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Cancer Policy Monitor: August 11, 2020

AACR Mourns the Loss of John Lewis

Congressman and Civil Rights Icon John Lewis passed away July 17 from complications related to pancreatic cancer. He was 80 years old. The AACR put out a statement honoring his life and accomplishments. Click to view the statement in its entirety.

Appropriations Update from Capitol Hill

-Brandon Leonard, MA

As COVID-19 cases rise in many parts of the country, much of the focus on Capitol Hill has been on passing a fifth emergency supplemental package to respond to both the public health and economic impacts of the pandemic. The House passed its $3 trillion relief bill, the HEROES Act in May, but that legislation had no chance of moving in the Senate. More recently, Senate Republicans have been negotiating details of their own package with the White House. As of July 27, no deal had been reached. However, Congress is expected to negotiate and pass supplemental legislation before leaving for August recess. The AACR and others in the medical research advocacy community continue to urge Congress to include at least $10 billion in emergency funding for the NIH to support reopening labs and restarting research, including clinical trials, that has been impacted by COVID-19 closures. Additional funding is also needed for COVID-19 specific research.

Meanwhile, the fiscal year (FY) 2021 appropriations process is well underway, with the House aiming to clear all of its spending bills before the August break. The House Labor-Health and Human Services (HHS)-Education Subcommittee approved its bill on a party-line vote on July 7, and the full House Appropriations Committee approved the measure on July 13. The bill includes $47 billion for the NIH, an increase of approximately $5.5 billion over FY 2020. However, the majority of the increase ($5 billion) is provided as emergency funding which would be available over the next five years. The base annual increase would be $500 million, and that amount is further reduced by transfer authority for building and facility projects. Appropriators were constrained by very restrictive budget caps that allowed for only $5 billion in increased funding across all non-defense discretionary programs in FY 2021. The Labor-HHS-Education bill is expected to pass the House as part of a “minibus” or package of appropriations bills.

The Senate has not yet begun marking up its appropriations bills for FY 2021 and is not likely to do so before September. It is widely expected that a continuing resolution will be needed to ensure funding across the federal government starting October 1, as Congress is unlikely to complete its work on appropriations bills before the end of the fiscal year on September 30.

Register Today! Rally for Medical Research 2020 Virtual Hill Day

Registration is now open for the eighth annual Rally for Medical Research, which will be held September 16-17, 2020, as an entirely virtual event. The health and safety of all Rally participants is the top priority in organizing this event, and due to the COVID-19 pandemic, we are unable to gather in person on Capitol Hill this year. However, it is as important as ever that we all join together in urging Congress to prioritize medical research funding.

Therefore, this year’s Rally events will all be held virtually. This format will allow as many people as possible to participate, and we look forward to making this the biggest Rally for Medical Research ever!

A virtual reception with exciting speakers is being planned for the evening of Wednesday, September 16, while the virtual Hill Day meetings on September 17 will be held with congressional offices via phone and webinar. We will hold a training session for all participants the week prior to the Hill Day. As in previous years, there will also be an online Rally National Day of Action. Stay tuned to the Rally website for more information as it become available. We look forward to your (virtual) participation in September!

Virtual COVID-19 and Cancer Meeting Explores Pandemic Impact on Cancer Research

On July 20-22, the AACR hosted the AACR Virtual Meeting: COVID-19 and Cancer. Along with cutting-edge science at the intersection of COVID-19 and cancer, the conference included several forums discussing the impacts of the pandemic on research, clinical trials, and patients with cancer.

Recurring themes over the three-day meeting included using lessons learned during the COVID-19 health crisis to reform clinical trials; building on the spirit of open science that blossomed during the pandemic to explore new avenues for collaboration; addressing the health disparities and inequities apparent in both COVID-19 and cancer; and ensuring the safety of all patients.

You can read more about this conference on the AACR Cancer Research Catalyst including summaries of the conference’s keynote presentations from Anthony Fauci, Solange Peters, and Trevor Bedford.

FDA Stops the Sale of 13 Tobacco Products

Carmine S. Leggett, PhD

Since 2009, under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), the Food and Drug Administration (FDA) regulates tobacco products based on a public health standard intended to reduce detrimental public health effects of tobacco. To legally market a new tobacco product in the U.S., a manufacturer must receive a written order from the FDA. Given this authority there are three pathways to market for tobacco products: Premarket Tobacco Product Applications (PMTA), Substantial Equivalence (SE), and Exemption from Substantial Equivalence.

