Sanofi’s colorectal cancer drug gains FDA approval
pharmafile | August 6, 2012 | News story | Sales and Marketing | FDA, Sanofi, Zaltrap, colorectal cancer
The FDA has approved Sanofi and Regeneron’s new oncology drug Zaltrap for aggressive forms of colorectal cancer.
Zaltrap (ziv-aflibercept), in combination with chemotherapy, is now approved in patients with metastatic colorectal whose tumours have progressed after an oxaliplatin-containing chemotherapy regimen.
Industry analysts say they expect Zaltrap to have peak annual sales of around $300 million to $400 million.
But this is far below the blockbuster sales that Roche’s Avastin and BMS/Merck Serono’s Erbitux are making for the same indication.
Avastin, which has a number of licences including colorectal cancer and renal cell carcinoma, also works as an anti-VEGF inhibitor and is a long-established drug amongst oncologists.
BMS/Merck Serono’s Erbitux works in a different way by targeting the EGFR mutation, and has a licence to treat head and necks cancers – it is also seeking a new European licence for EGFR-positive lung cancer.
But Zaltrap looks like it will not be adding to its new colorectal cancer licence as it has failed in three extra studies – for prostate cancer, lung cancer and pancreatic cancer.
Being late to the market and having no other licences is the primary reason why analysts do not see the drug as a major seller.
The FDA approval is based on a recent Phase III that showed progression-free survival for patients receiving Zaltrap plus chemotherapy agent Folfiri was 6.9 months compared with 4.7 months for those receiving Folfiri plus placebo.
But the US regulator has approved the drug with a ‘Boxed Warning’, as the drug can cause severe and sometimes fatal bleeding, including gastrointestinal bleeding, and the development of holes in the gastrointestinal tract – a common trait among angiogenesis inhibitors.
Sanofi said that marketing applications for Zaltrap are also under review by the European Medicines Agency and other regulatory agencies across the world.
Debasish Roychowdhury, senior VP and head of Sanofi oncology, said: “Colorectal cancer is one of the deadliest cancers and is responsible for more than half a million deaths globally each year.
“Sanofi looks forward to making Zaltrap available as soon as possible to patients with metastatic colorectal cancer previously treated with an oxaliplatin-containing regimen.”
Sanofi’s partner Regeneron has chalked up another regulatory success after its wet AMD drug Eylea (aflibercept), made in conjunction with Bayer, was approved in the US last year.
Zaltrap is chemically similar to Eylea, as they both work as anti-VEGF drugs, but Zaltrap has been tweaked in order to target VEGF mutations, whereas Eylea works as a VEGF eye trap.
Filling the Plavix hole
It is also good news for Sanofi, as sales from Zaltrap can go some way to plugging the hole left by its anticoagulant Plavix, which lost US patent in May and has succumbed to generic erosion in Europe.
Sanofi will not be able to rely on Zaltrap alone, and will need further pipeline drugs to make up the $9 billion in revenues Plavix brought in.
Ben Adams
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