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Provisional application receives approval through the first international collaborative review initiative between TGA, FDA and HC

18 September 2019

The Therapeutic Goods Administration (TGA) has provisionally approved the use of lenvatinib (Lenvima®) in combination with pembrolizumab (Keytruda®) for the treatment of certain patients with advanced endometrial carcinoma.

This provisional approval provides a treatment option for patients with advanced endometrial carcinoma (that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)) who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication was approved via the new provisional approval pathway, based on objective response rate and response duration in a single-arm trial. Full registration for this indication depends on verification and description of clinical benefit in the confirmatory clinical trials.

This evaluation has been facilitated through the Project Orbis initiative of the United States Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) in which the FDA, Health Canada (HC), and the TGA received and collaboratively reviewed the application allowing for the simultaneous approval in all three countries. This innovative evaluation process has introduced efficiencies and established frameworks for process alignment and management of evaluation issues in real-time across jurisdictions.

Each regulatory agency has maintained its regulatory process to make an independent decision regarding approval (market authorisation) of the new indication.

Quick facts

  • Endometrial cancer is a disease in which cancer cells form in the tissues of the inner lining of the uterus (endometrium).
  • Endometrial cancer is the most common cancer of the female genital tract.
  • Surgery can be used to treat endometrial cancer in its earlier stages, but those with advanced disease require systemic therapy.
  • Provisional approval of this new treatment provides a new option for patients who previously had limited alternative available therapies.