Buy Generic Tarceva (Erlotinib) Online.
Active substance: Erlotinib
Indian Brand: Erlocip / Erlonat
US Brand: Tarceva
Manufacturer: Cipla / Natco
Type of packaging: 30 tablets in pack
Delivery time: 7 – 16 days.
What is Erlotinib?
Erlotinib hydrochloride (trade name Tarceva) is a drug used to treat non-small cell lung cancer, pancreatic cancer and several other types of cancer. It is a reversible tyrosine kinase inhibitor, which acts on the epidermal growth factor receptor (EGFR). It is marketed in the United States by Genentech and OSI Pharmaceuticals and elsewhere by Natco & Cipla. In lung cancer, it extends life by an average of 3.3 months.
Mechanism of action.
Erlotinib is an EGFR inhibitor. The drug follows Iressa (gefitinib), which was the first drug of this type. Erlotinib specifically targets the epidermal growth factor receptor (EGFR) tyrosine kinase, which is highly expressed and occasionally mutated in various forms of cancer. It binds in a reversible fashion to the adenosine triphosphate (ATP) binding site of the receptor. For the signal to be transmitted, two EGFR molecules need to come together to form a homodimer. These then use the molecule of ATP to trans-phosphorylate each other on tyrosine residues, which generates phosphotyrosine residues, recruiting the phosphotyrosine-binding proteins to EGFR to assemble protein complexes that transduce signal cascades to the nucleus or activate other cellular biochemical processes. By inhibiting the ATP, formation of phosphotyrosine residues in EGFR is not possible and the signal cascades are not initiated.
Why is this medication prescribed?
Erlotinib is used to treat non-small cell lung cancer that has spread to nearby tissues or to other parts of the body in patients who have already been treated with at least one other chemotherapy medication and have not gotten better. Erlotinib is also used in combination with another medication (gemcitabine [Gemzar]) to treat pancreatic cancer that has spread to nearby tissues or to other parts of the body. Erlotinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.
On May 14, 2013, the U. S. Food and Drug Administration approved erlotinib (Tarceva, Astellas Pharma Inc.) for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) patients whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. This indication for erlotinib is being approved concurrently with the cobas EGFR Mutation Test, a companion diagnostic test for patient selection.
The approval was based on the results of a randomized, multicenter, open label trial comparing erlotinib (n=86) to platinum-based doublet chemotherapy (n=88) in patients with metastatic NSCLC whose tumors had EGFR exon 19 deletions or exon 21 (L858R) substitution mutations determined by a clinical trial assay (CTA). Eligible patients were randomly allocated (1:1) to receive erlotinib, 150 mg/day orally, or platinum-based doublet chemotherapy. Randomization was stratified by EGFR mutation (exon 19 deletion or exon 21 (L858R) substitution) and ECOG PS (0 vs. 1 vs. 2). Tumor samples from 134 patients were tested retrospectively by the cobas® EGFR Mutation Test.
The trial’s primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints included overall survival (OS) and objective response rate (ORR).
The median age of patients was 65 years. The majority of the patients were female (72%), Caucasian (99%), never-smokers (69%), and had adenocarcinoma histology (93%).
The median PFS was 10.4 months in the erlotinib arm and 5.2 months in the platinum-based chemotherapy arm [HR 0.34 (95% CI: 0.23, 0.49), p <0.001]. The median OS was 22.9 months in the erlotinib arm and 19.5 months in the platinum-based chemotherapy arm [HR 0.93 (95% CI: 0.64, 1.35), p=0.6482]. The ORR was 65% in the erlotinib arm and 16% in the platinum-based chemotherapy arm. The majority of the patients in the platinum-based chemotherapy arm (82%) subsequently received an EGFR tyrosine kinase inhibitor following investigator-determined disease progression. Analysis of PFS in the cobas EGFR Mutation Test positive patients was consistent with the primary analysis.
The most frequent (≥ 30%) adverse reactions of any grade in the erlotinib arm were rash, diarrhea, asthenia, cough, dyspnea and decreased appetite. The most frequent (≥ 5%) grade 3-4 adverse reactions in the erlotinib arm were rash and diarrhea.
The recommended daily dose of erlotinib for NSCLC is 150 mg taken orally at least one hour before or two hours after the ingestion of food. Treatment should continue until disease progression or unacceptable toxicity.
Full prescribing information is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021743s018lbl.pdf