Another day and another approval in Europe for Sanofi, this time for its colorectal cancer drug Zaltrap.
The European Commission has granted marketing authorisation to Zaltrap (aflibercept) in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI chemotherapy), for patients with metastatic colorectal cancer (mCRC) who failed to respond to treatment with an oxaliplatin-containing regimen. Approval for the drug, which is partnered with Regeneron Pharmaceuticals, is based on data from the VELOUR Phase III trial which showed that adding Zaltrap to FOLFIRI significantly improved median survival from 12.06 months to 13.50 months.
The company quoted Eric Van Cutsem of the University Hospitals Leuven, Belgium and lead investigator of the VELOUR study, who said Zaltrap is "an important addition to the mCRC treatment landscape and helps to fill a critical treatment gap. “He added that it is "the first and only agent to demonstrate a statistical survival improvement in a Phase III trial in patients previously treated with an oxaliplatin-based regimen who are being treated with FOLFIRI".
In Europe, colorectal cancer is the most common cancer in both men and women and is the second leading cause of cancer death. In 2008, there were 436,000 new cases diagnosed and 212,000 deaths.
Pricing an issue
Zaltrap received approval from the US Food and Drug Administration in August 2012 after a priority review. However in November, Sanofi halved the list price of around $11,000 per patient per month after the Sloan-Kettering Cancer Center, one of the USA's most prominent cancer hospitals, sent a letter saying it would not use Zaltrap, claiming it was "outrageously expensive" and provided little added value to Roche's cheaper Avastin (bevacizumab), which cost half as much.
The Zaltrap approval comes a day after the European Commission gave the green light to Sanofi's diabetes drug Lyxumia (lixisenatide).