New Drug R&D

Erlotinib Hydrochloride Tablets

Product Name: Erlotinib Hydrochloride Tablets
Dosage Forms: Tablet
Strengths: 2 mg, 100 mg, 150 mg
Mechanism of Action:
Epidermal growth factor receptor (EGFR) is expressed on the cell surface of both normal and cancer cells. In some tumor cells signaling through this receptor plays a role in tumor cell survival and proliferation irrespective of EGFR mutation status. Erlotinib reversibly inhibits the kinase activity of EGFR, preventing autophosphorylation of tyrosine residues associated with the receptor and thereby inhibiting further downstream signaling. Erlotinib binding affinity for EGFR exon 19 deletion or exon 21 (L858R) mutations is higher than its affinity for the wild type receptor.
Indications:
It is indicated for:
• First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. 
• Maintenance treatment of patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. 
• Treatment of locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. 
• First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. 
Processing Number: CXHS1400111, CYHS1400375, CYHS1400376, CYHS1400377
Status: Has gotten the clinical trial permission (2016L01699, 2016L01638, 2016L01629, 2016L01637) in January, 2016.
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