Approve ImmunityBio’s BioShield Anktiva by the FDA

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The Issue

We, the undersigned citizens, patients, caregivers, and advocates for cancer research and treatment, urgently petition President Trump to take immediate executive action to expedite the full FDA approval of ImmunityBio's Cancer BioShield platform, anchored by Anktiva (N-803), for the treatment of lymphopenia in patients with solid tumors and advanced cancers. This groundbreaking immunotherapy has shown transformative potential in reversing immune suppression and extending survival, yet bureaucratic delays continue to deny hope to thousands of Americans battling cancer.  The Crisis: Lymphopenia as a Barrier to Cancer Survival lymphopenia—the severe depletion of lymphocytes (white blood cells critical to immune defense)—affects up to 50% of cancer patients undergoing chemotherapy, radiation, or immunotherapy. This condition not only weakens the body's ability to fight tumors but also leads to higher rates of infection, treatment resistance, and mortality. In advanced non-small cell lung cancer (NSCLC), for instance, lymphopenia is a key factor in why checkpoint inhibitors like PD-1 therapies fail in resistant patients. 

 Without effective interventions, lymphopenic patients face a grim prognosis, with survival rates plummeting despite otherwise promising therapies.  America's cancer patients deserve better. Under your leadership, President Trump, we have seen bold moves to cut red tape and prioritize American innovation—such as Operation Warp Speed, which delivered life-saving COVID-19 vaccines in record time. Now, we call on you to apply that same urgency to Cancer BioShield, a "first-in-class" strategy designed to restore immune competence by stimulating natural killer (NK) cells and memory T cells, overcoming tumor escape and reversing lymphopenia. 

The Promise of Cancer BioShield and Anktiva: Evidence of Real ResultsDeveloped by ImmunityBio, Cancer BioShield leverages Anktiva—an IL-15 superagonist—to activate the immune system without the toxicity of traditional chemotherapies. Key evidence from recent clinical data includes:  Reversal of Lymphopenia and Extended Survival: In patients with advanced NSCLC resistant to checkpoint therapy, Anktiva reversed lymphopenia and extended overall survival, offering a lifeline where none existed before. 

100% Disease Control in High-Risk Cases: Early data from trials showed 100% disease control in five out of five patients with refractory solid tumors, by boosting NK cells to target resistant cancer clones. 

FDA Expanded Access Granted: In June 2025, the FDA authorized expanded access for Anktiva under Cancer BioShield to treat lymphopenia in adult patients with relapsed or refractory solid tumors, acknowledging its safety and efficacy in compassionate use. 
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 This is not unproven theory—it's a platform poised to redefine cancer care, much like how your administration championed precision medicine.

Yet, full approval remains stalled. Lymphopenia is an orphan condition with few treatments, leaving patients in limbo. Expanded access helps a few, but widespread approval would empower oncologists nationwide to integrate Cancer BioShield into standard protocols, potentially saving lives and reducing healthcare costs.  Our Call to Action: Make America Cancer-Resistant AgainPresident Trump, your commitment to "Make America Great Again" includes fighting for American lives against invisible enemies like cancer. We urge you to:  Direct the FDA to Prioritize Review: Issue an executive order accelerating the Biologics License Application (BLA) for Anktiva in lymphopenia, invoking emergency use authorities if needed, similar to your successful vaccine rollout.  
Support Funding and Incentives: Allocate resources through the Department of Health and Human Services to expand clinical trials and manufacturing, ensuring rapid deployment.  
Champion Bioshield Innovation: Elevate Cancer BioShield as a national priority, partnering with ImmunityBio to make this "Bioshield" against cancer accessible to all Americans.

This is not just about one drug—it's about unleashing American ingenuity to conquer cancer, restoring faith in our institutions, and giving patients the fighting chance they deserve. We stand ready to mobilize in support of your bold vision for health freedom.  

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