FDA Gives Green Signal to Pfizer’s INYLTA

FDA Gives Green Signal to Pfizer’s INYLTAAs per reports, it has been revealed that the Food and Drug Administration (FDA) has given a green signal to Pfizer for its new oral treatment INLYTA. The oral drug is meant for patients who have been suffering from advanced Renal Cell Carcinoma (RCC).

The FDA said that Pfizer’s drug should act as second option for the patients who have not been benefitted from previous drug treatments. Pfizer Oncology Business Unit President, Garry Nicholson, said that the drug has better survival rate than Sorafenib which is generally given for the treatment of RCC.

In its phase three trial, it was revealed that INLYTA could provide cancer progression free survival for 6.7 months and sorafenib provides 4.7 months. This acted as great boost for the company to get permission from the FDA.

Nicholson informed that INYLTA is an oral therapy which is meant to treat specific vascular endothelial growth factor receptors. The drug is also said to influence tumor growth, vascular angiogenesis and cancer.

FDA’s Cancer Drug Director, Dr. Richard Pazdur said, “This is the seventh drug that has been approved for the treatment of metastatic or advanced kidney cell cancer since 2005”. But Mace Rothenberg, the Medical Affairs Senior Vice President of Pfizer, said that their drug is the first ever targeted therapy that has been approved in the US for advanced RCC patients.

The market for kidney drugs is steadily growing in the US and the majority of drug giants are targeting on developing drugs for Renal Cell Carcinoma. As per the National Cancer Institute, 61, 000 people in the US were diagnosed with RCC in 2011.

In this scenario, the development of effective drugs is a necessity as only 11% people diagnosed with RCC are able to survive for five or more years.