FDA approves pembrolizumab with chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma
The FDA has approved the use of pembrolizumab in combination with chemotherapy for the treatment of unresectable advanced or metastatic malignant pleural mesothelioma. This approval provides a new therapeutic option for patients with this rare and aggressive cancer, which affects the lining of the lungs.
By combining pembrolizumab, an immune checkpoint inhibitor, with chemotherapy, the treatment aims to enhance the body’s immune response against the cancer while leveraging the benefits of traditional chemotherapy.
This approval marks an important advancement for those affected by mesothelioma, offering hope for improved outcomes in cases where surgical options are not feasible.
Merck & Co. Inc. announced on Wednesday that the US Food and Drug Administration (FDA) has approved its marketing authorization for Keytruda for the treatment of malignant pleural mesothelioma (MPM), a rare asbestos-related cancer.
According to the company, this is the first approval of Keytruda for the treatment of MPM in the US in combination with pemetrexed and platinum-based chemotherapy.
MPM is a rare and aggressive tumour strongly associated with asbestos exposure, with a five-year survival rate of 12%, according to the National Institutes of Health.
The approval is based on data from a phase 3 study in which Keytruda and chemotherapy showed a statistically significant improvement in overall survival compared to chemotherapy alone. Combination therapy reduced the risk of death by 21% in the final analysis of the trial.
Side effects were generally similar to those seen in other patients treated with Keytruda and chemotherapy, Merck said.
"We are pleased to offer a new first-line treatment option for adult patients with unresectable, advanced, or metastatic malignant pleural mesothelioma. The prognosis for this disease is generally unfavorable," Gregory Lubiniecki, Vice President of Clinical Oncology Research at Merck Research Laboratories, said in a statement.
In 2022, MPM was diagnosed in more than 30,000 people and killed more than 25,000 people. The tumor starts in the lining of certain parts of the body, such as the chest, abdomen, heart, and testicles.
Keytruda is approved worldwide for many indications and is expected to sell more than $25 billion by 2023. Last quarter, Keytruda sales grew 16% to $7.3 billion.
Regulators observed that adverse reactions were consistent with known toxicities linked to pembrolizumab, pemetrexed, and platinum-based chemotherapy.
The most frequently reported side effects included fatigue, diarrhea, pneumonitis, and immune-related reactions, as noted in earlier findings published in the Journal of Clinical Oncology. Additionally, researchers reported that 16% of patients discontinued pembrolizumab treatment, primarily due to diarrhea and pneumonitis.
The recommended dosage for pembrolizumab is 200 mg every three weeks or 400 mg every six weeks. Treatment can continue for up to two years or until disease progression or intolerable toxicity occurs
About Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma: Understanding the Disease
Malignant mesothelioma is a rare and aggressive type of cancer that originates in the mesothelium, the thin layer of tissue lining various organs of the body, including the chest (pleura), abdomen (peritoneum), heart (pericardium), and testicles (tunica vaginalis).
Among the different types, pleural mesothelioma—which affects the lining of the lungs—is the most prevalent, accounting for approximately 75% of all malignant mesothelioma cases.
Global Impact of Malignant Mesothelioma
The global burden of mesothelioma remains significant. In 2022, there were over 30,000 new cases of malignant mesothelioma diagnosed worldwide, with the disease contributing to more than 25,000 deaths. Mesothelioma’s high mortality rate is largely due to its aggressive nature and the difficulty of early detection, as symptoms often do not appear until the disease is in its advanced stages.
What is Malignant Pleural Mesothelioma?
Malignant pleural mesothelioma occurs when cancer cells develop in the pleura, the lining that surrounds the lungs and helps facilitate lung movement during breathing. The disease is most commonly associated with asbestos exposure, a known carcinogen, which was widely used in industries such as construction and manufacturing until its dangers became well-documented.
This form of mesothelioma is particularly challenging to treat due to its rapid progression. Once diagnosed, the disease often spreads quickly to other parts of the chest cavity and lungs. Despite advancements in treatment, the overall prognosis remains poor, and the disease continues to pose a significant health challenge for patients and medical professionals alike.
Survival Rates and Challenges
Malignant pleural mesothelioma is associated with a low long-term survival rate. Between 2014 and 2020, the five-year survival rate for all stages of mesothelioma cases in the U.S. was only 12.8%. This statistic highlights the aggressive nature of the disease and the limitations of current treatment options, which include surgery, chemotherapy, radiation therapy, and more recently, immunotherapy.
Early detection and prompt treatment are critical, but the asymptomatic nature of the early stages often results in delayed diagnoses, contributing to the low survival rate.
Malignant pleural mesothelioma remains a challenging and deadly cancer, primarily due to its strong association with asbestos exposure and its rapid progression. However, advancements in treatment provide new hope for patients.
In a significant development, the FDA approved pembrolizumab in combination with chemotherapy for the treatment of unresectable advanced or metastatic malignant pleural mesothelioma, offering a new therapeutic option that can potentially improve outcomes.
While early detection and awareness remain crucial for improving survival rates, this approval marks an important step forward in the fight against this aggressive disease.
For individuals at risk, especially those with a history of asbestos exposure, regular health monitoring and consultations with specialists are vital for managing this life-threatening condition.
Thanks for reading "FDA approves pembrolizumab with chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma" Also Read: Asbestos In Makeup, Blamed For Women's Mesothelioma
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