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Sanofi, Regeneron Say FDA Grants Priority Review To Zaltrap In Cancer

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Sanofi (SNY: Quote) and Regeneron Pharmaceuticals, Inc. (REGN) on Thursday said that the Biologics License Application for the investigational agent Zaltrap (aflibercept) concentrate for solution has been granted priority review by the Food and Drug Administration.

Zaltrap is proposed for infusion in combination with the irinotecan-fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer, or mCRC, previously treated with an oxaliplatin-containing regimen.

A priority review designation is given to drugs if preliminary estimates indicate that the drug product, if approved, has the potential to provide a treatment where no adequate therapy exists or a significant improvement compared to products already available on the market.

Under priority review, the target date for an FDA decision on the Zaltrap BLA is August 4. The filing was based on the Phase III Velour study in patients with metastatic colorectal cancer previously treated with an oxaliplatin-containing regimen.

Separately, the companies announced the results from the Phase III VENICE trial 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 the pre-specified criterion of improvement in overall survival. The 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.

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by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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After ending the previous session mostly higher, stocks may see some further upside in early trading on Wednesday. The major index futures are currently pointing to a modestly higher open for the markets, with the Dow futures up by 17 points. The Bank of Spain on Wednesday boosted its growth projections for Spain this year and the next after the economy grew at a faster rate in the second quarter. In its monthly economic bulletin, the bank raised the growth forecast for this year to 1.3 percent from the 1.2 percent seen previously. The projection for the next year was lifted to 2 percent from 1.7 percent. Bank of England policymakers unanimously decided to maintain the key interest rate and quantitative easing at the meeting held on July 9 and 10, but signaled the possibility of a rate hike late this year as growth became more established.
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