PMDA regulatory update on approval and revision of the precautions for use of anticancer drugs in Japan; sevabertinib for lung cancer, gemcitabine intravesical system and durvalumab for bladder cancer, azacitidine for leukemia, cemiplimab for skin cancer, and ropeginterferon alfa-2b for essential thrombocythemia.

Key claim: Japan’s PMDA issued a regulatory update covering approval and precautions for ropeginterferon alfa-2b for essential thrombocythemia, among other anticancer drug actions.

Abstract

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Why this matters

Japan’s PMDA issued a regulatory update covering approval and precautions for ropeginterferon alfa-2b for essential thrombocythemia, among other anticancer drug actions.

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