Puma’s Nerlynx included in NCCN guidelines for HER2-positive breast cancer

Puma Biotechnology announced that the National Comprehensive Cancer Network or NCCN, Clinical Practice Guidelines in Oncology for Breast Cancer were updated to include an addition involving neratinib NERLYNX . The updated NCCN Practice Guidelines for Breast Cancer include neratinib combinations as category 2B potential targeted therapies for patients with ER+/HER2- or ER-/HER2- metastatic breast cancer and activating mutations in the HER2 gene as detected by next generation sequencing of tumor tissue or ctDNA…" …Additionally, in its recent update, NCCN included dose escalation in the neratinib dosing schedule for recurrent unresectable or metastatic breast cancer. The neratinib dose escalation schedule was previously included in the 2022 NCCN Guidelines for Breast Cancer under preoperative/adjuvant therapy regimens as an approach to improve the tolerability of neratinib in the treatment of adjuvant HER2-positive breast cancer. This latest update aligns with the labeling supplement to the U.S. Prescribing Information approved by the U.S. Food and Drug Administration in June 2021, which incorporated the use of NERLYNX dose escalation as evaluated in the Phase II CONTROL study. 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 Breast 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 breast cancer."