Commissioner’s National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for Comments

The commenter advocates for the approval and release of a specific treatment (Anktiva/ImmunityBio Inc.) to treat conditions like lymphopenia and sepsis. They argue that the treatment is safe and effective and should be made available to the thousands of people currently waiting for it.

An individual patient or family member advocates for the approval of Anktiva for the treatment of Glioblastoma. They argue that the disease is rapidly progressive and devastating, emphasizing the urgent need for treatment options for patients with limited hope.

Mohammad Zaman, PhD, argues that ANKTIVA and related ImmunityBio immunotherapy programs should be prioritized under the Commissioner’s National Priority Voucher Pilot Program due to their ability to address significant unmet medical needs in various cancers. He highlights the drug's innovative IL-15 mechanism, its existing FDA approval, and the potential for substantial public health benefits and improved patient outcomes.

A healthcare provider advocates for the approval of ANKTIVA for expanded use and "right to try" status. They argue that providing more treatment options improves patient outcomes, provides hope for families, and offers medical professionals more tools to help their patients.

A private individual is requesting that the government take steps to make the drug Anktiva available to treat lymphopenia caused by cancer treatments. The commenter argues that access to this treatment is necessary to improve the survival odds for patients with compromised immune systems.

Lori Mills, a caregiver and patient advocate, supports the CNPV Pilot Program and urges the FDA to use it to accelerate access to life-saving immunotherapies like ANKTIVA. She shares her husband's successful recovery from terminal brain cancer as evidence of the need for streamlined approvals and expanded access for aggressive diseases.