FDA expands Opdivo use for some NSCLC patients
SILVER SPRING, Md. — The Food and Drug Administration on Friday approved Bristol-Myers Squibb’s Opdivo (nivolumab) as a treatment for advanced lung cancer.
The drug can now be used on patients whose non-small cell lung cancer metastasized while undergoing platinum-based chemotherapy or after. The drug had been approved earlier this year for a different type of non-small cell lung cancer.
Opdivo woks by targeting proteins (PD-1/PD-L1) that are found in some cancer cells, potentially boosting the immune system’s ability to fight the cancer.
“There is still a lot to learn about the PD-1/PD-L1 pathway and its effects in lung cancer, as well as other tumor types,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “While Opdivo showed an overall survival benefit in certain non-small cell lung cancer patients, it appears that higher expression of PD-L1 in a patient’s tumor predicts those most likely to benefit.”
Along with the new use for the drug, the FDA also approved a test to detect PD-L1 levels in order to help physicians find patients who would benefit the most from Opdivo.
QS/1 gains EMV certification from Heartland Payment Systems
SPARTANBURG, S.C. — Some QS/1 software users can now process payments from customers with EMV chip-embedded cards. The company announced Friday that it had received certification to process Europay, MasterCard and Visa credit card purchases from Heartland Payment Systems.
“The EMV chip cards are the next step in helping protect consumers from credit card fraud,” said Sonny Anderson, QS/1’s vice president of Systems and Technology. “The certification from Heartland means our customers are protected from the liability shift included in the EMV standard.”
On Oct. 1, the financial liability for a counterfeit chip-enabled card being used at a terminal that only accepts cards with a magnetic swipe strip transferred to the non-EMV compliant merchant.
“We are pleased that QS/1, one of the leading pharmacy management software providers to independent, retail, chain and long-term care pharmacies, selected Heartland as one of the first processor/acquirers with which to certify for EMV,” Michael English, VP product development at Heartland, said. “QS/1's EMV protection against counterfeiting compliments the comprehensive suite of services QS/1 provides to their pharmacy customers, keeping them within HIPAA guidelines while streamlining customer service.”