Generic Therapy Launched for Metastatic NSCLC and Pancreatic Cancer

Mylan Pharmaceuticals has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Erlotinib Hydrochloride Tablets, 25 mg, 100 mg and 150 mg.

Mylan Pharmaceuticals has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Erlotinib Hydrochloride Tablets, 25 mg, 100 mg and 150 mg, and the product has been launched in the United States market. This product is a generic version of Genentech's Tarceva.

Erlotinib hydrochloride 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 1 prior chemotherapy regimen.

The safety and efficacy of erlotinib has not been established in patients with NSCLC whose tumors have other EGFR mutations. The therapy is also indicated as a first-line treatment for patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.

Erlotinib is not recommended for use in combination with other platinum-based chemotherapy.

Sales for erlotinib hydrochloride tablets, 25 mg, 100 mg and 150 mg in the United States were approximately $212 million for the 12 months ending March 31, 2019, according to IQVIA.

Reference

Mylan Expands Oncology Portfolio with Launch of Generic Tarceva® Tablets [news release]. Hertfordshire, England and Pittsburgh, PA; May 10, 2019: Mylan. http://investor.mylan.com/news-releases/news-release-details/mylan-expands-oncology-portfolio-launch-generic-tarcevar-tablets. Accessed May 10, 2019.