Two weeks ago, we reported that pembrolizumab worked well as first-line treatment for advanced lung cancer patients. Those benefits―which included a 40% reduction in risk of death compared to chemotherapy―led the FDA to grant Breakthrough Therapy Designation and Priority Review to the therapy.
Although the FDA had until December 24 to make a decision, U.S. regulators decided yesterday, two months ahead of schedule, to approve pembrolizumab (Keytruda ®, Merck) as a first-line option for patients with advanced non-small cell lung carcinoma (NSCLC). It’s important to note, however, that this approval is for patients whose tumors have high PD-L1 expression (more than half the cells expressed it) and don’t have any mutations in EGFR or ALK. Pembrolizumab is an anti-PD-1 checkpoint antibody that targets the PD-1/PD-L1 pathway and can help keep immune cells active against cancer.
FDA Approves Another Immunotherapy Option for Patients with Advanced Lung Cancer
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*Immunotherapy results may vary from patient to patient.
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Supporters, scientists, patients, and advocates participated in CRI’s annual Wear White Day for a Future Immune to Cancer on June 14, 2019.
CRI hosted a Twitter Chat, moderated by STAT’s Sharon Begley, discussing takeaways from the ASCO19 conference last week.