A CAR-T race intensifies
It’s been 2 1/2 years since the U.S. Food and Drug Administration approved the pioneering CAR-T therapy known as Kymriah, manufactured by Novartis. But CAR-T has not yet broken into the enormous market that is China.
Now, it looks like only a matter of time before it does.
On Monday, China’s National Medical Products Administration said that it had accepted an application for Gilead's CAR-T, Yescarta, submitted by Fosun Kite Biotechnology. That entity is a partnership of Kite Pharma, a unit of Gilead, and Shanghai Fosun Pharmaceutical Co., announced in 2017.
Meantime, the NMPA disclosed recently that it has given the go-ahead to Novartis’ clinical trial application for CTL019, otherwise known as tisagenlecleucel, the scientific name for Kymriah.
The approved trial will be part of the Swiss pharma giant’s BELINDA study, a Phase 3 trial comparing the safety and efficacy of Kymriah with the standard of care in patients with an aggressive form of B-cell non-Hodgkin lymphoma, Novartis told STAT.
“We are actively working on trial initiation activities. The goal is to recruit 318 patients worldwide, and the study is currently ongoing globally,” a company spokesman told STAT.
Now, it looks like only a matter of time before it does.
On Monday, China’s National Medical Products Administration said that it had accepted an application for Gilead's CAR-T, Yescarta, submitted by Fosun Kite Biotechnology. That entity is a partnership of Kite Pharma, a unit of Gilead, and Shanghai Fosun Pharmaceutical Co., announced in 2017.
Meantime, the NMPA disclosed recently that it has given the go-ahead to Novartis’ clinical trial application for CTL019, otherwise known as tisagenlecleucel, the scientific name for Kymriah.
The approved trial will be part of the Swiss pharma giant’s BELINDA study, a Phase 3 trial comparing the safety and efficacy of Kymriah with the standard of care in patients with an aggressive form of B-cell non-Hodgkin lymphoma, Novartis told STAT.
“We are actively working on trial initiation activities. The goal is to recruit 318 patients worldwide, and the study is currently ongoing globally,” a company spokesman told STAT.
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