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Generic Name: Erlotinib Hydrochloride Tablet
Active Ingredient: Erlotinib Hydrochloride
Dosage Form: Film-coated Tablet
Strengths: 25 mg / 100 mg / 150 mg (customizable)
Therapeutic Class: Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI)
ATC Code: L01EB02
Erlotinib Hydrochloride Tablet is an orally administered first-generation EGFR tyrosine kinase inhibitor (EGFR-TKI) used primarily for the treatment of EGFR mutation-positive non-small cell lung cancer (NSCLC). It selectively inhibits EGFR signaling pathways involved in tumor cell proliferation, survival, angiogenesis, and metastasis. Erlotinib is also approved in combination with gemcitabine for selected patients with advanced pancreatic cancer.
Erlotinib competitively binds to the ATP-binding site of the intracellular EGFR tyrosine kinase domain, preventing receptor autophosphorylation and downstream signaling through pathways including:
RAS/RAF/MEK/ERK pathway
PI3K/AKT/mTOR pathway
JAK/STAT pathway
By blocking these signaling cascades, Erlotinib suppresses tumor cell proliferation, promotes apoptosis, and inhibits angiogenesis.
The drug demonstrates higher affinity toward tumors harboring activating EGFR mutations, particularly:
Exon 19 deletion
Exon 21 L858R substitution mutation
These mutations are the primary predictive biomarkers for clinical response to Erlotinib.
Erlotinib Hydrochloride Tablet is indicated for:
First-line treatment
Maintenance therapy
Subsequent treatment following chemotherapy
Patients with confirmed EGFR exon 19 deletion or exon 21 (L858R) mutations
Used in combination with gemcitabine for:
Locally advanced pancreatic cancer
Unresectable pancreatic cancer
Metastatic pancreatic adenocarcinoma
Proven efficacy in EGFR-mutated NSCLC
Oral once-daily administration
Well-established clinical safety profile
Global regulatory approvals across multiple markets
Widely recognized reference therapy among first-generation EGFR-TKIs
| Parameter | Description |
|---|---|
| Drug Class | EGFR Tyrosine Kinase Inhibitor |
| Generation | First-generation EGFR-TKI |
| Administration | Oral |
| Protein Binding | Approximately 93% |
| Peak Plasma Time (Tmax) | Approximately 4 hours |
| Bioavailability | Approximately 60% fasting; increased with food |
Food significantly increases Erlotinib exposure; therefore, administration on an empty stomach is recommended according to prescribing information.
Erlotinib has been extensively evaluated in multiple international clinical studies and remains an established targeted therapy for:
EGFR-mutated metastatic NSCLC
Advanced pancreatic cancer (combination therapy)
Although later-generation EGFR inhibitors such as osimertinib have become preferred first-line options in many guidelines, Erlotinib continues to play an important role in numerous healthcare systems due to its clinical evidence, availability, and cost-effectiveness.
| Item | Information |
|---|---|
| API | Erlotinib Hydrochloride |
| Dosage Form | Film-coated Tablet |
| Strength | 25 mg / 100 mg / 150 mg |
| Route | Oral |
| Packaging | Customized |
| Shelf Life | According to registration requirements |
| Storage | Store below recommended temperature in original package |
Erlotinib was originally developed under the brand name Tarceva and has received regulatory approvals in numerous countries and regions worldwide.
Depending on market requirements, product dossiers may support registration through:
CTD/eCTD format
Country-specific regulatory submissions
Technology transfer projects
Licensing and distribution partnerships
Loncom Pharma provides integrated pharmaceutical solutions including:
Finished Dosage Form (FDF) supply
API manufacturing
CDMO services
Technology transfer
Global regulatory support
International market cooperation
Our manufacturing facilities operate under internationally recognized quality systems to support registration and commercialization in global markets.
Erlotinib is primarily used to treat patients with EGFR mutation-positive non-small cell lung cancer and, in combination with gemcitabine, certain patients with advanced pancreatic cancer.
It blocks the EGFR tyrosine kinase signaling pathway, inhibiting cancer cell growth and proliferation by preventing receptor activation.
Yes. Patients should undergo molecular testing to confirm eligible EGFR mutations before initiating Erlotinib treatment for NSCLC, as clinical benefit is closely associated with specific activating mutations.
Commercial strengths typically include 25 mg, 100 mg, and 150 mg, depending on regulatory approvals and market requirements.
Erlotinib hydrochloride tablet is a medication used in the treatment of certain types of cancer, particularly non-small cell lung cancer (NSCLC) and pancreatic cancer. It is a targeted therapy that belongs to a class of drugs known as epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. Erlotinib is designed to block specific proteins that play a role in the growth and spread of cancer cells.
Only confirmed
At present, the only GER1/EGFR Tyrosine kinase inhibitor proved to have survival advantages for advanced non-small cell lung cancer. It is effective for all types of non-small cell lung cancer patients.
More clinical data support
The number of clinical trials was twice that of Gefitinib. In first-line treatment of advanced NSCLC patients, Erlotinib has certain advantages over Gefitinib. There are relatively few frontline studies on icotinib hydrochloride.
Higher control rate
Compared with Gefitinib, the control rate of Chinese patients with advanced NSCLC receiving Erlotinib (first or second line) is higher, and the PFS and OS are longer.
Short half-life
Drugs metabolize quickly, do not cause drug accumulation, have good tolerance, and can improve quality of life.
