LabCorp to Offer New PD-L1 Test for Bristol-Myers Squibb’s OPDIVO

“We are proud to announce the recent FDA approval of OPDIVO based upon overall survival in an expanded indication for all appropriate patients with previously treated metastatic non-small cell lung cancer”, said Michael Giordano, senior vice president and head of Development, Oncology, at Bristol-Myers Squibb.

Lung cancer consists of a far larger sized individual people compared to tumor, by having NSCLC auditing for about 90 % of most incidents, that is viewed as more luxury choose for the most recent remedies like Opdivo which help to your immune system dispute the disorder.

“Non-small cell lung cancer is a hard to treat disease with high mortality, and patients with squamous and non-squamous NSCLC often respond differently to treatment”, said Dr Roy Herbst, Chief of Medical Oncology, Yale Cancer Centre and Smilow Cancer Hospital at Yale-New Haven.

In regards to the specific test and its results, Quest Diagnostics general manager Christopher Fikry, MD, comments, “Lung cancer is the leading cause of cancer-related deaths, yet has traditionally been very hard to combat with conventional therapies”.

In the U.S., the PD-1 checkpoint inhibitor was first approved in December past year as a second-line treatment for advanced melanoma, followed by a green light in March in the squamous NSCLC setting.

Those treated with nivolumab lived an average of 12.2 months compared with 9.4 months in those treated with docetaxel.

Opdivo was previously approved for the treatment of advanced melanoma by the FDA in last December. These severe immune-mediated side effects involve healthy organs, including the lung, colon, liver, kidneys, hormone-producing glands and the brain. It also received priority review status, which is granted to drugs that, at the time the application was submitted, have the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition. That FDA green light came in February, several months ahead of its PDUFA date.

The drug’s approval for expanded use comes shortly after Keytruda (pembrolizumab), a similar drug manufactured by Merck that was granted accelerated approval for treating NSCLC specifically for patients whose tumors expressed PD-L1. The PD-L1 IHC 28-8 pharmDx test is marketed by Dako North America Inc.in Carpinteria, California.