US FDA approves new

The US Food and Drug Administration (FDA) has given a nod to a revolutionary drug that has shown promise against non-small cell cancer (NSCLC). Researchers that the “breakthrough” drug is effective that it can change the process of treatment of even deadliest of cancers and will take it to next level.

“The approval of this drug and a test to identify patients most likely to benefit has the potential to transform the way that lung cancer is treated,” said Dr Edward Garon, the study’s principal investigator and a researcher at University of California, Los Angeles’ Jonsson Comprehensive Cancer Centre.

He further added that the drug has shown promising results and has a long lasting effect. Such kind of responses were never seen previously especially in lung cancer. The “breakthrough” treatment will prevent cancer patients from toxicity of chemotherapy.

After seeing the long lasting effect of the drug over 500 patients back in October last year, the FDA claimed drug Keytruda (pembrolizumab)  to be “breakthrough therapy” for lung cancer and forwarded the application for quick approval under FDA’s accelerated approval programme that provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials..

In a three year clinical trial, researchers found that nearly 19 percent of people were examined with reduced tumor size while average response time for people who responded to the therapy exceeded one year, a breakthrough advance in this deadly disease.

While explaining the working of Keytruda Garon said that the drug targets PD-1 protein expressed by immune cells. PD-1 binds with other protein called PD-L1 and reduces attacking ability of immune system’s T cells. Thus cancer cells continue to grow. While Keytruda blocks this binding of PD-1 and PD-L1 and allows immune system to attack cancer cells.

In the trail, nearly 25 percent of patients had PD-L1 expression out of which 50 percent of the patients responded to the drug.

While talking of side effects, Keytruda can cause fatigue, breathing problems and decreased appetite.

It is first study that shows interaction of PD-1 and PD-L1 protein.

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