Ask An Expert, Public Webinar Part 3 - Multiple Myeloma, the FDA, and the Future with COVID-19

The patient support discussion will be based around importance of early cancer screening for people at risk, health disparities in Multiple Myeloma, and the FDA's current efforts to address COVID-19 in cancer treatments.


Panelists

Dr. Irene Ghobrial

Multiple Myeloma Hematologist and Co-Director, Center for Prevention of Progressive Blood Cancers, Dana Farber Cancer Institute; Principal Investigator, The PROMISE Study and Professor of Medicine, Harvard Medical School


Dr. Nichole Gormley

Hematologist and Acting Director for the Division of Hematologic Malignancies, Food and Drug Administration (FDA)


Dr. Bindu Kanapuru

Medical Officer for the FDA’s Center for Drug Evaluation and Research in the Office of Hematology and Oncology Products


Summary

In this third installment of Ask An Expert: Myeloma Panel Series, panelists discuss the importance of early cancer screening for at-risk populations, health disparities in multiple myeloma and the FDA’s current efforts to address COVID-19 in oncology treatments.


Topics and Time Code

Defining MGUS and Smoldering Myeloma, and Multiple Myeloma and Understanding the Difference (4:15)

  • Overview of the PROMISE and PCROWD Studies, current findings, and role they play in studying the importance of blood cancers screenings

  • Importance of providing blood screening opportunities to African Americans and those of African descent and the benefit of an early diagnosis

FDA’s Role in Disparities Research and Hematological Malignancy Research (13:38)

  • Different branches of the FDA

  • FDA’s guidance for conducting clinical trials during COVID-19

  • Supporting geriatric patients’ participation in clinical trials during COVID-19 and increasing their overall enrollment in clinical trials

  • Use of telemedicine in clinical trials such as the PROMISE and PCROWD Studies

FDA’s Drug Approval Process and How it Relates to COVID-19 (26:10)

  • The Role of FDA’s Division of Hematological Malignancies in assessing and approving new treatments

  • Promoting the public health aspect of clinical drug development

  • Use of oral treatments over injections and infusions during COVID-19

  • FDA’s Coronavirus Treatment Acceleration Program

  • FDA’s Covid-19 Evidence Accelerator

Treatment and Research on Hematological Malignancies (38:53)

  • Multiple myeloma and its precursor conditions and their impact the body’s immune systems

  • Impact of COVID-19 on the immune system for someone with precursor conditions and the potential for faster progression to multiple myeloma

  • Upcoming study opportunity for PROMISE and PCROWD Study participants will explore impact of COVID-19 on precursor conditions to multiple myeloma

  • COVID-19 vaccines and potential to protect patients with multiple myeloma and its precursor conditions

Participant Q&A (46:25)

  • If patients with multiple myeloma or its precursor conditions think they have COVID-19 symptoms what should they do?

  • How do the COVID-19 tests work?

  • What causes progression from precursor conditions to multiple myeloma?

  • When does a hematologist recommend a bone marrow biopsy for a person with a precursor condition?

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