Invivyd’s PEMGARDA® Receives Significant NCCN Guideline Update
PEMGARDA® Added to NCCN Guidelines for B-Cell Lymphomas
Today, Invivyd, Inc. (Nasdaq: IVVD) proudly announces a significant advancement in the treatment landscape for B-cell lymphomas. The company's investigational monoclonal antibody, PEMGARDA® (pemivibart), has been officially included in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology specifically for B-cell lymphomas. This crucial development has the potential to improve care for a vulnerable patient population affected by cancer and ready to combat COVID-19.
The Importance of PEMGARDA® in Cancer Care
The NCCN Guidelines now recognize PEMGARDA as a promising option for pre-exposure prophylaxis (PrEP) against COVID-19, particularly for those patients with B-cell malignancies. For immunocompromised individuals, vaccination may not yield adequate immune responses, which heightens their risk of severe illness from COVID-19.”
Expert Insight and Patient Protection
Dr. George Yaghmour, a medical expert, shared his perspective, stating, “Managing B-cell lymphoma presents inherent challenges for patients, and the additional threat of COVID-19 complicates their overall care. The inclusion of PEMGARDA in the NCCN Guidelines is invaluable, as it provides clinicians a critical tool to navigate treatment decisions. This ensures vulnerable patients can focus on their cancer recovery, minimizing their risk of COVID-19.”
Commitment to Immunocompromised Patients
Tim Lee, Invivyd's Chief Commercial Officer, expressed pride in this recognition. He stated, “NCCN's acknowledgment of PEMGARDA's role is crucial in helping immunocompromised patients, especially those suffering from B-cell lymphomas, as the risk of COVID-19 persists. This recognition underscores the growing confidence in PEMGARDA's therapeutic potential, highlighting our ongoing commitment to serve patients facing challenging circumstances.”
Clinical Evidence Supporting the Inclusion
The NCCN’s recommendation stems from the urgent need to address the challenges faced by patients with B-cell lymphomas, who often suffer from reduced vaccine efficacy. Designed to retain its activity against various SARS-CoV-2 variants, PEMGARDA is currently authorized for Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration for prevention in patients with moderate to severe immune compromise.
NCCN Guidelines as an Essential Resource
The updated NCCN Guidelines are now publicly accessible and serve as a vital reference for oncology professionals. They demonstrate the increasing clinical and real-world evidence advocating for passive immunization strategies to augment vaccination efforts in high-risk oncology groups.
Understanding PEMGARDA®
PEMGARDA (pemivibart) is a novel investigational monoclonal antibody engineered for a half-life extension, offering significant promise in managing viral infectious diseases. Constructed from adintrevimab, which has demonstrated robust safety and efficacy in clinical trials, PEMGARDA has shown capacity to neutralize major SARS-CoV-2 variants effectively.
Administration and Safety of PEMGARDA®
PEMGARDA, administered through an intravenous injection, is currently an investigational product, though authorized for emergency use. Notably, it is designed for those who have moderate to severe immune compromise and may not respond adequately to vaccination. Furthermore, administration guidelines specify PEMGARDA should be given at least two weeks post-vaccination, ensuring patient safety.
Future Outlook and Ongoing Research
Invivyd remains committed to advancing anti-viral therapies, particularly in response to emerging COVID-19 variants. Current research efforts focus on ensuring that PEMGARDA retains its effectiveness, especially in combating new variants. Despite some limitations related to available data, evidence supports the continued evaluation of this promising treatment.
Invivyd’s Pioneering Role in Viral Defense
As a biopharmaceutical entity, Invivyd (Nasdaq: IVVD) is dedicated to protecting against serious viral infections. The company uniquely utilizes an integrated technology platform to develop world-class antibodies. The recent EUA granted to one of Invivyd’s mAb candidates indicates a positive trajectory towards innovative treatment solutions in ongoing efforts against COVID-19.
Frequently Asked Questions
What is PEMGARDA® and its purpose?
PEMGARDA is an investigational monoclonal antibody designed for pre-exposure prophylaxis against COVID-19, especially for patients with compromised immune systems, such as those with B-cell lymphomas.
Why is the NCCN inclusion important?
This inclusion highlights the need for additional protective measures for immunocompromised patients, ensuring they have valuable treatment options amidst ongoing COVID-19 risks.
How does PEMGARDA® work?
PEMGARDA targets the SARS-CoV-2 spike protein, facilitating inhibition of the virus's ability to bind to human cells, thus preventing infection.
What future developments are expected with PEMGARDA®?
Continuous research aims to ensure that PEMGARDA maintains efficacy against emerging SARS-CoV-2 variants and further support its use in vulnerable patient populations.
How can patients learn more about PEMGARDA®?
Patients can find detailed information by consulting with their healthcare providers or accessing resources provided by Invivyd on their official website.
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