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Highlights

  • PEMGARDA now included in NCCN Guidelines for COVID-19 pre-exposure prophylaxis in B-cell lymphoma
  • Follows prior inclusion in IDSA COVID-19 guidelines for immunocompromised individuals
  • Aims to address reduced vaccine response in high-risk oncology populations

Invivyd, Inc. (Nasdaq: IVVD) announced that its monoclonal antibody PEMGARDA® (pemivibart) has been added to the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for B-Cell Lymphomas. The update identifies PEMGARDA as a potential pre-exposure prophylaxis (PrEP) option against COVID-19 for patients with B-cell malignancies, who often experience diminished vaccine efficacy.

The NCCN’s guideline inclusion reflects PEMGARDA’s role in mitigating COVID-19 risk in moderately to severely immunocompromised individuals, a population that includes many cancer patients undergoing therapies that suppress immune function. This recommendation aligns with guidance issued in August 2024 by the Infectious Disease Society of America (IDSA), which endorsed PEMGARDA for PrEP in eligible patients aged 12 and older.

PEMGARDA is currently available under Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration. It is designed to retain neutralizing activity against circulating SARS-CoV-2 variants and complements existing vaccination strategies for those unlikely to mount a sufficient immune response.

Healthcare providers managing B-cell lymphoma cases are expected to consider this update as they evaluate preventative options for their immunocompromised patients, particularly during ongoing and seasonal COVID-19 activity. The NCCN update may also impact insurance coverage decisions and institutional protocols regarding passive immunization in oncology settings.

No financial guidance or revenue forecasts were issued in conjunction with the announcement. However, the NCCN and IDSA endorsements may influence clinician uptake of PEMGARDA, particularly within specialized cancer centers.

The updated guidelines are publicly accessible via the NCCN website and serve as a reference for treatment decisions based on the latest clinical and real-world data. While Invivyd continues to develop its portfolio of antibody-based therapies, PEMGARDA remains under EUA status and is not fully FDA-approved.