15 May 2019 - - Israel-based drugmaker Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) (TASE: TEVA) has launched of a generic version of Tarceva1 (erlotinib) tablets, 100 and 150 mg, in the US, the company said.

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 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.

With nearly 500 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the US.

Currently, one in eight generic prescriptions dispensed in the US is filled with a Teva generic product.

Tarceva tablets have annual sales of USD 202m in the US, according to IQVIA data as of February 2019.

Erlotinib Tablets are indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor 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.