Research institute to evaluate clinical effectiveness, value of CAR-T for multiple myeloma
The Institute for Clinical and Economic Review is taking public comment for its planned assessment of chimeric antigen receptor T-cell therapies for the treatment of multiple myeloma.
The institute will compare the clinical effectiveness and value of idecabtagene vicleucel (Bristol Myers Squibb, bluebird bio) with ciltacabtagene autoleucel (Johnson & Johnson, Legend Biotech Corp.).
The open comment period begins today and continues until 5 p.m. Eastern on Sept. 17. It is intended “to allow stakeholders to share key information relevant to the development” of its evidence report, according to a press release issued by the independent, nonprofit research institute.
The report will be reviewed in April during a public meeting of the Midwest Comparative Effectiveness Public Advisory Council.
Neither CAR T-cell therapy being evaluated by the institute has been approved by the FDA for any indication. The FDA initially delayed the biologics license application for idecabtagene vicleucel earlier this year. The manufacturers resubmitted their application in July with additional requested data, and it is currently undergoing the full review process.
A biologics license application has yet to be submitted to the FDA for ciltacabtagene autoleucel.
More details about the open comment period and the type of information being sought are available at the institute’s website. Comments may be emailed to firstname.lastname@example.org.
The institute plans to have a draft scoping document on its planned analysis available by Sept. 22 and will take public comment on that document for 3 weeks.