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FDA Spokesperson Gives Insight on Oncologic Drug Evaluation and Product Supply During the COVID-19 Pandemic

Nichole Tucker
Published Online:3:16 PM, Thu March 26, 2020
The spread of COVID-19 has slowed down processes in many areas of health care, and there is widespread curiosity on how the pandemic will impact regulatory action in the United States. In the oncology community, providers and their patients await vital drugs that have been shown to approve upon survival and in some case are considered curative for different cancers.

Since the first week of March when many US states began making declarations about the COVID-19 outbreak, the US Food and Drug Administration (FDA) continued with approvals of isatuximab (Sarclisa) plus pomalidomide (Pomalyst) and dexamethasone in multiple myeloma, as well as the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) in advanced hepatocellular carcinoma. In addition, the FDA granted Breakthrough and Fast Track designations to drugs across multiple malignancies. Since the beginning of March, the number of COVID-19 cases in the country has climbed from 531 to 54,453, with a death toll of 737.2

Although some may expect FDA action to slow down, the regulatory body has actually begun adapting to the changes by taking much of their work virtual.

“FDA is continuing to expedite oncology product development. Our staff is teleworking full time and continuing to meet virtually with drug developers, academic investigators, and patient advocates to push forward the coordinated review of drugs, biologics, and devices for cancer,” an FDA spokesperson said.

In an interview with Targeted Oncology, a spokesperson from the FDA Office of Oncologic Diseases provided insight on how the changes in society during the COVID-19 pandemic are impacting the FDA. The spokesperson also explained how the FDA addresses some of the inevitable challenges during this time.

TARGETED ONCOLOGY: What is the biggest impact that COVID-19 has had on the oncologic drug approval process within the FDA?

FDA: FDA recognizes that the COVID-19 pandemic may impact the conduct of clinical trials of medical products. Challenges may arise, for example, from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with COVID-19. 
The FDA released the “FDA Guidance on the Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic” to assist sponsors and trial sites in addressing these challenges. The guidance states that sponsors should evaluate whether alternative methods for safety assessments (eg, phone contact, virtual visit, alternative location for assessment, including local labs or imaging centers) could be implemented when necessary and feasible, and would be sufficient to assure the safety of trial participants. Sponsors should determine if in-person visits are necessary to fully assure the safety of trial participants (for example to carry out procedures necessary to assess safety or the safe use of the investigational product appropriately). 
In making the decision to continue use or administration of the investigational product, the sponsor should consider whether the safety of trial participants can be assured with the implementation of the altered monitoring approach. If that involves using different sites to deliver the investigational product, an assessment will need to be made regarding whether the alternative site can provide skilled personnel and other resources necessary to appropriately deliver the investigational product. 

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