FDA grants priority review for Sanofi cancer drug
pharmafile | April 5, 2012 | News story | Research and Development, Sales and Marketing | Erbitux, FDA, Regeneron, Sanofi, Zaltrap, colorectal cancer, prostate cancer
The FDA has granted Sanofi and partner Regeneron priority review for their colorectal cancer drug Zaltrap.
Zaltrap (aflibercept) is seeking a licence to treat patients with metastatic colorectal cancer (mCRC), who have been previously treated with an oxaliplatin-containing regimen.
The drug, which will need to be infused, will be used in combination with irinotecan-fluoropyrimidine-based chemotherapy.
A priority review designation is given to drugs if the FDA believes it has the potential to provide a treatment where no adequate therapy exists, or can provide a significant improvement compared to treatments already on the market.
The target date for an FDA decision on the Zaltrap is 4 August, 2012. The filing was based on the Phase III VELOUR study in patients with metastatic colorectal cancer previously treated with an oxaliplatin-containing regimen.
This study showed the drug improved median overall survival by over one month compared to placebo (13.5 months versus 12.06) and median progression-free survival by over two months (6.9 months versus 4.67).
Debasish Roychowdhury, senior vice president and head of Sanofi Oncology, said: “Sanofi and Regeneron are committed to the continued development of Zaltrap and we are very pleased that the FDA has chosen to grant priority review to Zaltrap in metastatic colorectal cancer.
“We look forward to working closely with the FDA to potentially bring an important new option to patients with this difficult disease,” he added.
Current treatments for mCRC include Merck Serono’s Erbitux (cetuximab), Roche’s Avastin (bevacizumab) and Amgen’s Vectibix (panitumumab).
Erbitux brought in sales of €855 million ($1.1 billion) last year, with Roche’s Avastin taking home CHF5.3 billion, but this also includes its licences for breast, lung and brain cancers.
Bayer and Onyx’s colorectal cancer drug regorafenib is also being tested for mCRC, and recently showed that it increased overall survival for late-stage patients compared to Avastin.
Aflibercept is already approved in the US to the common eye disease wet age related macular oedema under the brand name Eylea.
This licence was granted to Regeneron and partner Bayer, and is separate from the deal with Regeneron and Sanofi.
Zaltrap fails in prostate cancer
Meanwhile, the firms separately announced that the drug has failed to meet its primary endpoint in a Phase III trial for prostate cancer.
The VENICE study was evaluating the addition of Zaltrap to a regimen of docetaxel and prednisone for the first-line treatment of metastatic androgen-independent prostate cancer.
The study did not meet its primary endpoint of increasing overall survival, but the firms said the drug’s safety profile was generally consistent with previous studies of Zaltrap in combination with docetaxel.
The companies are conducting a detailed analysis of the VENICE data, and full results will be presented at an upcoming medical meeting.
Ben Adams
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