President Biden Emphasizes Plan for Cancer Moonshot Program
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In his State of the Union Address last week (March 1, 2022) President Joe Biden reiterated his Administration’s commitment to the Cancer Moonshot program, which has an overall goal to accelerate progress against cancer, including to reduce the death rate from cancer by at least 50% over the next 25 years.

The Cancer Moonshot program was launched in 2016 by President Barack Obama with then Vice President Biden overseeing the program. At its launch, Cancer Moonshot set three goals: (1) to accelerate scientific discovery in cancer; (2) foster collaboration; and (3) improve the sharing of data. In December 2016, Congress passed the 21st Century Cures Act, authorizing $1.8 billion in funding for the Cancer Moonshot over seven years with Congressional authorization required annually.

Last month (February 2022), President Biden announced a reignition of the Cancer Moonshot program by highlighting new goals: to reduce the death rate from cancer by at least 50% over the next 25 years and improve the experience of those living with and surviving cancer.

As part of plan to meet the goal of advancing research in cancer and other diseases, President Biden also reiterated in his State of the Union Address his proposal to Congress to fund the formation of a new entity within the National Institutes of Health, the Advanced Research Projects Agency for Health (ARPA-H). If created, ARPA-H would be charged with directing bio/pharmaceutical innovation in areas such as cancer, diabetes, Alzheimer’s disease, and other areas in need of health breakthroughs. It would be modeled after the US Department of Defense’s Defense Advanced Research Projects Agency, which is responsible for progressing breakthrough technologies that protect national security.  The Biden Administration first proposed funding of $6.5 billion to create ARPA-H in its federal budget proposal made in April 2021.

FDA issues new guidances for cancer drugs
In addition, the US Food and Drug Administration (FDA) has issued three final guidances regarding cancer clinical trials that parallel the goals of President Biden’s effort to renew and build upon the Cancer Moonshot initiative.

The first guidance, Inclusion of Older Adults in Cancer Clinical Trials, provides recommendations to sponsors and institutional review boards for including older adult patients, aged 65 years and older, in the clinical trials of cancer drugs. It recommends enrolling older adults in early-phase studies of cancer clinical trials, if appropriate, to obtain information that better informs later phase studies. It also includes recommendations for trial design, recruitment strategies, information collection, and developing and reporting more discrete age groups to encourage enrollment of this historically excluded population.

The second guidance, Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics, provides advice on designing and conducting trials with multiple expansion cohorts that allow for concurrent accrual of patients into different cohorts to assess safety, pharmacokinetics, and anti-tumor activity of first-in human cancer drugs. Pharmaceutical companies and researchers can use trials with expansion cohort design to assess many different aspects of a drug in a single clinical trial to efficiently expedite the clinical development of the drug.

The third guidance, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics, addresses master protocol design, including information on what sponsors should submit to the FDA as part of these trial design approaches. It also directs how sponsors should interact with the FDA to facilitate efficient review and mitigate risks to patients. These clinical trials can help expedite the clinical development of a drug to treat cancer because they allow more than one investigational drug or biologic, more than one disease type, or more than one patient population, to be evaluated under a single clinical trial structure.

Source: White House (State of the Union Address), White House (Press Briefing), the US Food and Drug Administration, and the National Cancer Institute