FDA Grants Breakthrough Therapy Designation to Keytruda® for First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Keytruda® (pembrolizumab) for first-line treatment of patients with advanced non-small cell lung cancer (NSCLC).
The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of a drug that is planned for use to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
Lung cancer remains the leading cause of cancer-related deaths worldwide. In the United States, NSCLC accounts for 75–80% of all lung cancers. Although progress has been made in recent years, the majority of patients with advanced stage lung cancer still die from their disease. New treatments are needed. Precision medicine continues to impact the lives of lung cancer patients with research into genomics and genetics leading to unprecedented progress in improving outcomes. Tailored treatments have emerged to match a person’s genetic makeup or a tumor’s genetic profile. As a result, patients with lung cancer now typically receive molecular testing that guides their physicians in determining which therapies are more likely to boost the chances of survival while limiting the potential for adverse effects. Results from studies evaluating immunomodulatory approaches using anti-PD-1 and anti-PD-L1 antibodies have demonstrated promising results and are advancing the standard of care for lung cancer.
The FDA’s decision to grant breakthrough therapy status was based on data from the KEYNOTE-024 study, which showed that Keytruda resulted in superior progression-free survival (PFS) as well as overall survival (OS) compared with standard chemotherapy in patients with advanced NSCLC whose tumors expressed high levels of PD-L1. Based on the results, the trial was stopped early to give patients still on chemotherapy the opportunity to receive Keytruda.
Keytruda is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Keytruda blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Chemotherapy has been the foundation of first-line treatment for non-small cell lung cancer for decades, so this reported improvement in survival in patients with high PD-L1 expression seen with Keytruda compared to chemotherapy is welcome news and may represent the beginning of better tolerated and more effective treatment for early stage lung cancers.
Reference: Merck. (2016.) FDA Accepts Supplemental Biologics License Application, Assigns Priority Review and Grants Breakthrough Therapy Designation to Merck’s KEYTRUDA® (pembrolizumab) for First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer. [Press release.] Retrieved from: http://www.mercknewsroom.com/news-release/oncology-newsroom/fda-accepts-supplemental-biologics-license-application-assigns-priori
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