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Association details:
| Biomarker: | HER-2 overexpression |
|---|---|
| Cancer: | Breast Cancer |
| Drug: | Nerlynx (neratinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Biomarker Analysis of the Phase III NALA Study of Neratinib + Capecitabine vs Lapatinib + Capecitabine in Patients with Previously Treated Metastatic Breast Cancer
Published date:
08/11/2021
Excerpt:
Patients whose tumors had higher HER2 protein expression (any method) derived an increased benefit from N+C versus L+C (IHC=3+, HR=0.64 [0.51-0.81]; H-score {greater than or equal to}240, HR=0.54 [0.41-0.72...
Secondary therapy:
capecitabine
DOI:
10.1158/1078-0432.CCR-21-1584
Trial ID:
Title:
Puma Biotechnology Licensing Partner Specialised Therapeutics Receives Marketing Approval in Malaysia for NERLYNX® (neratinib) for Extended Adjuvant Treatment of Early Stage HER2-Positive Breast Cancer
Excerpt:
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that its licensing partner Specialised Therapeutics Asia (STA) has received marketing approval of NERLYNX® (neratinib) in Malaysia from the Drug Control Agency (DCA), under Malaysia’s Ministry of Health (MOH). NERLYNX is indicated 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.
Source:
Title:
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)
Excerpt:
...Documented HER2 overexpression or gene-amplified tumor immunohistochemistry...
Trial ID:
