Item 8.01 Other Events.

On May 13, 2020, bluebird bio, Inc. ("bluebird") and Bristol Myers Squibb Company announced that the companies received a Refusal to File letter from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for idecabtagene vicleucel (ide-cel; bb2121) for patients with heavily pre-treated relapsed and refractory multiple myeloma, which was submitted in March 2020.

Upon preliminary review, the FDA determined that the Chemistry, Manufacturing and Control (CMC) module of the BLA requires further detail to complete a substantive review. Based on this review, the FDA advised the companies that supplemental information detailing the validation and control processes used in the lentiviral vector and drug product manufacturing processes for ide-cel are required in order to complete the BLA submission. The FDA letter did not reflect concerns with the safety or efficacy profile of ide-cel and did not request that the companies conduct additional clinical studies.

The full text of bluebird's press release regarding this announcement is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.



(d) Exhibits
    Exhibit
      No.                                             Description
     99.1               Press release issued by bluebird bio, Inc. on May 13, 2020.
      104             Cover Page Interactive Data File (embedded within the Inline XBRL document)

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