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Cancer Policy Monitor: October 8. 2024

Appropriations Update

On September 26, President Biden signed H.R. 9747, the Continuing Appropriations and Extensions Act, 2025, into law, avoiding a potentially consequential government shutdown just weeks away from Election Day. Also known as a continuing resolution (CR), this temporary funding measure will keep the federal government operating at Fiscal Year (FY) 2024 spending levels through December 20.

In the weeks leading up to the passage of the CR, both the House and Senate had been working to finalize FY 2025 spending bills. However, disagreements between Democratic and Republican leaders over how to address spending caps and topline funding levels ultimately grounded negotiations on FY 2025 appropriations to a halt.

As a reminder, and prior to the Senate adjourning for the August recess, the Senate Appropriations Committee approved the Senate Labor-HHS-Ed Appropriations Subcommittee bill, which would provide NIH with a $1.8 billion increase to $48.9 billion in FY2025. This 4% increase for NIH compares to flat funding in the version of the bill proposed in July by the House Labor-HHS-Education Appropriations Subcommittee.

We are indebted to our leaders in the Senate, most specifically Senate Appropriations Committee Chair Patty Murray (D-WA) and Senate Appropriations Committee Ranking Member/Vice Chair Susan Collins (R-ME), as well as Senators Tammy Baldwin (D-WI) and Shelley Moore Capito (R-WV), who serve as the Chair and Ranking Member, respectively, on the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, for their efforts to prioritize a robust funding increase for NIH in FY2025.

With the appropriations deadline extended to December, Congress has tabled decisions on FY 2025 spending until the lame duck period. As a result, the outcome of the General Election on November 5 will factor heavily on congressional appropriators as they weigh the possibility of a new party in charge of the White House and both chambers of Congress.

With the fate of the FY 2025 budget still uncertain, the American Association for Cancer Research (AACR) will continue to advocate for the current proposal that the Senate Appropriations Committee is supporting, as it would provide a robust funding increase for the National Institutes of Health (NIH), the National Cancer Institute (NCI), and other research and health programs.

AACR Releases 2024 Cancer Progress Report

-Blake William Rostine

On September 18, the American Association for Cancer Research (AACR) released the 14th edition of the annual Cancer Progress Report. The report provides a comprehensive summary of recent advances in the fight against cancer; highlights challenges that remain in cancer prevention, detection, and treatment; and concludes with a call to action for policymakers to support the NIH and other federal programs that contribute to the fight against cancer. Additionally, this report had an increased focus on pediatric/adolescent and young adult cancers and the strides the medical research community is making in addressing them.

The report highlighted both the progress made in cancer research, as well as opportunities for the medical research community to continue the fight against cancer. The report discusses the 15 new anticancer therapeutics, the 15 previously approved therapeutics for treating new cancer types, and one new imaging agent approved by the FDA. Additionally, it highlights the efforts to reduce the risks of cancer development, emphasizing public health campaigns and policy initiatives like tobacco cessation.

To continue the progress against cancer, the AACR Cancer Progress Report calls on Congress to robustly support crucial federal research and health programs. The report urges Congress to provide significant appropriations increases to the base budgets of the NIH and the NCI, to allocate additional funds to support anticancer programs at the Centers for Disease Control and Prevention (CDC) and the FDA, and to support the broad goals of the Cancer Moonshot so that the medical research community can continue their life-saving work. For more information, see the full AACR Cancer Progress Report‘s Call to Action.

A congressional briefing to highlight the report was held at the National Press Club. The event featured remarks by AACR CEO Margaret Foti, PhD, MD (hc), and AACR President Pat LoRusso, DO, PhD, FAACR. The panel consisted of notable leaders in biomedical research and patient advocates featured in the report. See more information about the survivors featured in the report and watch the Congressional Briefing.

2024 Rally for Medical Research Hill Day Draws Hundreds of Advocates

-Matt Gontarchick

Medical research advocates from across the country gathered in Washington, D.C., September 18-19 for the 12th annual Rally for Medical Research. The American Association for Cancer Research (AACR), the founding organizer and a lead sponsor of the rally, joined over 350 partner organizations to advocate for robust, sustained, and predictable funding increases for the National Institutes of Health (NIH).

Patient advocates, caregivers, researchers, and health professionals gathered for a reception near Capitol Hill on September 18, featuring remarks from NIH Director Monica Bertagnolli, MD; President of the Federation of American Societies for Experimental Biology, Senior Associate Dean for Biomedical Education, and Professor in the Department of Microbiology, Immunology, and Molecular Genetics in the College of Medicine at the University of Kentucky Beth A. Garvy, PhD; Member of the American Heart Association Board of Directors, Managing Director of Morgan Health Ventures, and Member of the Alice L. Walton Board of Directors Cheryl Pegus, MD, MPH; Chief Operating Officer of the Hydrocephalus Association Amada Garzon, MA; and AACR Chief Policy Officer Jon Retzlaff, MBA, MPA. Reception attendees also heard remarks from Michael Methner, a 10-year-old brain tumor patient who was featured in the 2024 AACR Cancer Progress Report.

