Greetings from FDA Oncology!
Welcome to the July 2024 edition of the FDA Oncology Center of Excellence (OCE) quarterly newsletter from Project Community. This newsletter provides a summary of OCE's upcoming public events, educational opportunities, and recent oncology product approvals. These are free and everyone is welcome. Watch for updates throughout 2024 and send your suggestions to OCE-Engagement@fda.hhs.gov.
Center Director's Message
Patients, Advocates and Families,
It’s been a busy summer at OCE. We are grateful for all the advocates who came out to meet with some 20 FDA OCE staff in June during the Project Community patient advocates meeting at the American Society of Clinical Oncology conference. The session took place in Chicago appropriately on National Cancer Survivors Day.
Shortly thereafter, OCE’s 4th Annual National Black Family Cancer Awareness Week got underway. Thanks to you and other interested groups, there was enthusiastic social media involvement during the week leading up to the Juneteenth holiday. Can we do even better for next year’s fifth anniversary of #BlackFamCan?
Meanwhile, the inaugural National Hispanic Family Cancer Awareness Week begins soon. OCE Project Community will host a live streamed public panel discussion September 20, 2024, at 11am ET, followed by a weeklong bilingual social media campaign, #LatinePuede! We hope you register to watch the “Conversation on Cancer” and participate in spreading cancer awareness through this campaign.
As always, we appreciate opportunities to engage with you and value your feedback. Most recently, we received this comment from Rush University’s Associate Director of Engagement Paul Galchutt after the July 10 Conversation on Cancer public panel discussion: “[Participating in] 'Exploring Religious Literacy and Spirituality in Cancer Care' was like the webinar version of flying in first class.” Thank you, Paul! OCE is grateful for the myriad of panelists and patients who serve as scientists, survivors, and personal storytellers bearing witness along the cancer continuum.
Sincerely,
Richard Pazdur, MD • OCE Director
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Upcoming Events
Conversations on Cancer: National Hispanic Family Cancer Awareness Week
 Registration is now open for the free Conversations on Cancer public panel discussion on September 20, 2024, highlighting National Hispanic Family Cancer Awareness Week. Visit our webpage to learn more!
OCE's Project Community will hold the inaugural National Hispanic Family Cancer Awareness Week on September 20-26, 2024. The week will feature a Conversation on Cancer public panel discussion on September 20, and a social media campaign throughout the week using the hashtag #LatinePuede!
The purpose is to increase cancer awareness within the Hispanic population. National Hispanic Family Cancer Awareness Week aims to gather community-based groups to increase cancer awareness and build knowledge surrounding cancer clinical trial participation as well as increasing understanding of ways to contribute to national genetic databases for cancer research.
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Friday, September 20 – Register and virtually attend the Oncology Center of Excellence (OCE) Conversation on Cancer public discussion.
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Saturday, September 21 - Learn more information about cancer disparities.
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Sunday, September 22 – Discuss your family’s cancer history.
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Monday, September 23- Learn how environment risks impact cancer development.
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Tuesday, September 24 – Learn more about cancer research and clinical trials.
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Wednesday, September 25, - Provide support to patients, caregivers, and patient advocates/navigators.
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Thursday, September 26 – Understand and support cancer quality of life and cancer survivorship.
Working or too busy to watch Conversations on Cancer? Catch up by viewing past events posted on the Conversations on Cancer web page!
ICYMI (In Case You Missed It)
Conversations on Cancer
July 11, 2024: Cancer Cabinet Community Conversation: Cancer Moonshot: What has happened at OCE since 2017? Watch on YouTube. Learn more about OCE in this special edition of Conversations on Cancer on our role in connection with the Cancer Moonshot. Since the inception of the Center in 2017, the OCE has established over 40 programs to improve cancer drug development and engage in stakeholder outreach including with patient groups, academia, global regulators, and industry. Learn how the Center unites experts across the FDA to conduct expedited review of medical products for oncologic and hematologic malignancies.
July 10, 2024: Exploring Religious Literacy and Spirituality in Cancer Care. Watch on YouTube. This edition of Conversations on Cancer began with a brief exploration of the difference between religion and spirituality. We focused on patients’ experience with their spirituality during cancer care and addressed how the religious literacy and spirituality of their providers may affect this care. Special interest: how good spiritual care and religious literacy improves communication between providers and patients, especially underserved patients.
June 13, 2024: 4th Annual National Black Family Cancer Awareness Week, Engaging the Generations. Watch on YouTube. The 4th annual public panel discussion on National Black Family Cancer Awareness Week was the lead event for the weeklong social media campaign. Under Project Community, OCE encouraged a wide array of community-focused engagement entities, organizations, and families throughout the US to support cancer awareness by advancing greater equity in global cancer outcomes using #BlackFamCan.
April 23, 2024: Strength in Numbers: Increasing Cancer Awareness While Decreasing Disparities. Watch on YouTube. OCE encourages community-based cancer reduction and prevention and efforts to enroll a diverse clinical trial population. Many minority-supported cancer advocacy groups are working to educate patients and families about cancer screening and clinical trial participation, and providing patient navigation support. This installment of Conversations on Cancer is dedicated to them in recognition of National Minority Health and National Cancer Control Month.
