If you missed the FDA hearing about the Commissioner’s National Priority Voucher Program where @LoriMills4CA42 I gave comments, here is what I said:
Good afternoon, distinguished panelists and members of the FDA. As Henry Ford said: “We need a faster horse.”
My name is Karol Hansen. I am a Stage IV breast cancer patient with Mets to the bones. I have been fighting cancer for 10 years. In that time, I have undergone chemotherapy twice, radiation three times, and more than 25 surgeries. The cancer has recurred over 11 times.
10 years ago, Nuelasta was prescribed to me before I even had neutropenia because it’s medically known that chemotherapy causes Netropenia. Neutrophils are an inherent part of the body’s immune system that provide rapid, broad, innate protection against infection and injury. Lymphocytes form the core of the adaptive immune system and are responsible for precise, targeted and long-lasting immunity.
Neulasta, and its biosimilars, is given prophylactically to protect neutrophils. ANK TIVA, manufactured by Immunity Bio in California protects lymphocytes, but it is NOT YET approved by the FDA for all cancer types.
During these years of relentless treatment my Absolute Lymphocyte Count remains critically low — below the threshold associated with increased infections, weakness, treatment failure, and shortened survival. There are millions of cancer patients whose ALC looks just like mine. RIGHT NOW, at the Chan Soon-Shiong Institute for Medicine there are 15,000 patients waiting in line to receive ANK TIVA.
ANK TIVA is the first therapy designed to restore and activate lymphocytes through its IL-15 mechanism. It is the missing piece of immune boosting protection — ANK TIVA is the equivalent to lymphocytes as Neulasta is to neutrophils.
I have intractable, treatment-resistant cancer that has failed standard therapies. If ANK TIVA had been available as standard supportive care a decade ago, I might have been spared years of immune collapse, repeated recurrences, and the physical and emotional toll of more than 25 surgeries. Now I am out of time, out of strength and out of options. The 15,000 patients waiting for ANK TIVA can only get it if an opening is available in a narrow group of clinical trials or through the Extended Access Program, which the clinic has to process one at a time, on a case by case basis. A VERY SLOW process. It took almost a year for me to get approved. That’s not POLITICS, that’s imminent death for critically ill patients.
Ladies and gentlemen, we HAVE the cart, which is ANK TIVA. But, as Henry Ford said, “WE NEED A FASTER HORSE!” The Commissioner’s National Priority Voucher Program IS THAT FASTER HORSE!
Immunity Bio is delivering groundbreaking immune-restoring therapy of ANK TIVA but the FDA needs to approve it as a first line of defense for patients with lymphopenia.
The CNPV Program was created to accelerate exactly these kinds of innovative therapies that address critical unmet needs and can transform patient outcomes. I urge the FDA to prioritize ANK TIVA for full approval and label expansion so that every cancer patient undergoing chemotherapy or radiation can receive lymphocyte support proactively — not as a desperate final measure after years of fighting for survival.
It is TIME for a faster horse at the FDA. Streamline the review process. Provide a patient conduit directly to CNPV. Give us a voice. Speed up access to ANK TIVA. Give future patients the CHANCE at a fuller life that I, and others who have died while waiting, have been denied.
Thank you for listening to my story and for the work you do every day on behalf of patients like me
@EricLDaugh listen up, 501c3's are the biggest tax scam in the business. Want to rip the IRS, open one.
Every one, should be investigated. Not just the Ngo's. which should be banned and revoked immediately. They should ALL have to re-apply.
@TulsiGabbard great to hear... for a potentially more durable outcome please do look into immunitybio and Anktiva. Has been producing amazing results so far... @ImmunityBio@DrPatrick $ibrx @Anktiva @LoriMills4CA42
On June 8, 2026, I’ll speak on the floor of the House to honor and memorialize the brave crew of the 🇺🇸 USS Liberty who died and were wounded in an unprovoked attack by 🇮🇱 Israel on June 8, 1967. Catch my speech on @cspan.
@nicksortor never going to jail if agreed to this,.. potis is throwing No one in jail, ever!
he fears his kids next when he is gone. so that deal baked in