Cervical Cancer : NERLYNX® Added to NCCN Guidelines for HER2-Mutation
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company focused on advancing cancer treatments, has announced that the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Cervical Cancer have been updated to include neratinib (NERLYNX®) as a recommended therapy. This update incorporates neratinib as a second-line or subsequent treatment option for patients with recurrent cervical cancer or metastatic cervical cancer with HER2 mutations, under a Category 2A designation. This category indicates that the treatment is “useful in certain circumstances,” providing an important option for patients with HER2-mutated cervical tumors.
The inclusion of neratinib in the NCCN Guidelines is based on promising results from the Phase II SUMMIT trial (NCT01953926). This trial enrolled patients with recurrent who had no available curative treatment and tested neratinib on those with documented HER2 mutations. The findings, published in Gynecologic Oncology in December 2023, highlighted neratinib’s potential in targeting HER2 mutations, which are found in approximately 9%.
Alan H. Auerbach, CEO and President of Puma Biotechnology, expressed satisfaction with neratinib’s inclusion in the NCCN guidelines, emphasizing that these guidelines are a trusted resource for healthcare providers to determine optimal cancer treatment. Auerbach believes that this recognition will raise awareness and help cervical cancer patients, their caregivers, and healthcare professionals make more informed decisions when treating advanced cervical cancer.
HER2-Mutated Cervical Cancer
Despite recent advancements in treatments for cervical cancer, there remains a significant unmet need for targeted therapies, particularly for recurrent and metastatic forms of the disease. Somatic HER2 mutations have been identified in up to 9% of cervical cancer cases, correlating with worse patient outcomes. These mutations present an opportunity for targeted therapies, like neratinib, which specifically inhibits HER2, offering new hope for patients who might otherwise have limited treatment options for cervical cancer.
Recent real-world studies have further corroborated the presence of HER2 mutations in cervical cancer, reinforcing the need for targeted therapies in these patients. The NCCN guidelines’ inclusion of neratinib reflects the growing understanding of the role that HER2 mutations play in cervical cancer biology and the need to tailor treatments to genetic profiles, particularly for cervical cancer patients.
The Role of NCCN Guidelines
The National Comprehensive Cancer Network (NCCN) is a non-profit alliance of leading cancer centers dedicated to improving patient care through research, education, and collaboration. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) are widely recognized as the most comprehensive and frequently updated clinical resource for cancer treatment. These guidelines provide evidence-based, expert consensus recommendations to ensure healthcare providers have access to the best available treatment strategies for cervical cancer patients. By including neratinib in the guidelines, NCCN has recognized its potential as a valuable treatment option for patients.By including neratinib in the guidelines, NCCN has recognized its potential as a valuable treatment option for HER2-mutated cancer patients.
About Puma Biotechnology
Puma Biotechnology is a biopharmaceutical company focused on developing innovative therapies to improve cancer care. Neratinib, marketed under the brand name NERLYNX®, is one of the company’s key products. Approved by the U.S. FDA in 2017 for the extended adjuvant treatment of HER2-positive breast cancer, neratinib is also authorized in combination with capecitabine for the treatment of advanced or metastatic HER2-positive breast cancer. Additionally, the European Commission approved NERLYNX® for the extended adjuvant treatment of early-stage hormone receptor-positive, HER2-overexpressed/amplified breast cancer.
Puma Biotechnology continues to expand its portfolio with promising therapies, including alisertib, a small molecule inhibitor targeting aurora kinase A. Alisertib is currently undergoing clinical trials for the treatment of small cell lung cancer and breast cancer, demonstrating Puma’s ongoing commitment to advancing cancer treatments across multiple oncology indications.
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