Teva Pharmaceutical Industries Ltd. announced the launch of a generic version of Tarceva®1 (erlotinib) tablets, 100 and 150 mg, in the U.S.
Erlotinib Tablets are a kinase inhibitor 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. Erlotinib Tablets are also indicated for first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer in combination with gemcitabine.
“The launch of generic Tarceva® tablets marks an important addition to our offering of oncology products,” said Brendan O’Grady, EVP and Head of North America Commercial.
Tarceva® tablets have annual sales of $202 million in the U.S., according to IQVIA data as of February 2019.
About Erlotinib Tablets
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.Limitations of use: Safety and efficacy of Erlotinib Tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations. Erlotinib Tablets are not recommended for use in combination with platinum-based chemotherapy.
Erlotinib Tablets in combination with gemcitabine are indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
