Guest Blog by: Elvin Montanez, Pharm.D.
Even more cancer patients might soon be benefiting from the cancer medication that helped former President Jimmy Carter. Keytruda (pembrolizumab) first started saving lives back in 2011 when a human trial led to an expedited process with the Food and Drug Administration (FDA). By 2014, this medication was approved for melanoma, with approval for non-small cell lung cancer in patients who did not see success with other chemotherapy options following the next year. Keytruda is also approved for head and neck cancers.
As an immunotherapy medication, Keytruda is a humanized antibody that targets the programmed cell death 1 (PD-1) receptor in cancer cells. It’s given as an intravenous infusion over 30 minutes every 3 weeks to cancer patients.
Currently, the FDA ruled favorably on Merck’s Supplemental Biologics License Application for Keytruda as the first-line treatment of advanced non-small cell lung cancer – meaning that this medication now has Priority Review status. Consequently, patients might soon be prescribed Keytruda as the first treatment for their cancer, if their tumor expresses PD-L1.
The FDA was impressed by the KEYNOTE-024 study results from patients treated with Keytruda as the first-line treatment for advanced non-small cell lung cancer whose tumors expressed high levels of PD-L1. The dosage of Keytruda was 200 mg. every three weeks, which was compared to a set of patients treated with platinum-based chemotherapy, for a total of 305 patients. Keytruda treatment was superior to chemotherapy for both progression-free survival and overall survival. In fact, the benefit was so striking that the trial was suspended so all the chemotherapy patients could also receive Keytruda.
At this point, it seems likely that Keytruda will be approved as the first-line treatment option for non-small cell lung cancer. A decision is expected before the end of the year (by December 24, 2016).
Study of pembrolizumab (MK-3475) compared to platinum-based chemotherapies in participants with metastatic non-small cell lung cancer (MK-3475-024/KEYNOTE-024). ClinicalTrials.gov Identifier: NCT02142738.
Toich L. FDA to evaluate Keytruda as first line lung cancer treatment. Sp Pharm Times September 13, 2016.