Pat Soon-Shiong, Chairman of Chan Soon-Shiong Family Foundation, Executive Chairman at ImmunityBio, and Executive Chairman of the Los Angeles Times, shared a post on X:
“I have received so many enquiries as to how did the Saudi FDA work with us to grant approval of Anktiva for lung cancer and bladder cancer.
We submitted over 1.6 million pages of data.
The SFDA thoroughly reviewed these and on the basis of the clinical results made the decision to provide accelerated approval for Anktiva in lung cancer, the first in the world.
Explaining how the SFDA went about their review and their approval is best described in their own words below:
‘Positive Results Demonstrated in Clinical Studies The approval of Anktiva is based on a comprehensive evaluation of all available evidence—including efficacy, safety, and quality—in accordance with regulatory requirements.
For NSCLC, results from a single-arm clinical trial in patients who had previously not responded to one or more therapies, including immune checkpoint inhibitors, demonstrated a potential improvement in survival. Based on these findings, the SFDA granted conditional approval for this indication.
A confirmatory trial to demonstrate long-term clinical benefit is required to maintain this approval status. For NMIBC, clinical trial results sowed a complete response rate of 62%. The approval for this indication was based on the complete response rate as the primary endpoint.
Collectively, these results led the SFDA to consider Anktiva as a new treatment option for patients with limited therapeutic alternatives, contributing to improved disease and survival outcomes.
Sustained Efforts to Achieve National Objectives.
This approval reflects the SFDA’s continued commitment to innovation and expanding access to advanced treatment options, thereby enhancing the quality of healthcare in alignment with the goals of the Health Sector Transformation Program, one of the key initiatives of Saudi Vision 2030.’”
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