In May 2020, FDA issued Not Substantially Equivalent (NSE) orders for 13 tobacco products that had been provisionally permitted to be sold on the market since 2011. Consequently, these tobacco products can no longer be distributed, imported, sold, marketed or promoted in the U.S. Among others, the 13 products include dissolvable tobacco products (i.e., orbs, sticks, and strips) which contain pieces of compressed powdered tobacco, similar to small hard candies, dissolve in the mouth and require no spitting of tobacco juices. These products are often confused with nicotine lozenges used for smoking cessation; however they are not the same. Data indicate that not only can levels of unprotonated nicotine in dissolvable products vary significantly by regions, but some regional variations in tobacco-specific N-nitrosamines (TSNA) levels were also observed. Overall, Camel Snus had significantly higher TSNA levels. Researchers found that the amount of unprotonated nicotine in the dissolvable Camel products was comparable to the levels found in Marlboro Snus.

The FDA asserts that retailers with remaining inventory of the combustible cigarette and smokeless tobacco products that received NSE orders should work with the product manufacturer or supplier to discuss options for disposing of these products. Failure to comply with the Federal Food, Drug and Cosmetic (FD&C) Act may result in FDA taking regulatory action without further notice. These actions may include, but are not limited to, civil money penalties, seizure, and/or injunction.

FDA Removes Flavored Disposable E-Cigarettes and E-Liquids that Appeal to Youth from the Market

-Carmine S. Leggett, PhD

In 2019, 6.2 million middle and high school students used tobacco products, with e-cigarettes being the product most commonly used. The U.S. Food and Drug Administration (FDA) is acting against illegally marketed tobacco products to eliminate the youth vaping epidemic in the U.S. As with many public health advocates, the FDA is concerned about the appeal of flavored, disposable e-cigarettes to youth and continues to monitor all available data. The FDA notified ten companies, including Cool Clouds Distribution Inc. or Puff Bar to remove their flavored disposable e-cigarettes e-liquid products from the market, asserting that the companies do not have the required premarket authorization. Three firms received warning letters for illegally marketing disposable e-cigarettes—Puff Bar, HQD Tech USA LLC and Myle Vape Inc. The FDA’s review of the companies’ websites revealed that each firm is selling or distributing unauthorized tobacco products that were first introduced or modified after August 8, 2016—the effective date of the deeming rule that extended the FDA’s authority to all tobacco products. Additionally, FDA issued seven other warning letters to the following firms: Eleaf USA, Vape Deal LLC, Majestic Vapor LLC, E Cigarette Empire LLC, Ohm City Vapes Inc., Breazy Inc. and Hina Singh Enterprises (doing business as Just Eliquids Distro Inc.), who sell or distribute unauthorized e-cigarette products targeted to youth or likely to promote use by youth. These firms were cited for marketing unauthorized e-liquids that imitate packaging for food products.  

Lung Cancer Screening Recommendations Expanded

Nicholas Warren, PhD

Every year over 200,000 patients are diagnosed with and 130,000 patients die from lung cancer in the United States. According to the National Institutes of Health’s Surveillance, Epidemiology, and End Results Program, patients with lung cancer who receive a diagnosis before the cancer has spread have a 59 percent chance of living 5 years compared to 5.8 percent of patients who are diagnosed after lung cancer has spread to distant sites. Therefore, detecting aggressive lung cancers early can significantly improve the chances that surgery and therapies will effectively treat the disease and save a patient’s life. However,  >90 percent of lesions identified by lung cancer screening are not actually cancerous. It is important to screen people with high risk of lung cancer to maximize the benefits of screening while minimizing false positives and unnecessary follow up procedures.

The premier organization that sets cancer screening guidelines in the United States is the U.S. Preventative Services Task Force (USPSTF), which is a volunteer panel of esteemed independent scientists. The USPSTF carefully weighs the best available evidence of benefits and risks when creating guidelines, and reconsiders guidelines when new evidence becomes available. In 2014, the USPSTF issued guidelines recommending low dose computed tomography (CT) lung cancer screening for smokers between the ages of 55-80 years and who have a smoking history of a pack a day for 30 years. The guidelines also included former smokers who meet the age and smoking criteria and quit within the past 15 years. The randomized National Lung Screening Trial (NLST), which compared low dose CT and standard chest X-rays in 53,454 current and former smokers aged 55-75 years and with more than 30-pack year history of smoking. NLST found low dose CT decreased the risk of dying from lung cancer by 20 percent, and all-cause mortality by 6.7 percent, compared to standard chest X-ray. However, this study has been criticized for low representation of racial and ethnic minorities. Furthermore, only 17 percent of African American smokers were eligible for lung cancer screening under the 2014 USPSTF guidelines, compared to 31 percent of White smokers. This disparity is likely due to lower average pack-years of smoking history among African American smokers.

A new screening trial published in February 2020 led the USPSTF to update their guidelines this July. The Nederlands-Leuvens Longkanker Screenings Onderzoek (NELSON) trial included 15,789 patients as young as 50 years and with as little as a 20 pack-year history of smoking. The NELSON trial found that low dose CT screening decreased the risk of death from lung cancer by 24 percent over 10 years. This evidence suggests that many more smokers could benefit from lung cancer screening than previously thought. With this new evidence, the USPSTF proposed decreasing the minimum age for screening eligibility from 55 to 50 years and lowered the minimum smoking history from 30 to 20 pack-years.

