Generic Therapy Launched for Metastatic NSCLC and Pancreatic Cancer

Article

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.

Related Videos
Atopic dermatitis on a patient's hand -- Image credit: Ольга Тернавская | stock.adobe.com
cropped view of man performing chest compression on dummy during cpr training class - Image credit: LIGHTFIELD STUDIOS | stock.adobe.com
Medicine law concept. Judges gavel with pills | Image Credit: Iren Moroz - stock.adobe.com
Image credit: New Africa | stock.adobe.com
biosimilar word or concept represented by wooden letter tiles on a wooden table with glasses and a book | Image Credit: lexiconimages - stock.adobe.com
Image credit: alicja neumiler | stock.adobe.com
Laboratory test tubes and solution with stethoscope background | Image Credit: Shutter2U - stock.adobe.com
Image Credit: Pixel-Shot | stock.adobe.com
© 2024 MJH Life Sciences

All rights reserved.