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Find Clinical Drug Pipeline Developments & Deals for Neratinib Maleate
Nerlynx (neratinib) is a kinase inhibitor that irreversibly binds to EGFR, HER2, and HER4. It reduces EGFR and HER2 autophosphorylation, downstream MAPK and AKT signaling pathways, and showed antitumor activity in EGFR and/or HER2 expressing carcinoma cell lines.
As a small molecule that can cross the blood brain barrier, Nerlynx (neratinib) potentially offers patients with HER2-positive metastatic breast cancer that has metastasized to the CNS a novel HER2 targeted treatment option.
NERLYNX® (neratinib) tablets, for oral use, is a kinase inhibitor indicated as a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
NERLYNX® (neratinib) tablets, for oral use, is a kinase inhibitor indicated as a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
The results suggest that the combination of Nerlynx (neratinib), fulvestrant, and trastuzumab together is promising for treating HR+ and HER2-mutated MBC with prior exposure to CDK4/6i across a range of HER2 mutations.
Efficacy results from the BTC cohort of 25 patients for Nerlynx (Neratinib) demonstrated an overall response rate (ORR) of 16%, 95% CI 4.5-36.1%), median progression free survival (PFS) of 2.8 months and overall survival (OS) of 5.4 months.
NERLYNX (Neratinib) is prescription medicine used alone to treat adults with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer and who have previously been treated with trastuzumab-based therapy.
Nerlynx (neratinib) is a potent irreversible tyrosine kinase inhibitor, or TKI, that blocks signal transduction through the epidermal growth factor receptors, or EGFRs, HER1, HER2 and HER4.
NERLYNX approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer.
The second tranche of $25 million may be drawn at a later date; if drawn down these proceeds would be used for general corporate purposes and to further support NERLYNX® commercial initiatives.
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