Janssen Research & Development, adding: "We look forward to continuing to work closely with the US Food and Drug Administration to advance the clinical development program for JNJ-4528 and ultimately bring this BCMA-targeted immunotherapy to patients living with multiple myeloma who are in need of a new therapeutic option."

Clinical backing

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