Biopharmaceutical company Puma Biotechnology (NASDAQ: PBYI) announced on Monday that its drug NERLYNX (neratinib) has been included in the updated National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Cervical Cancer.
Neratinib has been added as a treatment option for second-line or subsequent therapy in patients with recurrent or metastatic cervical cancer with HER2 mutations, with a Category 2A designation, indicating it is "useful in certain circumstances."
This addition is based on the results of the Phase II SUMMIT trial, which demonstrated the efficacy of neratinib in patients with HER2-mutated cervical cancer who had no curative treatment options. HER2 mutations are found in up to 9% of cervical cancer cases and are associated with poor prognosis.
NERLYNX was previously approved for the treatment of HER2-overexpressed/amplified breast cancer and has since expanded to include metastatic HER2-positive breast cancer in combination with capecitabine. Puma's ongoing research includes the development of additional treatments for small cell lung cancer and breast cancer, such as alisertib, a selective inhibitor of aurora kinase A.
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