Sanofi and partner Regeneron Pharmaceuticals will be celebrating news that their oncology drug Zaltrap has been approved for use in the US in patients with colon cancer.
Following an accelerated review of the drug's application, the US Food and Drug Administration has given the go-ahead for Zaltrap (ziv-aflibercept) injection in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI), for the treatment of patients with metastatic colorectal cancer (mCRC) which has failed to respond to treatment with an oxaliplatin-containing regimen.
The approval is good news for patients eligible for treatment as colorectal cancer is one of the deadliest cancers - killing more than half a million people every year - and options are limited for those who are resistant to or whose disease has progressed after receiving an oxaliplatin-based therapy.
The green light for Zaltrap - a novel angiogenesis inhibitor - came on the back of data from the Phase III multinational VELOUR trial, which compared FOLFIRI in combination with the drug against FOLFIRI and a placebo and met its primary endpoint of demonstrating an overall survival benefit.
Data from the trial showed that in patients previously given an oxaliplatin-containing regimen, adding Zaltrap to FOLFIRI significantly improved median survival from 12.06 months to 13.50 months, an 18% relative risk reduction, the firms said.
Zaltrap should be available in the US in the third quarter of this year, according to Sanofi, where it will compete for market share with Roche's Avastin (bevacizumab) and Bristol-Myers Squibb's Erbitux (cetuximab).
Marketing applications for the drug are also under review by regulators in Europe and elsewhere around the globe.