Bluebird bio is hoping for an FDA OK for three of its experimental drugs by 2019, including the CAR-T bb2121 partnered with Celgene hat caused a buzz at ASH.
That’s according to the company’s CEO Nick Leschly, who announced bluebird’s ambitious plans during his presentation at JPM.
The CAR-T, meant to treat multiple myeloma, is a new BCMA-targeting therapy that has posted some stellar clinical results in an early-stage study. The FDA already gave the program breakthrough therapy designation. The CAR-T was the star of ASH when blurbird reported extremely high response and remission rates with good safety in a small study.
Leschly said Celgene will file for US and European approval of the therapy by the end of 2019.
Bluebird, which has no approved products on the market yet, plans to ask for regulatory approval for two additional pipeline drugs by 2019: its gene therapy LentiGlobin (by 2018) and another gene therapy for cerebral adrenoleukodystrophy.
He said the company is still trying to nail down “the right pricing and reimbursement strategy” for treatments expected to be extremely expensive. The first two approved CAR-T treatments for other cancers from Novartis and Gilead Sciences were priced at $475,000 and $373,000, respectively, for the one-time treatments.
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