Sanofi and Regeneron have won approval in the US for Zaltrap, their new drug for patients with metastatic colorectal cancer that has progressed despite treatment with oxaliplatin-based chemotherapy.
This is the first approval worldwide for Zaltrap (ziv-aflibercept), which has the same active ingredient in Regeneron's age-related macular degeneration (AMD) drug Eylea (aflibercept) but has been given a different nomenclature to differentiate the two drugs. Aflibercept is an angiogenesis inhibitor that inhibits the blood supply to tumours.
The FDA approved Zaltrap for use alongside the widely-used FOLFIRI regimen of 5-fluorouracil, leucovorin and irinotecan, based on the results of the phase III VELOUR trial which showed the combination boosted survival compared to FOLFIRI alone.
Overall survival was 13.5 months for the Zaltrap group, compared to 12.05 months with FOLFIRI and placebo, while progression-free survival (PFS) came in at 6.9 months versus 4.7 months in the comparator group. Both results were statistically significant, the FDA said in a statement.
Zaltrap is not expected to be a big-selling product in the second-line therapy setting in colorectal cancer - particularly as it will have to compete with blockbusters such as Roche's Avastin (bevacizumab) and Bristol-Myers Squibb's Erbitux (cetuximab) - and analysts have predicted it could achieve global peak sales in the $150m to $350m range in this indication.
The drug is currently under review by the EMA in Europe and could be given a green light there before the end of the year.
Meanwhile, additional studies are ongoing to see if Zaltrap could be of use as a first-line therapy in colorectal cancer and, if results are positive, the product could in time reach blockbuster sales levels according to market analysis firm Decision Resources.
Approval is an important development for Sanofi, which set up a dedicated oncology business unit in 2008 but suffered a setback when flagship cancer drug iniparib failed in a phase III trial in metastatic triple-negative breast cancer. And Zaltrap itself failed to show efficacy in a late-stage trial involving men with advanced prostate cancer.
Sanofi has said it plans to launch the product in the US in the third quarter of 2012, and will share profits on sales of Zaltrap with Regeneron, once the latter reimburses Sanofi for development costs associated with the programme.