Eli Lilly's new lung cancer therapy Portrazza has been approved in the EU as a first-line treatment for adults with a form of lung cancer.
The European Commission gave the go-ahead to Portrazza (necitumumab) - a new-generation epidermal growth factor receptor (EGFR) blocker - for use in combination with gemcitabine and cisplatin patients with advanced EGFR-positive squamous non-small cell lung cancer (NSCLC).
This form of lung cancer is particularly aggressive, with a five-year survival rate of less than 5% and has seen very few treatment advances in recent years.
Lilly's drug, which was first approved in the US in last November, is the first biologic licensed in the EU as a first-line treatment option for this indication, according to the company.
Portrazza was launched in December with a hefty price tag of $11,430 a month, attracting criticism from doctors who said the drug was considerably over-priced considering that it extends life expectancy by a matter of weeks.
The drug is to be used until disease progression - which generally occurs within six months - and so means the typical cost per patient will be around $65,000. In the pivotal SQUIRE trial, Portrazza extended survival to an average of 11.5 months versus 9.9 months for gemcitabine and cisplatin alone.
Last summer, ahead of the approval and launch of the drug, an editorial in the journal JAMA Oncology authored by physicians from Emory University and Georgia Institute of Technology suggested that a reasonable price for Portrazza would be $1,870 per month, less than one sixth of its US list price.
It remains to be seen whether the controversy surrounding Portrazza's price will hold back its penetration of the market given that doctors and healthcare payers are becoming increasingly vocal about drug pricing, but Lilly insists its pricing is fair.
Richard Gaynor, senior vice president of product development and medical affairs for Lilly Oncology, said: "Lung cancer is the leading cause of cancer death in the EU and there is a need for first-line treatment options."
The company has also introduced a discount programme in the US that will allow people on lower incomes to receive the drug at an out-of-pocket cost of no more than $25 per dose. It has not yet divulged pricing plans for Europe.
In the meantime, the approval rounds out Lilly's lung cancer portfolio, sitting alongside Alimta (pemetrexed) which is positioned as a first-line therapy for non-squamous NSCLC, and VEGFR2 antagonist Cyramza (ramucirumab) available as a second-line therapy for both squamous and non-squamous forms of the disease.
Analysts have predicted sales of around $500m a year for Portrazza - given its first-line positioning and fairly short treatment duration. However, it could still face competition if checkpoint inhibitors such as Bristol-Myers Squibb's Opdivo (nivolumab) and Merck & Co's Keytruda (pembrolizumab) migrate from second-line to first-line use.