The U.S. Food and Drug Administration (FDA) has announced a historic approval for mesothelioma immunotherapy.
On Sept. 17, 2024, the FDA approved the immunotherapy drug Keytruda (pembrolizumab) as a first-line treatment for unresectable, malignant pleural mesothelioma. “Unresectable” means surgery is not a viable treatment option.
The FDA’s approval requires patients to use Keytruda in combination with mesothelioma chemotherapy. Keytruda is the brand name for the immunotherapy drug pembrolizumab.
What Is Keytruda?
Keytruda is a class of immunotherapy called immune checkpoint inhibitors. This type of immunotherapy targets a specific protein on the surface of cancer cells. Certain proteins on cancer cells can divert the immune system away from the disease, which allows tumors to grow and spread.
Keytruda blocks one such protein (PD-L1) to keep the immune system on high alert for mesothelioma cancer cells. The therapy is called a PD-L1 immune checkpoint inhibitor.
What the FDA Approval of Keytruda Means for Mesothelioma Patients
This latest FDA approval significantly increases the number of people who can receive Keytruda as a mesothelioma treatment.
The FDA previously approved Keytruda for patients with unresectable pleural mesothelioma that has a high volume of the protein PD-L1 in tumor cells. This was limited to less than 10% of people with the cancer. The approval also required patients to try chemotherapy first before turning to Keytruda.
Now, any person diagnosed with unresectable pleural mesothelioma can receive Keytruda as their first treatment.
“It is so exciting to see advancements in the treatment of mesothelioma,” says Mesothelioma Guide patient advocate and registered nurse Karen Ritter. “Immunotherapy is typically tolerated better by patients than chemotherapy, and it is showing more effectiveness than chemotherapy at slowing down or stopping the spread of tumors.”
Why the FDA Approved Keytruda for Mesothelioma
The FDA’s expanded approval of Keytruda comes following a phase 3 clinical trial called KEYNOTE-483. The trial analyzed how 440 mesothelioma patients responded to Keytruda with chemotherapy compared to chemotherapy alone.
Keytruda with chemotherapy improved the overall survival, progression-free survival, and objective response rate:
- Median survival for patients receiving Keytruda with chemotherapy was 17.3 months. Chemotherapy alone led to a median survival of 16 months.
- Approximately 52% of patients had a positive anti-tumor response thanks to Keytruda, compared to just 29% of patients receiving only chemotherapy.
- Approximately 26% of people receiving Keytruda had progression-free survival – meaning no signs of cancer advancing or growing – for at least one year. Only 17% of people receiving chemotherapy achieved this benchmark.
More About Mesothelioma
Mesothelioma is a rare and aggressive cancer caused by exposure to asbestos. The disease forms in specific tissue linings around the lungs, abdominal cavity, heart and testes. Approximately 2,500 people in the U.S. are diagnosed each year with mesothelioma. The average survival for patients is 1-2 years.
Pleural mesothelioma is the most common type of mesothelioma, accounting for 80% of all cases. It forms in the lining of the lungs. Pleural mesothelioma tumors can spread quickly to the lungs, which eliminates surgery as an option.
Other Approved Treatment Options for Mesothelioma
The FDA previously approved chemotherapy and immunotherapy to treat pleural mesothelioma:
- Chemotherapy combination of pemetrexed and cisplatin
- Immunotherapy combination of Opdivo (nivolumab) and Yervoy (ipilimumab)
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Sources & Author
- FDA approves pembrolizumab with chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma. U.S. Food and Drug Administration. Retrieved from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-chemotherapy-unresectable-advanced-or-metastatic-malignant-pleural. Accessed: 09/18/2024.
Sources & Author
