Provisional approval of lenvatinib in combination with pembrolizumab for the treatment of advanced endometrial carcinoma

TGA

18 September 2019 - The Therapeutic Goods Administration 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 or mismatch repair deficient) 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.

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Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , Australia