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-Reference-Cited by-同舟云学术

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

Published:2024-04-30 Issue:7 Volume:29 Page:863-864
ISSN:1341-9625
Container-title:International Journal of Clinical Oncology
language:en
Short-container-title:Int J Clin Oncol

Author:

Matsumura Noriomi,Mandai Masaki

Publisher

Springer Science and Business Media LLC

Link

https://link.springer.com/content/pdf/10.1007/s10147-024-02531-1.pdf

Reference10 articles.

1. Pharmaceuticals and Medical Devices Agency (2024) List of approved drugs (in Japanese). https://www.pmda.go.jp/files/000252453.pdf Accessed on Mar 30, 2024

2. Lesokhin AM, Tomasson MH, Arnulf B et al (2023) Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results. Nat Med 29:2259–2267. https://doi.org/10.1038/s41591-023-02528-9

3. Lancet JE, Uy GL, Cortes JE et al (2018) CPX-351 (cytarabine and daunorubicin) Liposome for Injection Versus Conventional Cytarabine Plus Daunorubicin in Older Patients With Newly Diagnosed Secondary Acute Myeloid Leukemia. J Clin Oncol 36:2684–2692. https://doi.org/10.1200/JCO.2017.77.6112

4. Pennesi E, Brivio E, Ammerlaan ACJ et al (2024) Inotuzumab ozogamicin combined with chemotherapy in pediatric B-cell precursor CD22+ acute lymphoblastic leukemia: results of the phase IB ITCC-059 trial. Haematologica. https://doi.org/10.3324/haematol.2023.284409

5. Nakayama H, Ogawa C, Sekimizu M et al (2022) A phase I study of inotuzumab ozogamicin as a single agent in pediatric patients in Japan with relapsed/refractory CD22-positive acute lymphoblastic leukemia (INO-Ped-ALL-1). Int J Hematol 116:612–621. https://doi.org/10.1007/s12185-022-03388-8