共 8 条
- [1] PMDA regulatory update on approval of new drugs and revisions of precautions; approval of talazoparib tosilate for prostate and breast cancer, and luspatercept for myelodysplastic syndrome in Japan International Journal of Clinical Oncology, 2024, 29 : 493 - 494
- [5] PMDA regulatory update on approval and revision of the precautions for use of anticancer drugs; approval of pembrolizumab for locally advanced uterine cervical cancer, and durvalumab and olaparib for advanced or recurrent endometrial cancer in Japan INTERNATIONAL JOURNAL OF CLINICAL ONCOLOGY, 2025, 30 (02) : 170 - 171
- [6] PMDA regulatory update on approval and revision of the precautions for use of anticancer drugs; approval of elranatamab for multiple myeloma, CPX-351 for myeloid leukemia, inotuzumab ozogamicin for lymphoblastic leukemia, capivasertib for breast cancer, and zolbetuximab for gastric cancer in Japan INTERNATIONAL JOURNAL OF CLINICAL ONCOLOGY, 2024, 29 (7) : 863 - 864
- [7] PMDA regulatory update on approval and revision of the precautions for use of anticancer drugs; approval of sacituzumab govitecan for breast cancer, fruquintinib for colorectal cancer, amivantamab for lung cancer, repotrectinib for lung cancer, tasurgratinib for biliary tract cancer, enfortumab vedotin plus pembrolizumab for urothelial cancer, and dabrafenib plus trametinib for glioma in Japan INTERNATIONAL JOURNAL OF CLINICAL ONCOLOGY, 2024, 29 (12) : 1775 - 1776
- [8] PMDA regulatory update on approval and revision of the precautions for use of anticancer drugs: approval selpercatinib for solid tumor with RET fusion, gumarontinib for non-small cell lung cancer with MET gene exon 14 skipping mutation, momelotinib for myelofibrosis, bexarotene for adult T-cell leukemia/lymphoma, valemetostat for peripheral T-cell lymphoma, and pirtobrutinib for mantle cell lymphoma in Japan INTERNATIONAL JOURNAL OF CLINICAL ONCOLOGY, 2024, 29 (09) : 1207 - 1208