Invivyd, Inc. announced that PEMGARDA^® (pemivibart), its investigational monoclonal antibody, has been added to the National Comprehensive Cancer Network^® (NCCN^®) Clinical Practice Guidelines in Oncology for B-Cell Lymphomas. NCCN joins the Infectious Disease Society of America (IDSA) that updated its COVID-19 guidelines in August 2024 to recommend the use of PEMGARDA (pemivibart) for pre-exposure prophylaxis (PrEP) in moderately to severely immunocompromised adults and adolescents (aged 12 or older) at risk for progression to severe COVID-19 when predominant regional variants are susceptible to pemivibart.

This inclusion in the NCCN Guidelines recognizes PEMGARDA as a potential option for PrEP against COVID-19 in patients with B-cell malignancies. Immunocompromised patients may not mount an adequate immune response to vaccination.

“Managing B-cell lymphoma is inherently challenging for patients, and the added risk of severe COVID-19 further complicates their care,” said George Yaghmour, MD. “The inclusion of PEMGARDA in the NCCN Guidelines is an important development, providing clinicians with a valuable tool to guide treatment decisions. It helps protect vulnerable patients from COVID-19, allowing them to stay out of the hospital, continue their cancer care, and focus on their recovery.”

“We are honored that NCCN has acknowledged the role of PEMGARDA in helping protect one of the most vulnerable patient populations - those with compromised immune systems due to B-cell lymphomas - especially in light of ongoing COVID-19 threats,” said Tim Lee, Chief Commercial Officer at Invivyd. “This recognition reflects the growing confidence in the therapeutic potential of PEMGARDA, and reinforces our commitment to immunocompromised patients including those facing difficult to treat lymphomas, particularly as COVID-19 remains a year-round threat, with another surge expected this summer.”

The NCCN’s recommendation is based on the unmet need in patients with B-cell lymphomas, many of whom experience reduced vaccine efficacy and are at elevated risk for COVID-19-related complications. PEMGARDA is a monoclonal antibody engineered to retain activity against circulating SARS-CoV-2 variants and is currently authorized under Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for PrEP of COVID-19 in certain patients with moderate-to-severe immune compromise.

The updated NCCN Guidelines are now available on the NCCN website and serve as an important resource for oncology providers making evidence-based treatment decisions. They reflect growing clinical and real-world evidence supporting the use of passive immunization to complement vaccination strategies in high-risk oncology populations.

NCCN is a not-for-profit alliance of 33 leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to defining and advancing quality, effective, equitable, and accessible cancer care and prevention so all people can live better lives.