Puma Biotechnology’s NERLYNX Included in Two Important NCCN Clinical Practice Guideline Updates for the Treatment of Breast Cancer

Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, announced that the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for the treatment of breast cancer have been updated for 2022 and include two important changes involving neratinib (NERLYNX).

The first update added NERLYNX to the body of the guidelines for the treatment of adjuvant HER2-positive Breast Cancer (BINV-L) under the heading Useful in Certain Circumstances, with a recommendation for considering extended adjuvant neratinib for patients with HR-positive, HER2-positive disease with a perceived high risk of recurrence.

The second update involved the inclusion of dose escalation as an approach to improve the tolerability of neratinib in the treatment of adjuvant HER2-positive Breast Cancer (BINV-L). This 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.

Joyce O’Shaughnessy, M.D., Baylor University Medical Center, Texas Oncology, US Oncology, Dallas Texas, said, “Oncologists should be aware of an important recent update to the NCCN guidelines that now include adjuvant neratinib to be used in certain circumstances, i.e., high-risk HR+, HER2+ early-stage breast cancer patients. These high-risk patients need access to every available treatment option proven to decrease their risk of recurrence, and the new NCCN guidelines update supports neratinib in this context.”

Alan H. Auerbach, Chief Executive Officer and President of Puma, added, “The NCCN guidelines are utilized by many institutions, practices and clinicians who treat breast cancer patients. These updates help to increase the awareness of neratinib within the guidelines and should further support neratinib as an appropriate option to reduce the risk of recurrence for patients battling HER2-positive breast cancer.”

About HER2-Positive Breast Cancer

Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.