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For several head CAR-T cell therapy companies, expanding the indications of their CAR-T products to the front line is undoubtedly one of the important ways to improve product competitiveness and seize market leadership
Currently in the United States, the five approved CAR-T products are all third-line post-therapies, from Novartis, BMS, and Gilead
CAR-T products that have been approved for listing abroad
As of December 2021, Insight database collation
Since June of this year, CAR-T second-line therapy has been filled with smoke, and three leading companies have successively released three phases of data
At the recent ASH conference, Gilead expanded the front line to the field of first-line treatment
From: Gilead official website
ZUMA-12 is an open-label, global multicenter single-arm phase 2 clinical trial.
The results showed that after a single infusion of Yescarta, 89% of evaluable patients achieved remission (ORR), of which 78% achieved complete remission (CR) at a median follow-up of 15.
In terms of safety, the results observed in ZUMA-12 are consistent with Yescarta's previous data
At the same time, in this ASH conference, Gilead also announced a number of Yescarta data, including the first key clinical 5-year survival data (ZUMA-1 study), the latest data of the second-line treatment R/RLBCL (ZUMA-7 Study), two-year updated data for relapsed or refractory indolent non-Hodgkin’s lymphoma (including follicular lymphoma) (ZUMA-5 study)
From: Gilead official website
ZUMA-1 study: 5-year survival rate reaches 42.
Yescarta is the first CAR-T therapy to publish 5-year survival data
Second-line therapy: sBLA has been submitted and is expected to be approved in 2022H1
Second-line therapy: sBLA has been submitted and is expected to be approved in 2022H1The ZUMA-7 study was launched in 2017.
With a median follow-up of more than two years, the study reached the primary endpoint of event-free survival (EFS; hazard ratio 0.
In October of this year, Gilead has submitted an sBLA application for Yescarta's second-line indication to the FDA and was granted priority review.
The first approved CAR-T therapy Akirensai injection in China is a product produced locally by Fosun Kate based on Yescarta® technology transfer
From: CDE official website
