The U.S. Food and Drug Administration named Richard Pazdur, its longtime overseer of cancer therapies, as its top drug regulator, according to STAT. This appointment comes on the heels of former Center for Drug Evaluation and Research Director George Tidmarsh’s departure, which was marred by allegations of misuse of regulatory authority and internal conflicts. Pazdur, who has been with the FDA for 26 years and founded the agency’s Oncology Center of Excellence, is expected to bring stability to a division that has faced declining morale and staff turnover. His leadership marks the third change at the helm of CDER since President Trump took office, raising concerns about the consistency of regulatory decisions in the industry, as noted by Raymond James analyst Chris Meekins.
Simultaneously, pharmaceutical companies are embarking on one of the most significant cancer spending sprees in recent years, investing billions into developing combination therapies that merge existing drugs like Merck’s Keytruda and Roche’s Avastin. Despite the lack of substantial evidence that these combinations can significantly extend patient survival, the potential for a new class of treatments has ignited a rush among drugmakers. Over the past year, companies have announced more than $6 billion in deals for these PD-1/VEGF bispecific antibodies, indicating a strong belief in their market potential, even as they prepare to invest heavily in clinical trials involving thousands of patients.
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