Postpone the approval of anti-cancer drugs!

CompilationFan Dongdong

Former Celgene shareholders took Bristol-Myers Squibb (BMS) to court.

Bristol-Myers Squibb acquired Xinji for US$74 billion in November 2019.

However, former Xinji shareholders stated that one of the new CAR-T drugs, liso-cel, for the treatment of non-Hodgkin’s lymphoma, had not been approved by the FDA before December 31 last year, and the payment had disappeared out of thin air.

The lawsuit was filed by UMB Bank NA, headquartered in Kansas City, which served as the trustee of the former shareholders of Xinji.

UMB claims that Bristol-Myers Squibb made a “very atypical decision to exclude critical and mandatory information in its initial application”, and that the company spent another 2 months “delaying” its submission to the initial FDA The "significant revision" of the application has "automatically extended" the target date of the treatment's approval application to November 17, 2020.

The FDA conducted an inspection of a Lonza virus vector factory in Houston, USA from December 3 to 10 last year, which plans to help produce Breyanzi.

It is worth noting that the return of the CVR agreement also depends on the approval of two other former new base drugs on a specific date: Zeposia for multiple sclerosis and Abecma for multiple myeloma.

In this regard, Bristol-Myers Squibb has a different interpretation.

In the lawsuit, UMB argued that “other cell therapies based on similar technologies have been approved by the FDA, and there are no problems that have plagued Bristol-Myers Squibb, and the drug approval time should be greatly shortened.

Reference source: It had to happen: Ex-Celgene shareholders sue Bristol Myers Squibb for $6.