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.
The spread ofCOVID-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 ofisatuximab (Sarclisa) plus pomalidomide (Pomalyst) and dexamethasone in multiple myeloma, as well as the combination ofnivolumab (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 531to 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 withTargeted 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.
TARGETED ONCOLOGY: Since some clinical trial enrollment is halted, will some approvals be put off? If not, what challenges exist with continuing business as usual?
FDA: There are many different health care settings across the United States and the world where clinical trials are conducted. While FDA does not regulate routine health care delivery or practice of medicine, we are fully supportive of interventions that may improve the safety of patients in the context of the COVID-19 pandemic.
While patients being treated for cancer may be at increased risk due to the morbidity of their disease and/or [adverse] effects from their treatment, strategies to mitigate coronavirus exposure and challenges related to space, staff, or supply shortages are not unique to cancer care or cancer clinical trials. FDA is working across all therapeutic areas to assure patient safety in the clinical trial setting.
TARGETED ONCOLOGY:What advice can you give to physicians who are waiting for groundbreaking oncology treatments to enter community clinics?
FDA: 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.
We continue to process Expanded Access requests for investigational products. Project Facilitate remains open at (240) 402-0004 orONCProjectFacilitate@fda.hhs.govfrom 8 AM to 4:30 PM Eastern time, Monday through Friday, to assist oncology health care providers and regulatory professionals in requesting access to investigational therapies for patients for the treatment of cancer when no satisfactory therapies are available and there is no opportunity for the patient to enroll in a clinical trial. For after-hours emergency requests, contact FDA’s Emergency Call Center at 1-800-300-4374. Health care providers caring for patients with cancer and COVID-19 who are seeking an investigational treatment specifically to treat COVID-19 should contact the Division of Antivirals or the Center for Biologics Evaluation and Research
directly to request access. Patients and caregivers who need information about accessing investigational therapies may contact the Division of Drug Information at (301) 796-3400 or email firstname.lastname@example.org.
TARGETED ONCOLOGY: How is the Oncologic Drug Advisory Committee continuing activity during this time? What are the key items the committee is working on?
FDA: As this remains a dynamic situation, we will continue to assess and calibrate our approach. Where possible, the agency will leverage technology to host meetings allowing for remote participation. We thank you for your patience.
In considering necessary steps for protecting public health, including our sponsors, our committee members and our workforce, we are cancelling or postponing all non-essential meetings through the month of April. We will reassess on an on-going basis for future months. Where possible, the agency will leverage technology to host meetings allowing for remote participation.
TARGETED ONCOLOGY: Since some borders have been closed due to the spread of COVID-19, how has this impacted the US supply chain for investigational and approved oncologic drugs from other countries? Are there any actions being taken to improve upon the issue?
FDA:The FDA is keenly aware that the outbreak could impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the US FDA staff have been proactively reaching out to manufacturers as part of our vigilant and forward-leaning approach to identifying potential disruptions or shortages. We are also coordinating closely with our HHS partners (Centers for Disease Control and Prevention and
Assistant Secretary for Preparedness and Response) on supply chain issues at the distributor, manufacturer, state, and facility levels. We have been in contact with hundreds of manufacturers of human and animal drugs and medical devices, as well as syncing up with global regulators, like the European Medicines Agency, to assess and monitor for indications and early warning signs of potential manufacturing discontinuances or interruptions due to the outbreak.
TARGETED ONCOLOGY: Is there anything else you think is important for community oncologists to know about drug approvals and FDA action at this time?
FDA: We will continue to inform the cancer community. Our work to improve education, resources, outreach, and communications regarding cancer product development continues unabated. We encourage you to follow @FDAOncology on Twitter and check our website for regular updates. We realize this is a stressful time for all Americans, but especially those with cancer, a life-threatening illness requiring the need for ongoing access to health care services.