Puma Biotechnology, Inc., a biopharmaceutical company, announced that the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Cervical Cancer were updated to include an addition involving neratinib (NERLYNX®).
The updated NCCN Practice Guidelines for Cervical Cancer include neratinib monotherapy for use as second-line or subsequent therapy for recurrent or metastatic disease as an option for patients with HER2-mutated tumors with a designation of Category 2A. The NCCN Guidelines Category of Preference is designated as “useful in certain circumstances” as a treatment option for patients with HER2-mutated tumors.
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This addition was based on results from the Phase II SUMMIT trial (NCT01953926), which enrolled a cohort of patients who were required to have histologically confirmed recurrent/metastatic cervical cancer for which no curative treatment existed, along with documented evidence of a somatic, activating HER2 mutation (Friedman CF, D’Souza A, Bello Roufai D, et al. Targeting HER2-mutant metastatic cervical cancer with neratinib: Final results from the Phase II SUMMIT basket trial. Gynecol Oncol. 2024;181:162-169. doi: 10.1016/j.ygyno.2023.12.004).
Alan H. Auerbach, Chief Executive Officer and President of Puma, said, “We are pleased with the additional inclusion of neratinib in the NCCN Guidelines for Cervical Cancer for patients with HER2 activating mutations. Physicians use the NCCN Guidelines as the standard resource for determining the best course of treatment for patients. We believe the updated NCCN guidelines will increase awareness, which will help assist patients, their caregivers and their healthcare providers in making informed decisions while treating this significant unmet need in advanced cervical cancer.”
Source: Businesswire