FDA Approves New Treatment for Lung Cancer

“Our growing understanding of underlying molecular pathways and how our immune system interacts with cancer is leading to important advances in medicine”, said Richard Pazdur, director of the office of hematology and oncology products in the FDA’s Centre for Drug Evaluation and Research.

The drug was approved in 2014 for the treatment of patients with a diagnosis of advanced melanoma after patients had received treatment with an immunotherapy known as ipilimumab.

As such, Keytruda (pembrolizumab) has been cleared under the FDA’s accelerated approvals process for use with a companion diagnostic – the PD-L1 IHC 22C3 pharmDx test – to determine which NSCLC patients are eligible for treatment. “By aiding the selection of Keytruda therapy, our new PD-L1 testing service will deliver diagnostic insight to potentially help more patients fight back against the most prevalent form of lung cancer”. “For people battling this deadly disease, this approach provides real hope of long-lasting responses while avoiding the toxicities of typical chemotherapy”, Garon noted.

In the three-year clinical trial, the overall response rate (the percentage of people in whom tumours were substantially reduced in size) was 19 percent.

“The quality and duration of disease response that was seen in the trial had previously been extremely rare in lung cancer”.

Keytruda is already proved to have extended the lives of people with advanced melanoma, with its antibody that targets the protein PD-1, which is expressed by immune cells.

It’s the first time a study has validated that the level of PD-L1 expression is closely tied with clinical outcomes. “And of those patients who receive a response, about 80% of those patients will have a long term response”.

They have slightly different labelling in lung cancer. The growth can spread beyond the lung into other parts of the body. Usually in these cases it’s due to a combination of genetic factors or exposure to toxins like air pollution or asbestos. Now, News Radio 1200 WOAI reports Keytruda has been given “fast track” approval by the FDA for use in treating lung cancer, the leading cause of cancer deaths in the United States.

Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancers.

That means the treatment takes place without chemotherapy. It is the most common type of cancer in men and women, a nd it results in the most deaths worldwide at 1.56 million annually as of 2012.