PBYI

NERLYNX

Metastatic HER2-positive breast cancer

Stage (next event)

Expected Date

Quarterly Sales (Approved)

February 19, 2021 (Est)

Catalyst Info & Data Links

TITLE: NERLYNX for HER2-positive breast cancer - Quarterly Sales (Approved)

  • FDA Label

  • 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?

  • Quarterly Sales


WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?

  • February 19, 2021 (Est)


PRIOR DATA/EVENTS

PRESS RELEASE

Quarter's sales: $49.3M (Q3/2020)

See image below for quarter sales quarterly trend graph

2020 Revenue guidance: NOT PROVIDED by company

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.

MARKET

  • 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)

Chart

Trial Design / Revenue (click to view full image)

Chart

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