On September 19, over 270 advocates representing more than 30 states took part in more than 210 meetings with their members of Congress and staff. Participants advocated for Congress to make medical research a national priority by allocating the highest possible increase to the NIH budget in FY 2025. Advocates also urged lawmakers and their staff to complete work on FY 2025 appropriations bills as quickly as possible to avoid the delays and disruptions caused by continuing resolutions and a potential government shutdown.

Advocates and partner organizations also participated in a National Day of Action on September 19, amplifying the rally message via social media and email campaigns. The Rally for Medical Research initiative was launched in April 2013 to bring together the entire medical research community to ask Congress to make the NIH a national priority. Through the annual Hill Day, the Rally for Medical Research continues to raise awareness about the critical need for increased investment in the NIH to improve health, spur progress, inspire hope, and save more lives. See the list of the Rally partner organizations.

AACR Patient Advocate Forum: Activating Artificial Intelligence (AI) in Cancer Science and Medicine 

More than 400 advocates and researchers from 30 countries tuned into the latest AACR Patient Advocate Forum to explore artificial intelligence’s (AI) potential to enhance cancer diagnosis, treatment, and prevention. Moderated by Dr. Anna Barker, Ellison Institute of Technology’s chief strategy officer, the forum featured Senior Advisor and patient advocate Asal Sayas from the White House Office of Science and Technology Policy, John Quackenbush from Harvard T.H. Chan School of Public Health, David Spetzler from Caris Life Sciences, and Bob Gatenby from H. Lee Moffitt Cancer Center.  

The discussion highlighted AI’s potential to deconvolute the complexity of cancer in our quest to improve patient outcomes. Panelists noted AI’s ability to integrate large, diverse datasets and identify patterns that hold incredible promise to improve cancer diagnoses, expedite clinical trial matching, and predict treatment outcomes. But panelists cautioned that AI’s success and adoption is contingent on a number of factors. Most notably, these factors include access to high-quality data, preventing bias in data collection, and reimbursement for AI-based technologies.  

With a look to the future, panelists emphasized the need for responsible AI in cancer research and care and called for policy changes to support AI research and ensure equitable access. Patient advocates and scientists are encouraged to work together to define the future of AI and move the field forward for all patients with cancer. 

The recording of the AACR Patient Advocate Forum, Activating Artificial Intelligence (AI) in Cancer Science and Medicine is now available to the public for on-demand viewing. Please mark your calendars for the next AACR Patient Advocate Forum on November 26 to examine and discuss the future of clinical trials. The video is available now to watch.

FDA and AACR Welcome a New Class of Oncology Educational Fellows 

In October 2024, the FDA and the AACR welcomed a new class to the FDA-AACR Oncology Educational Fellowship. This year’s cohort is comprised of 20 early-career scientists, physicians, and pharmacists who are committed to developing innovative and effective treatment options for individuals living with cancer. Now entering its fifth year, this Fellowship aims to advance scientific progress by facilitating the exchange of knowledge in oncology education, fostering collaborative learning, and supporting research efforts. Over the next year, fellows will engage in educational sessions led by experts from the AACR and the FDA on the regulatory process, explore how to design successful clinical trials, and critically analyze various factors that may inform drug approvals. Topics will include expedited pathways, clinical pharmacology, precision oncology, and more. Additionally, fellows will have the opportunity to participate in mentoring and networking opportunities at the AACR Annual Meeting in April 2025, along with a visit to the FDA White Oak Campus for a mock meeting of the Oncologic Drugs Advisory Committee. The AACR looks forward to working with these exceptional early-career investigators. 

FDA Releases Draft Guidance on Multiregional Cancer Clinical Trials 

– Rukiya Umoja, PharmD 

On September 17, the FDA issued new draft guidance on best practices for sponsors to collect clinical evidence for multiregional cancer clinical trials (MRCTs). These trials are conducted across multiple regions under a single protocol, where “region” refers to a geographical sector, country, and areas covered by regulatory agencies. The FDA has signaled that there has been a steady decline in U.S. participants in oncology MRCTs. The guidance, entitled “Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs,” builds on previous guidance documents issued by the FDA. The guidance offers expanded recommendations for the planning, design, conduct, and analysis of an oncology MRCT to ensure adequate representation and applicability of the data to the U.S. population. 