Despite evidence of benefit and these guidelines, very few patients are screened for lung cancer. The National Cancer Institute estimated that only 5.9 percent of eligible smokers underwent lung cancer screening in 2015. Additionally, only 0.7 percent of eligible Hispanic smokers underwent lung cancer screening in 2015. While Medicare, Medicaid, and most private insurance plans cover the costs of screening for patients who meet the 2014 guidelines, many barriers still exist, such as: lack of awareness among patients and providers; fears of a cancer diagnosis and treatment-related costs; lack of health insurance, and; transportation burdens.  Expanding insurance coverage to patients who meet the new guidelines and removing other barriers will be critical to improving screening rates and saving lives.

Dialogues with Patient Advocates

Patients with cancer provide invaluable insight on issues facing the cancer research community. The AACR Patient Advocacy Program developed the interview series, Dialogues to showcase unscripted discussions between patient advocates, cancer survivors, researchers, and physicians on current topics. The series was recently relaunched as a video series and we are pleased to share the first two installments.

Dialogue: COVID-19 and Cancer, is a discussion between patient advocates Adam Hayden who has been living with a glioblastoma (GBM) brain tumor since 2016, and Janet Freeman-Daily, who was diagnosed with non-small cell lung cancer in May of 2011. The Dialogue addresses the impact of COVID-19 on cancer treatments, cancer research, and overall quality of life.

Dialogue: Lung Cancer,is a discussion between patient advocates, lung cancer survivors, and co-founders of the EGFR Resistors, Ivy Elkins and Jill Feldman. The Dialogue addresses the stigma of a lung cancer diagnosis, highlights recent advances in the field, and provides a perspective on the future of lung cancer research.

Application Period Open for New FDA-AACR Oncology Educational Fellowship

During his remarks at the AACR Virtual Annual Meeting II Opening Ceremony, Richard Pazdur, MD, director of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE), announced that the AACR and OCE have partnered on a new initiative to provide early-career cancer researchers and fellows with a unique opportunity to learn more about oncology drug development and the regulatory review process. The FDA-AACR Oncology Educational Fellowship offers targeted educational activities and interactions with experts from the AACR and the OCE. Applications are being accepted until August 15, 2020.

Eligible candidates must have an advanced degree (MD, PhD, or MD/PhD), be within five years of starting their current academic position, and be or have applied to become AACR members. Neither U.S. citizenship nor residency are required to apply, but candidates must be proficient in English. It is anticipated that 10-15 fellows will be selected.  

Fellows will participate—remotely, for now—in educational events on topics such as investigational new drugs (INDs), expedited approval pathways, clinical pharmacology, clinical trial design, companion diagnostics, and animal studies. These virtual sessions will be a mix of didactic content presented by FDA OCE experts and group discussions. There will be additional activities for fellows related to the 2021 AACR Annual Meeting and the 2021 Accelerating Anticancer Agent Development and Validation Workshop.

Learn more on the fellowship webpage or email Trevan Locke, PhD, Regulatory Science and Policy Analyst, with questions.

Save the Date: Release of the Inaugural AACR Cancer Disparities Progress Report

The AACR will release its inaugural Cancer Disparities Progress Report during a virtual briefing on Wednesday, September 16.

This report will feature the latest research on why disparities in cancer incidence, diagnosis, treatment, and survival exist, and what can be done to address them. The report has been developed by the preeminent cancer disparities researchers in the country and builds upon the AACR’s longstanding commitment to reducing cancer disparities through research, including our annual conference on the Science of Cancer Health Disparities.

Register Today

Save the Date: Release of the AACR Cancer Progress Report 2020

The annual AACR Cancer Progress Report to Congress and the American public is a cornerstone of the efforts of the AACR to educate the public about cancer and the importance of biomedical research, as well as to advocate for increased federal funding for the NIH, NCI, FDA, and CDC. This year’s report chronicles how federally funded research continues to save and improve lives, and it shows that our ability to fully capitalize on our ever-growing knowledge of cancer is dependent on robust, sustained, and predictable federal funding.

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Oncology Approval Recap

Between June 27 and July 27, the U.S. Food and Drug Administration approved one novel therapy and four expanded indications for oncology drugs:

  • A new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase–zzxf was approved for the following indications:
    • Use in combination with chemotherapy as:
      • neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer;
      • adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.
    • Use in combination with docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
  • Pembrolizumab was approved for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
  • Avelumab was approved for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.
  • An oral combination of decitabine and cedazuridine was approved for adult patients with myelodysplastic syndromes (MDS) including the following:
    • previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and
    • intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
  • Brexucabtagene autoleucel was granted accelerated approval for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

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