Merck KGaA has hit another obstacle on its path to expanding Erbitux sales. The German drugmaker pulled its marketing application for a non-small cell lung cancer use in Europe--for the second time.
Initially, Merck had asked the European Medicines Agency to bless Erbitux for all patients with metastatic non-small cell lung cancer. EMA said no go. So, Merck refiled for use in NSCLC patients whose cancers tested positive for EGFR overexpression. That change cut the potential patient population by three-fourths, Reuters notes.
Now, Merck has backed away from that smaller group. "The decision to withdraw the applicaiton was based on feedback from European regulatory authorities, indicating that further data would be required," the company said in a statement. Erbitux is Merck's second-best selling drug with more than $1 billion in 2011 sales.
The move isn't completely unexpected; as the news service points out, a Merck executive earlier this year pegged Erbitux's chances for the new approval at less than 50%. But it's yet another setback for Merck's development efforts, both with Erbitux itself and with other experimental treatments. The company recently gave up on Erbitux in gastric cancer, and it backed off a bid for adjuvant treatment of colon cancer.
- get the statement from Merck
- see the Reuters news
Special Report: Erbitux--Top 10 Best-selling Cancer Drugs in 2011
Erbitux fails another trial, threatening Merck's hoped-for expansion
Merck KGaA tries again on Erbitux for lung cancer
Can targeted drugs save Big Pharma?