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Phase III fast track for Leclaza¡¤Lynparza was approved

By Lee, Jeong-Hwan | translator Choi HeeYoung

21.02.05 06:18:33

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In the case of Eisai's Symbenda¡¤Samsung's Riavax, the indication has been deleted



While a bill was proposed to upgrade the fast track system in phase III to the pharmaceutical affairs law from the public announcement, 62 new drugs were counted to have taken the fast track so far.

Most of domestic and overseas anticancer drugs such as Leclaza (Lasertinib) developed by Yuhan, AstraZeneca's Lynparza, Tagrisso (Osimertinib), and Pfizer's Ibrance (Palbociclib), are fast tracked. Biosolution's CartiLife and Tego Science¡¯s Rosmir were also included.

On the 4th, the drugs approved by the MFDS for Phase III clinical trial, including drugs related to rare diseases and intractable diseases, as well as anticancer drugs and cell therapy drugs, received special cases of fast track.

Lee, Jeong-Hwan(junghwanss@dailypharm.com)
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