Stage (next event)
Quarterly Sales (Approved)
February 19, 2021 (Est)
Catalyst Info & Data Links
TITLE: NERLYNX for HER2-positive breast cancer - Quarterly Sales (Approved)
ClinicalTrials.gov (NCT01808573): A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting (NALA)
WHAT IS THE CATALYST EVENT?
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
February 19, 2021 (Est)
Quarter's sales: $49.3M (Q3/2020)
See image below for quarter sales quarterly trend graph
2020 Revenue guidance: NOT PROVIDED by company
11-05-2020 Third Quarter 2020 Financial Results
08-06-2020 Second Quarter 2020 Financial Results
05-07-2020 First Quarter 2020 Financial Results
05-07-2020 Licensing Partner CANbridge Pharmaceuticals Receives Marketing Approval in Mainland China for NERLYNX® (neratinib) for Extended Adjuvant Treatment of Early Stage HER2-Positive Breast Cancer
09-04-2019 Licensing Partner Pint Pharma Receives Marketing Authorization for NERLYNX® (neratinib) for Extended Adjuvant Treatment of Early Stage Hormone Receptor Positive, HER2-Positive Breast Cancer
2016: Adaptive randomization of neratinib in early breast cancer. New England Journal of Medicine, 375(1), 11-22.
2017: Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet Oncology, 18(12), 1688-1700.
Mechanism of Action
MECHANISM OF ACTION
Neratinib is an intracellular kinase inhibitor that irreversibly binds to epidermal growth factor receptor (EGFR), HER2, and HER4. In vitro, neratinib reduces EGFR and HER2 autophosphorylation, downstream MAPK and AKT signaling pathways, and showed antitumor activity in EGFR and/or HER2 expressing carcinoma cell lines. Neratinib human metabolites M3, M6, M7 and M11 inhibited the activity of EGFR, HER2, and HER4 in vitro. In vivo, oral administration of neratinib inhibited tumor growth in mouse xenograft models with tumor cell lines expressing HER2 and EGFR.
Approximately 20 to 25 percent of breast cancer tumors over-express the HER2 protein. 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 returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.
Updated by HC
Prior Data (click to view full image)
Trial Design / Revenue (click to view full image)
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