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.

Autor:	Matsumura, Noriomi, Mandai, Masaki
Předmět:	DRUG approval MYELODYSPLASTIC syndromes BREAST cancer PROSTATE cancer REGULATORY approval DNA repair
Zdroj:	International Journal of Clinical Oncology; May2024, Vol. 29 Issue 5, p493-494, 2p
Abstrakt:	The International Journal of Clinical Oncology provides an update on the approval of new drugs by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Two drugs were approved in January 2024: talazoparib tosilate for BRCA mutation-positive castration-resistant prostate cancer and breast cancer, and luspatercept for anemia associated with myelodysplastic syndrome (MDS). Talazoparib tosilate inhibits DNA repair in tumor cells, leading to cell death and tumor suppression. Luspatercept promotes the differentiation of hematopoietic stem cells into erythrocytes, increasing the number of mature red blood cells. The PMDA also made revisions to precautions for certain drugs. The authors of the article have no conflicts of interest, and the publisher remains neutral. [Extracted from the article]
Databáze:	Complementary Index
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