FDA Approves Keytruda With Chemotherapy to Treat Mesothelioma
The U.S. Food and Drug Administration has approved a new first-line treatment for people with pleural mesothelioma that can’t be removed with surgery. This new approval is specifically for a Keytruda (pembrolizumab) plus pemetrexed and platinum chemotherapy combination.
The FDA’s approval follows promising results in phases 2 and 3 of the Keynote-483 trial. This clinical trial involved 440 patients with advanced or metastatic malignant pleural mesothelioma whose cancer couldn’t be removed with surgery. These patients also hadn’t received prior systemic therapy.
The Keytruda regimen was compared against Alimta (pemetrexed) with cisplatin or carboplatin as well as chemotherapy drugs alone. Keynote-483 results show benefits against both the Alimta regimen and the chemotherapy alone regimen.
Compared to the Alimta regimen, the Keytruda option showed significant survival benefits of Keytruda, cutting the risk of death 21%. Keytruda reduced the likelihood of death or disease progression 20% compared to chemotherapy alone.
Median overall survival was 17.3 months for patients who received the Keytruda combo. With chemotherapy alone, the median overall survival was 16.1 months.
FDA officials also indicate the Keytruda regimen appears to be as safe as receiving chemotherapy alone. They say adverse reactions in patients with metastatic malignant pleural mesothelioma were similar to those receiving Keytruda with pemetrexed and platinum chemotherapy.
The FDA notes, “This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with the Australian Therapeutic Goods Administration (TGA) and Health Canada.”
New Hope for Mesothelioma Patients
Doctors typically diagnose mesothelioma at an advanced stage. As a result, treatment options can be limited.
The prognosis for mesothelioma is generally poor with a 5-year survival rate of 12%. This newly FDA-approved combo of Keytruda with chemotherapy may set a new standard of mesothelioma treatment.
This new option joins Opdivo (Nivolumab) combined with Yervoy (Ipilimumab) as FDA-approved first-line treatments for mesothelioma. Additional clinical trials are underway to continue improving treatment options for mesothelioma.
History of Keytruda
Keytruda is an immunotherapy drug that binds to a type of immune cell. This prevents cancer cells from suppressing the immune system. This in turn enables the immune system to attack and kill cancer cells.
- Blisters
- Constipation
- Cough
- Decreased appetite
- Diarrhea
- Feeling tired or weak
- Fever
- Hair loss
- Joint pain
- Muscle pain
- Nausea
- Rash
- Swelling
- Trouble breathing
- Trouble sleeping
- Urinary tract infection
- Vomiting
The FDA has approved Keytruda for the treated of melanoma, non-small cell lung cancer and head and neck cancers. You can use it alone or with other drugs.
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