On May 29, 2024, the U.S. Food and Drug Administration (FDA) granted a priority review of Keytruda® (pembrolizumab) combined with chemotherapy as a first-line (initial) treatment for patients with pleural mesothelioma that is inoperable or has spread to other parts of the body.

This priority review is a big step toward making Keytruda more widely available to mesothelioma patients. The FDA has set September 24, 2024, as a target action date for its review.

“We continue to evaluate Keytruda in new and difficult-to-treat tumors and look forward to working with the FDA to help bring Keytruda as a potential treatment option to certain patients with advanced malignant pleural mesothelioma,” said Dr. Gregory Lubiniecki, vice president of oncology clinical research at Merck, the company that makes Keytruda.

Keytruda is an immunotherapy drug that’s already FDA approved as a second-line (follow-up) treatment for some cases of mesothelioma. It blocks PD-1, a protein that immune T cells use to determine which cells are good and bad. This helps them kill cancer cells that try to hide from the immune system.

Download our Free Immunotherapy Guide to learn more about the benefits of Keytruda and other immunotherapy drugs for mesothelioma.

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About KEYNOTE-483: Keytruda Mesothelioma Clinical Trial

The FDA’s priority review is grounded in the results of a recent clinical trial known as IND.227/KEYNOTE-483.

In the KEYNOTE-483 trial, 440 patients with advanced, inoperable pleural mesothelioma received either Keytruda and chemotherapy or chemotherapy alone.

Patients receiving Keytruda with chemotherapy experienced statistically significant improvements in survival compared to those who received chemotherapy.

When treated with Keytruda and chemotherapy, patients had a:

  • 3-year survival rate of 25%, while the 3-year survival rate with chemotherapy alone was 17%
  • 21% reduced risk of death
  • Significantly higher response rate, with 62% of Keytruda patients responding compared to just 38% of patients treated with chemotherapy alone

In addition, patients who received both Keytruda and chemotherapy had a slightly longer median life expectancy of 17.3 months, compared to 16.1 months in the chemotherapy patients.

Use our Free Doctor Match to find mesothelioma specialists who can help you access trials testing Keytruda and other immunotherapies.

What Does Keytruda’s Priority Review Mean for Mesothelioma Patients?

With the encouraging results from the KEYNOTE-483 clinical trial and the priority review speeding up the FDA’s evaluation process, Keytruda could soon reach many more patients.

This is very encouraging, as Keytruda may give pleural mesothelioma patients with inoperable cancer another, potentially more effective option to live longer.

“Malignant pleural mesothelioma is typically diagnosed in advanced stages when curative surgery is not an option and progresses quickly,” explained Dr. Lubiniecki.

Given the aggressive nature of pleural mesothelioma, Keytruda could provide a much-needed lifeline and set a new standard of care for those affected by this rare cancer.

Get FDA Keytruda Mesothelioma Updates & Help Now

At Mesothelioma Hope, our team of Patient Advocates is dedicated to helping patients get the medical and financial support they need after a diagnosis.

We are closely monitoring the FDA’s priority review of Keytruda and will provide updates as needed. We can also help you pursue immunotherapies and other treatments that could improve your survival.

“Answering patient questions, explaining options, and sometimes just listening to a patient and their loved one is the number one reason why I’m here.”

- Quote from Amy Fair, RN, Mesothelioma Hope Patient Advocate

Call us now at (866) 608-8933 or download our Free Immunotherapy Guide to learn more about how these treatments could help you or a loved one after a mesothelioma diagnosis.

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Laura WrightWritten by:

Lead Editor

Laura Wright is a journalist and content strategist with more than 15 years of professional experience. She attended college at the University of Florida, graduating magna cum laude with a bachelor’s degree in journalism in 2008. Her writing has been featured in The Gainesville Sun and other regional publications throughout Florida.

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  1. Business Wire. (2024, May 29). FDA Grants Priority Review to Merck’s Application for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as First-Line Treatment of Patients With Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma. Retrieved May 31, 2024, from https://www.businesswire.com/news/home/20240529865307/en/FDA-Grants-Priority-Review-to-Merck’s-Application-for-KEYTRUDA®-pembrolizumab-Plus-Chemotherapy-as-First-Line-Treatment-of-Patients-With-Unresectable-Advanced-or-Metastatic-Malignant-Pleural-Mesothelioma
  2. Seymour, C. (2024, May 29). FDA Grants Priority Review to Pembrolizumab Plus Chemotherapy for Advanced Pleural Mesothelioma. Retrieved May 31, 2024, from https://www.onclive.com/view/fda-grants-priority-review-to-pembrolizumab-plus-chemotherapy-for-advanced-pleural-mesothelioma

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