On January 26, 2023 the U.S. Food and Drug Administration (FDA) removed its emergency use authorization (EUA) of tixagevimab/cilgavimab (Evushield) for the prevention of SARS-CoV-2 infection after exposure to the virus. FDA said it made the decision because the agent is not effective in preventing infections from the current variants that are responsible for 90% of today’s infections and because the risks of the drug’s side effects do not outweigh the benefits.
FDA recommended that people who are exposed to someone with confirmed SARS-CoV-2 infection are immediately report any symptoms of COVID-19 to their healthcare provider and obtain testing. ritonavir-boosted nirmatrelvir (Paxlovid™), remdesivir (Veklury®), and molnupiravir (Lagevrio™) remain authorized for treatment of mild to moderate COVID-19 in those at high risk for progression to severe disease, including those with cancer.
Recommendations for Infection Prevention in Patients With Cancer
Patients with cancer are especially high risk for complications and hospitalization associated with a COVID-19 infection. Without an EUA for a prevention medication, the focus returns to infection prevention strategies. The Centers for Disease Control and Prevention recommends that people with a weakened immune system who are most vulnerable to COVID-19 infection should:
- Receive an updated COVID-19 vaccination.
- Stay in well-ventilated and outdoor spaces when possible.
- Know about available testing locations and treatment options prior to infection.
- Get tested in the event of exposure or if symptoms emerge.
- Wash their hands often.
- Wear a well-fitting mask and maintain spacing in crowded places.
Recommendations for Healthcare Providers
As SARS-CoV-2 variants and their associated data change, tixagevimab/cilgavimab may be effective in preventing infection in those exposed to new variants. FDA recommended that healthcare sites retain their supply in accordance with the drug’s recommended storage conditions. The agency is monitoring current variants and tixagevimab/cilgavimab’s role in preventing infection postexposure.
Providers should assure patients who have already received one or more doses of tixagevimab/cilgavimab that the authorization removal is not related to safety but rather efficacy in preventing infections from the most recent virus variants.