Policy & Regulation
Puma biotechnology's Nerlynx Included in Two NCCN Clinical Practice Guideline Updates for the Treatment of Breast Cancer
14 January 2022 - - The National Comprehensive Cancer Network 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), US-based biopharmaceutical company Puma biotechnology, Inc. (NASDAQ: PBYI) said.

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 US Prescribing Information approved by the US Food and Drug Administration in June 2021, which incorporated the use of Nerlynx dose escalation as evaluated in the Phase II CONTROL study.

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.

The National Comprehensive Cancer Network (NCCN) is a not-for-profit alliance of leading cancer centers devoted to patient care, research, and education.

NCCN is dedicated to improving and facilitating quality, effective, efficient, and accessible cancer care so patients can live better lives.

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) provide transparent, evidence-based, expert consensus recommendations for cancer treatment, prevention, and supportive services; they are the recognized standard for clinical direction and policy in cancer management and the most thorough and frequently updated clinical practice guidelines available in any area of medicine.

The NCCN Guidelines for Patients provide expert cancer treatment information to inform and empower patients and caregivers, through support from the NCCN Foundation.

NCCN also advances continuing education, global initiatives, policy, and research collaboration and publication in oncology.

Puma biotechnology is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care.

Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357.

Neratinib, oral was approved by the US Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as Nerlynx (neratinib) tablets.

In February 2020, Nerlynx was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.

Nerlynx was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early-stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy.
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