Johnson & Johnson’s Experience Navigating The Commissioner’s National Priority Voucher Program

In an interview with Pharmaceutical Executive, Imran Khan, Md, PhD, Vice President of U.S. medical affairs for hematology, oncologist, Johnson & Johnson, discusseda new combination regimen for relapsed/refractory multiple myeloma, Tecvayli plus Darzalex Faspro.

Dr. Khan also discusses the FDA Commissioner’s National Priority Voucher pilot program, through which this became the first J&J regimen and first blood cancer therapy to be approved via that pathway, only 55 days after filing. He frames this as a recognition of the data’s strength and of J&J’s commitment to moving quickly yet carefully for patients.

He also highlights the scientific rationale: combining Darzalex, a CD38-targeting monoclonal antibody, with Tecvayli, a BCMA-targeting bispecific that recruits T cells to kill myeloma cells.

Both are highly active individually, but together they achieve synergistic efficacy without relying on traditional classes such as IMiDs and proteasome inhibitors.

Dr. Khan also emphasizes safety, noting that Johnson & Johnson implemented IVIG prophylaxis and aligned dosing schedules for both agents in an effort to reduce serious infections for patients.