Pharmaceutical Executive Daily: FDA Approves Breyanzi

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, the FDA greenlights an expanded use of Breyanzi, Eli Lilly reports Jaypirca met its primary endpoint in a head-to-head Phase III trial against Imbruvica for CLL/SLL, and new analyses highlight how health systems are strengthening partnerships to support cell and gene therapy commercialization.

The FDA has approved an expanded indication for Breyanzi, broadening access to the CAR T-cell therapy for additional lymphoma populations. The decision builds on previous authorizations and reflects the growinga role of CAR T-cell approaches in hematologic cancer treatment.

Eli Lilly announced that Jaypirca successfully achieved the primary endpoint in a Phase III study comparing it with Imbruvica for chronic lymphocytic leukemia and small lymphocytic lymphoma. According to Lilly, the results demonstrate superior efficacy potential and may position Jaypirca as a competitive option in the CLL/SLL landscape pending regulatory submission.

A new industry analysis underscores how health systems are forming deeper partnerships to advance cell and gene therapy commercialization. These collaborations aim to streamline infrastructure, improve patient access pathways, and prepare for the increasing volume of CGT therapies moving toward approval.

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