Pharmaceutical Executive Daily: FDA Approves Darzalex Faspro

Welcome to Pharmaceutical Executive Daily, your quick briefing on the top news shaping the pharmaceutical and life sciences industry.

In today’s Pharmaceutical Executive Daily, we cover the FDA’s approval of Darzalex Faspro for adults with high-risk smoldering multiple myeloma, the industry’s growing interest in direct-to-patient wholesale models, and the FDA’s expansion of its National Priority Voucher program to accelerate review of critical therapies.

The FDA has approved Darzalex Faspro, Janssen’s subcutaneous formulation of daratumumab, for adults with high-risk smoldering multiple myeloma. The decision marks the first approved therapy for this patient population, based on the pivotal Phase III AQUILA trial. Data showed Darzalex Faspro significantly reduced the risk of disease progression or death compared with observation alone. Experts say the approval represents a major advance in early myeloma management and could shift treatment paradigms toward earlier intervention.

At the same time, pharmaceutical manufacturers are exploring direct-to-patient wholesale distribution models, aiming to reshape drug delivery and pricing frameworks. These initiatives allow companies to bypass traditional pharmacy benefit intermediaries, providing patients faster access and potentially lower costs. Industry leaders note that the approach may also enhance data transparency and improve adherence tracking, though it could pose logistical and compliance challenges as companies test new fulfillment and support models.

Finally, the FDA has expanded its National Priority Voucher (CNPV) program, adding six new therapies addressing urgent public health and national security priorities. The latest group includes products for obesity, cancer, sickle cell disease, and drug-resistant tuberculosis, bringing the total number of voucher-eligible therapies to 15. The program’s goal is to accelerate review timelines for high-impact treatments, cutting the standard 10- to 12-month review window down to as little as two months.

Thanks for listening to Pharmaceutical Executive Daily. For more updates and in-depth analysis, visit PharmExec.com.