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  6. FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for unresectable advanced or metastatic malignant pleural mesothelioma
  1. Resources for Information | Approved Drugs

FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for unresectable advanced or metastatic malignant pleural mesothelioma

Podcast

Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval.

On September 17, 2024, the FDA approved pembrolizumab (brand name Keytruda) with pemetrexed and platinum chemotherapy as first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma.

Efficacy was investigated in KEYNOTE-483, a randomized, open-label trial in patients with unresectable advanced or metastatic malignant pleural mesothelioma and no prior systemic therapy for advanced/metastatic disease. Patients were randomized 1:1 to receive either pembrolizumab for up to 2 years in combination with pemetrexed and platinum-based chemotherapy for up to 6 cycles or pemetrexed and platinum-based chemotherapy for up to 6 cycles.

The main efficacy outcome measure was overall survival. Additional efficacy outcome measures were progression-free survival, objective response rate, and duration of response, as assessed by blinded independent central review, according to modified RECIST 1.1 for mesothelioma. The trial demonstrated a statistically significant improvement in overall survival for patients treated with pembrolizumab with chemotherapy compared to those who received chemotherapy alone. Median overall survival was 17.3 months versus 16.1 months.

Median progression-free survival was 7.1 months vs 7.1 months in pembrolizumab plus chemotherapy and the chemotherapy alone arm, respectively. Confirmed objective response rate was 52% in the pembrolizumab plus chemotherapy arm and 29% in the chemotherapy alone arm. Median duration of response was 6.9 months and 6.8 months, respectively.

Adverse reactions occurring in patients with MPM were similar to those receiving pembrolizumab with pemetrexed and platinum chemotherapy. See the prescribing information for complete details.

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. The application reviews are ongoing at the other regulatory agencies.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

Full prescribing information for these approvals can be found on the web at www.fda.gov/drugsatfda.

Health care professionals should report serious adverse events to www.fda.gov/medwatch.

Follow the Division of Drug Information on X @FDA_Drug_Info and the Oncology Center of Excellence @FDAOncology. Send your feedback via email to FDAOncology@fda.hhs.gov. Thanks for tuning in to the D.I.S.C.O. Burst Edition.

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