Patients and Advocates at Recent Meetings
 Above and below: Project Community brought patients and advocates together with FDA staff for the annual OCE Advocates Session at the ASCO Annual Meeting in Chicago in June.
 Attention Pediatric Cancer Advocacy Community!
You’re invited to join the join the FDA Oncology Center of Excellence Pediatric Advocacy Forum on Tuesday, October 15, 2024, from 9 am to 1 pm ET. The forum will provide an opportunity for informal dialogue between FDA staff involved in overseeing development of new products to treat pediatric cancers and the advocacy community.
Further details:
Getting to Know You!
In this issue we are pleased to highlight Angela Stanley.
I’m a cancer survivor from Cabell County, West Virginia. My advocacy journey with the American Cancer Society Cancer Action Network, ACS CAN, began in 2005.
What are you currently working on that makes you feel excited or proud?
I have a heart for reassuring people facing cancer. I’ve seen the health disparities that many cancer patients are experiencing in Southern WV and have spoken publicly about the need for greater cancer care equity. I also enjoy working with veterans.
What has your experience been working with the Oncology Center of Excellence, Project Community?
Thanks to my association with the American Cancer Society Cancer Action network, I was recruited to participate with Project Community in July 2023. I served as a patient panelist in the “Conversations on Cancer – Cancer Disparities in Appalachia” public panel discussion. My primary message as a patient advocate was, regardless of a person’s zip code, people deserve access to early detection, quality cancer care and treatment, and hope for a cure.
Please share any advice you or your organization have for other advocates.
I was diagnosed with breast cancer at 44, during my son’s senior year of high school. Throughout my diagnosis and treatment, I found an outlet in poetry as well as my desire for cancer advocacy. Rather than viewing the cancer diagnosis as a death sentence, I viewed it as God providing me a new opportunity to encourage and support others facing cancer not to give up.
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Each newsletter will highlight a Project Community advocate we have had the privilege of engaging with. If you would like to nominate your organization, or for any additional information, please reach out to us at OCE-Engagement@fda.hhs.gov. Use: Newsletter Nomination for Getting to Know You in the subject line.
Getting to Know OCE!
Mitchell Chan, PharmD, BCPS, is a clinical analyst and team lead for OCE’s Project Facilitate, a comprehensive program dedicated to oncology single patient expanded access. He is also a Lieutenant Commander in the US Public Health Service, dedicated to advancing, promoting, and protecting the nation’s health through his many deployments for humanitarian missions and natural disasters including COVID-19.
As a clinical analyst for Project Facilitate, Lt. Cmdr. Chan manages a national call center and email inbox, answering inquiries and performing reviews of the oncology single patient expanded access applications that come in through phone or email. His passion for data science has revolutionized the way Project Facilitate collects, manages, and reports data to the public and leadership.
Prior to Project Facilitate, Lt. Cmdr. Chan was a pharmacist provider in family medicine and urgent care in the Indian Health Service in New Mexico. He joined the FDA in 2018 as a Regulatory Project Manager in the Division of Oncology Products 1. He received his Doctor of Pharmacy from the University of New England in Portland, ME, completed a PGY1 Pharmacy Practice Residency at South County Health in Rhode Island, received his Pharmacist Provider training from University of New Mexico, and is currently formalizing his skills in statistics and data science through a Master of Science in Data Analytics from the University of Maryland Global Campus.
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Facts about FDA
True or False? FDA incorporates patient input during the oncology drug and device development and review process.
True! FDA regularly engages with patients and caregivers about FDA-regulated products. To inform our priorities and decisions, we gather information about the patient experience through many different patient engagement programs.
For more information, visit OCE's Project Community to learn more about patient engagement at the FDA.
 June 26: Epcoritamab-bysp is for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Accelerated Approval.
June 21: Adagrasib in combination with cetuximab is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
June 14: Bilinatumomab is for adult and pediatric patients one month and older with CD19 positive Philadelphia-chromosome negative B cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy.
May 16, 2024: Tarlatamab-dlle is for adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy. Accelerated Approval.
Learn more about how to use product labeling and browse or search the full list of FDA oncology approvals.
 August
- World Lung Cancer Day (August 1, 2024)
September
- Childhood Cancer Awareness Month
- Leukemia and Lymphoma Awareness Month
- Ovarian Cancer Awareness Month
- Prostate Cancer Awareness Month
- Thyroid Cancer Awareness Month
- Uterine Cancer Awareness Month
- Gynecologic Cancer Awareness Month
- Blood Cancer Awareness Month
October
- Breast Cancer Awareness Month
- Liver Cancer Awareness Month
- National Mammography Day (October 18, 2024)
November
- Carcinoid Cancer Awareness Month
- Gastric Cancer Awareness Month
- Lung Cancer Awareness Month
- Pancreatic Cancer Awareness Month
- Lung Cancer Awareness Month
- National Family Caregiver Month
- Stomach Cancer Awareness Month
Brought to you by Project Community
Project Community is a public health outreach initiative established by the FDA Oncology Center of Excellence for patients living with cancer, survivors, advocates, families, and people living in underserved urban and rural communities who are at greater cancer risk. Our goal is to increase communication between the underserved and medical professionals in communities nationwide, to foster understanding, and awareness to reduce cancer risk and increase survival.
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