PBYI

Neratinib

Metastatic Cervical Cancers

Stage (next event)

Expected Date

Phase 2 (Pre-NDA meeting with the FDA)

H1 2021

Catalyst Info & Data Links

TITLE: Neratinib for Metastatic Cervical Cancers - Pre-NDA meeting with the FDA

  • ClinicalTrials.gov (NCT01953926): Neratinib HER Mutation Basket Study (SUMMIT)


WHAT IS THE CATALYST EVENT?

  • Pre-NDA meeting with the FDA


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


PRIOR DATA/EVENTS

PRESS RELEASE

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

  • ~ 13,800 women in the United States will be diagnosed with invasive cervical cancer. 

  • Hispanic women and African American women are most likely to get the disease. 

  • It is estimated that 4,290 deaths from the disease will occur this year. Similar to the incidence rates, the death rate dropped by around 50% since the mid-1970s, partly because the increase in screening resulted in earlier detection of cervical cancer.

  • Learn more at Cancer.net

Updated by HC

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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