Following confirmation of positive results, the U.S. Food and Drug Administration has approved the use of the immunotherapy drug pembrolizumab (Keytruda) for patients diagnosed with unresectable or metastatic malignant mesothelioma, as well as other solid tumor cancers.
Keytruda Use In Mesothelioma For Patients With High Mutation Levels and Without Other Options
The approval was specifically provided for patients with mesothelioma tumors and other tumors that contain levels of tissue tumor mutation that are considered high as determined by an FDA-approved test, whose disease has progressed despite having received other treatments and for whom there are no good alternatives available.
In explaining its rationale for approval of the innovative treatment, the FDA issued a press release indicating that clinical trials had shown a response rate of 29% in patients with mesothelioma and other tumors who demonstrated this particular mutation biomarker level. The agency referred to these results as “quite impressive,” and particularly in light of the challenges presented by these diseases.
Approval of Keytruda for Mesothelioma Patients Provided Under Accelerated Program
The FDA has indicated that the approval of Keytruda for use in mesothelioma is contingent upon verification of clinical benefit in future trials, and reports that the approval is supported by findings from an analysis of 10 cohorts of patients. The results were notably better than what was found in patients whose tumor mutation levels were not categorized as high.
The positive results gathered from the ten cohorts showed complete responses in 4% of patients and partial responses in 25%. More than half of the patients in the study were able to gain a benefit for at least one year, and half of that group had responses of at least two years. Speaking of the approval, Roy S. Herbst, MD, PhD, ensign professor of medicine (medical oncology) and professor of pharmacology, Yale School of Medicine; chief of medical oncology, Yale Cancer Center and Smilow Cancer Hospital; and associate cancer center director for translational research, Yale Cancer Center, said, “As physicians, we are always looking to find new options for patients, especially in the second-line or higher treatment setting. It’s great to see the use of innovative biomarkers and immunotherapy come together with this approval and encouraging that we now have an option for patients with TMB-H tumors across cancer types, including rare cancers.”
For mesothelioma patients, news of expanded treatment options approved by the FDA is very encouraging. For information on treatment centers offering state of the art options, contact the Patient Advocates at Mesothelioma.net today at 1-800-692-8608.