Regulatory Focus™ > News Articles > New Colorectal Cancer Therapy Approved by FDA

New Colorectal Cancer Therapy Approved by FDA

Posted 03 August 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has approved sanofi and Regeneron Pharmaceuticals' Zaltrap (ziv-aflibercept) for the treatment of colorectal cancer in combination with FOLFIRI (folinic acid, fluorouracil and irinotecan).

The drug had mixed results in clinical trials, with the two companies revealing in April 2012 that it was ineffective at treating prostate cancer-a target since withdrawn.

Sanofi and Regeneron instead decided to focus solely on the drug's colorectal cancer application, which was granted priority review status by FDA's Office of Hematology and Oncology Products (OHOP) in April 2012.

In a 3 August 2012 statement announcing the drug's approval, OHOP Director Richard Pazdur, MD, said the drug was a good example of the benefits of combination therapies. "This approval demonstrates the benefits of adding a biological agent, Zaltrap, to a commonly used chemotherapy drug regimen, FOLFIRI," Pazdur said.

The treatment was recognized by FDA as having an improved median survival time, delayed tumor progression and an improved response rate, all of which contributed to FDA's approval decision.

Colorectal cancer is the fourth most common type of cancer, corresponding  to its position as the fourth leading cause of death in the US. The cancer is particularly deadly, with more than 35% of patients expected to succumb from it.

Patients only treated with FOLFIRI lived an average of 12 months, with those treated with Zaltrap as well as FOLFIRI lived an average of 13.5 months. Zaltrap patients also experienced 6.9 months of progression-free survival-a 2.2 month increase over FOLFIRI alone.

Neither sanofi nor Regeneron had released a statement at the time of this article's publication.

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