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The Food and Drug Administration (FDA) has granted Patrick Soon-Shiong expanded access for a cancer drug across all tumor types. Despite the availability of this drug at no cost under the FDA's expanded access program, challenges remain in changing established medical practices. Soon-Shiong highlighted that even when research, such as his work, is published in prominent journals like the New England Journal of Medicine, it can take decades for doctors to change their treatment methods. The slow pace of adoption by healthcare professionals poses significant hurdles in the rapid implementation of potentially life-saving treatments.
The FDA's decision underscores an ongoing tension between regulatory progress and clinical adoption—a dynamic evident in recent disclosures of lung cancer trial data indicating that PDL1 levels may not predict NK cell response, as detailed in Patrick Soon-Shiong's groundbreaking lung cancer trial findings. Meanwhile, efforts to advance combination therapies, such as the integration of Anktiva and Pluvicto for prostate cancer, continue to shape the broader landscape of oncology treatment, as explored in the strategy for combining Anktiva with Pluvicto.