Erlotinib Tablets

Generic name: erlotinib hydrochloride
Dosage form: tablet, film coated
Drug class:EGFR inhibitors

Medically reviewed by Drugs.com. Last updated on Jul 1, 2021.

INDICATIONS AND USAGE

Non-Small Cell Lung Cancer (NSCLC)

Erlotinib Tablets are indicated for:

• The 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 receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen [see Clinical Studies (14.1, 14.3)].

Limitations of use:

• Safety and efficacy of Erlotinib Tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations [see Clinical Studies (14.1, 14.2)].
• Erlotinib Tablets are not recommended for use in combination with platinum-based chemotherapy [see Clinical Studies (14.4)].

Pancreatic Cancer

Erlotinib tablet in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer [see Clinical Studies (14.5)].

DOSAGE AND ADMINISTRATION

Selection of Patients with Metastatic NSCLC

Select patients for the treatment of metastatic NSCLC with Erlotinib Tablets based on the presence of EGFR exon 19 deletions or exon 21 (L858R) substitution mutations in tumor or plasma specimens [See Clinical Studies (14.1, 14.2)]. If these mutations are not detected in a plasma specimen, test tumor tissue if available. Information on FDA-approved tests for the detection of EGFR mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics.

Recommended Dose – NSCLC

The recommended da...