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Today, the official website of the State Food and Drug Administration shows that Hengrui's new indication of karylizumab for injection (registration classification: 2.
2) is already in the "under review" status and is expected to be approved by the NMPA in the near future
.
2) is already in the "under review" status and is expected to be approved by the NMPA in the near future
.
The indications to be approved this time are: combined cisplatin and gemcitabine for the first-line treatment of patients with locally recurring or metastatic nasopharyngeal carcinoma
.
After approval, it will be the sixth indication approved for carrelizumab
On August 13 last year, Hengrui issued an announcement on a randomized, double-blind, placebo-controlled, multicenter phase III clinical study of carrelizumab combined with cisplatin and gemcitabine in the first-line treatment of locally recurring or distant metastatic nasopharyngeal carcinoma ( CAPTAIN-1st) The results of the interim analysis reached the superiority standard preset by the program
.
The CAPTAIN-1st study is a randomized, double-randomized, double-destination study evaluating the effectiveness and safety of carrelizumab combined with cisplatin and gemcitabine for injection versus placebo combined with cisplatin and gemcitabine in the first-line treatment of locally recurring or metastatic nasopharyngeal carcinoma.
A blinded, placebo-controlled, multi-center phase III clinical study (CTR20181864, NCT03707509), with Professor Zhang Li from the Cancer Hospital of Sun Yat-sen University as the main investigator
.
The main endpoint of the study was progression-free survival (PFS) assessed by the Independent Review Committee (IRC) according to the RECIST v1.
A total of 250 subjects were enrolled in the study, randomly enrolled according to 1:1, and received carrelizumab for injection or placebo combined with cisplatin and gemcitabine for 4-6 cycles of combined treatment, and then received card for injection.
The results of the study showed that carrelizumab for injection combined with cisplatin and gemcitabine for first-line treatment of patients with local recurrence or distant metastasis of nasopharyngeal carcinoma can significantly prolong the progression-free survival of patients compared with standard first-line treatment of cisplatin and gemcitabine
At present, only Junshi and Hengrui have applied for the market for nasopharyngeal cancer indications.
According to the information of the enterprise exchange meeting, the sales of Karelizumab in 2020 are about 4.