In the guidance, the FDA recommends sponsors utilize a “strategic allocation approach” when developing multiregional trials, based on cancer incidence or prevalence in the U.S., which may include enrollment across several continents. The FDA also encourages sponsors to consider certain factors that may have an impact on treatment response, including exposure risk or genetic background, prevalence of the disease subtype, dietary habits, and cultural beliefs, as well as accessibility to healthcare. Comments on the draft guidance can be submitted until November 18.

U.S. House Members Introduce Resolution to Designate September 16-2​​0 as Medical Research Week

-Blake William Rostine

On September 17, Congressman André Carson (D-IN) introduced H.Res. 1458 to recognize September 16-20, 2024, as Medical Research Week, which would honor the life-saving contributions of the medical research community and the breakthrough discoveries they contribute to.

Joined by fellow House members Joyce Beatty (D-OH), Suzan DelBene (D-WA), Brian Fitzpatrick (R-PA), and Lloyd Smucker (R-PA), this resolution celebrates the medical research community’s dedication to improving the lives of all Americans by conducting cutting-edge research and making breakthrough discoveries which can save lives. Additionally, it highlights the importance of robust NIH funding, which funds this research and gives researchers the necessary tools to continue their work.

The American Association for Cancer Research (AACR) celebrates Congressman Carson and the legislators who have continued their dedication to celebrating the medical research community. This research is essential to ending cancer as we know it and to keeping America as the world’s leader in medical innovations.

U.S. House of Representatives Unanimously Passes the Accelerating Kids’ Access to Care Act

-Blake William Rostine

On September 17, the U.S. House of Representatives unanimously passed the AACR-supported H.R. 4758, the Accelerating Kids’ Access to Care Act. Introduced by Congresswoman Lori Trahan (D-MA) and Congresswoman Mariannette Miller-Meeks (R-IA), this landmark bill would require state Medicaid programs to allow qualifying out-of-state providers to temporarily treat children without additional screenings. For many pediatric cancer patients, this bill creates a pathway that can eliminate unnecessary delays, reduce administrative hurdles, and ensure that children can receive the specialized care they need in a timely manner.

For pediatric patients, who can require specialized treatments, streamlining the care process can be a life-saving measure. The American Association for Cancer Research (AACR) applauds the bipartisan work of the House in passing this important legislation and keeping their promises to aid in the fight against cancer.

This legislation will now move to the Senate, where companion legislation (S. 2373), introduced by Senator Chuck Grassley (R-IA) and Senator Michael Bennet (D-CO), awaits action. The AACR urges the Senate to support this life-saving bill and join their congressional companies in the House to provide children with cancer the tools they need to fight their disease.

ONCOLOGY APPROVAL RECAP 

-Brad Davidson, PhD

Between August 16 and September 20, the FDA approved one novel combination therapy, including one drug receiving its first approval, and four new indications for a previously approved oncology drug: 

  • Lazertinib in combination with amivantamab-vmjw was approved for the first-line treatment of locally advanced or metastatic non-small cell lung cancer with epidermal growth factor (EGFR) exon 19 deletions or exon 21 L858R mutation. This is the first approval of lazertinib for any indication in the United States. The review was performed under FDA’s Project Orbis framework for concurrent review of oncology products by international regulators. Learn more.
  • Atezolizumab and hyaluronidase-tqjs for subcutaneous injection were approved for all adult indications that the intravenous formulation of atezolizumab is already approved for, including indications in non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma. This advance will lower the burden of treatment on patients who opt to use the subcutaneous version, as the traditional intravenous injections take 30-60 minutes while the subcutaneous injection requires only seven minutes. Learn more.  
  • Pembrolizumab was approved in combination with pemetrexed and platinum chemotherapy as a first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma. This application was granted priority review and review was performed under FDA’s Project Orbis framework for concurrent review of oncology products by international regulators. Learn more.  
  • Amivantamab-vmjw in combination with carboplatin and pemetrexed was approved for adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 19 deletions or exon 21 L858R mutations whose disease progressed while on or after treatment with an EGFR inhibitor. This is a new indication for the previously approved amivantamab-vmjw, with review taking place in conjunction with review by international partners through FDA’s Project Orbis collaborative framework. Learn more.  
  • Isatuximab-irfc was approved in combination with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant. Previously approved as a component of treatment for patients who had failed prior courses of therapy, this is the first approval for Isatuximab-irfc in the first line. This application received priority review and orphan drug designation. Learn more.  

To learn more about the approval of other cancer therapies, you can find more information on the FDA’s website, and an American Association of Cancer Research journal, Clinical Cancer Research, regularly publishes FDA approval summaries.