• FDA set a target action date of March 27, 2021
• Ide-cel is the first CAR T cell ther­apy ac­cepted for regu­la­tory re­view for mul­ti­ple myeloma

Princeton, NJ and Cambridge, MA (Press Release) – Bristol Myers Squibb (NYSE: BMY) and blue­bird bio, Inc. (Nasdaq: BLUE) to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) has ac­cepted for Priority Review their Biologics License Appli­ca­tion (BLA) for idecabtagene vicleucel (ide-cel; bb2121), the com­pa­nies’ inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA)-directed chi­meric an­ti­gen re­cep­tor (CAR) T cell immuno­therapy, for the treat­ment of adult patients with mul­ti­ple myeloma who have re­ceived at least three prior ther­a­pies, in­clud­ing an immuno­modu­la­tory agent, a pro­te­a­some in­hib­i­tor and …

• BLA sub­mission based on re­­sults from pivotal Phase 2 KarMMa study eval­u­ating ide-cel in heavily pre-treated patient pop­u­la­tion
• Companies are com­mit­ted to work­ing with the FDA to rapidly ad­vance ide-cel through the regu­la­tory re­­view process

Princeton, NJ and Cambridge, MA – Bristol Myers Squibb (NYSE: BMY) and blue­bird bio, Inc. (Nasdaq: BLUE) to­day an­nounced the sub­mission of their Bio­logics License Appli­ca­tion (BLA) to the U.S. Food and Drug Admin­istra­tion (FDA) for idecabtagene vicleucel (ide-cel; bb2121), the com­pa­nies’ inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA)-directed chi­meric an­ti­gen re­cep­tor (CAR) T cell immuno­therapy, for the treat­ment of adult patients with re­lapsed and re­frac­tory mul­ti­ple myeloma. This sub­mission provides fur­ther details on the Chemistry, Manu­fac­tur­ing and Con­trols (CMC) module to address the out­stand­ing …

Applications based on pos­i­tive results from pivotal KarMMa study in re­lapsed and re­frac­tory mul­ti­ple myeloma and QUAZAR®-AML-001 study in acute myeloid leukemia

Princeton, NJ (Press Release) – Bristol Myers Squibb (NYSE: BMY) to­day an­nounced that the Euro­pean Medicines Agency (EMA) has val­i­dated its Marketing Authori­za­tion Appli­ca­tions (MAA) for both idecabtagene vicleucel (ide-cel, bb2121) and CC-486. Validation of each appli­ca­tion con­firms the re­spec­tive sub­missions are com­plete and begins the EMA’s centralized review process.

The MAA for ide-cel, the com­pany’s inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA)-directed chi­meric an­ti­gen re­cep­tor (CAR) T cell immuno­therapy co-developed with bluebird bio, Inc., is for the treat­ment of adult patients with mul­ti­ple myeloma who have re­ceived at least three prior ther­a­pies, in­clud­ing an immuno­modu­la­tory …

• Bristol Myers Squibb to host an in­vestor call to­day at 8:00 a.m. EDT
• bluebird bio to host an in­vestor call to­day at 8:45 a.m. EDT

Princeton, NJ and Cambridge, MA (Press Release) – Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) to­day 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 …

• Bristol Myers Squibb to buy out its ex-U.S. mile­stone and royalty obli­ga­tions to bluebird bio for $200 million
• Bristol Myers Squibb assumes re­spon­si­bil­ity­ for vector manu­fac­tur­ing in ex-US territories
• bluebird to hold conference call and webcast to­day, May 11, 2020 at 8:00AM ET

Cambridge, MA (Press Release) – bluebird bio, Inc. (NASDAQ: BLUE) to­day an­nounced that it has amended its existing co-promotion / co-development agree­ment with Bristol Myers Squibb (BMS) to enable the com­pa­nies to focus their efforts on efficient com­mer­cial­iza­tion of idecabtagene vicleucel (ide-cel; bb2121) in the U.S., the com­pa­nies’ lead inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA)-directed chi­meric an­ti­gen re­cep­tor (CAR) T cell immuno­therapy, cur­rent in review with the FDA.

“Under our amended col­lab­o­ration, we and BMS are redoubling our com­mitment to ide-cel …

BLA sub­mission in­cludes results from pivotal Phase 2 KarMMa study eval­u­ating ide-cel in a heavily pre-treated patient pop­u­la­tion with re­lapsed and re­frac­tory mul­ti­ple myeloma

Princeton, NJ and Cambridge, MA (Press Release) – Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) to­day an­nounced the sub­mission of their Biologics License Appli­ca­tion (BLA) to the U.S. Food and Drug Admin­istra­tion (FDA) for idecabtagene vicleucel (ide-cel; bb2121), the com­pa­nies’ lead inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA)-directed chi­meric an­ti­gen re­cep­tor (CAR) T cell immuno­therapy, for the treat­ment of adult patients with mul­ti­ple myeloma who have re­ceived at least three prior ther­a­pies, in­clud­ing an immuno­modu­la­tory agent, a pro­te­a­some in­hib­i­tor and an anti-CD38 anti­body.

The sub­mission is based on results from …

• Study met its pri­mary end­point and key sec­ond­ary end­point, demonstrating deep and durable re­sponse­s in a heavily pre-treated mul­ti­ple myeloma patient pop­u­la­tion
• Safety results are con­sis­tent with the data pre­sented in CRB-401 study

Princeton, NJ and Cambridge, MA (Press Release) – Bristol-Myers Squibb Com­pany (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) to­day an­nounced pos­i­tive top-line results from KarMMa, a pivotal, open-label, single arm, multi­center, Phase 2 study of idecabtagene vicleucel (ide-cel; bb2121). KarMMa, which eval­u­ated the ef­fi­cacy and safety of the com­pa­nies’ lead inves­ti­ga­tional BCMA-targeted chi­meric an­ti­gen re­cep­tor (CAR) T cell ther­apy can­di­date for patients with re­lapsed and re­frac­tory mul­ti­ple myeloma, met its pri­mary end­point and key sec­ond­ary end­point.

KarMMa en­rolled 140 patients, of whom 128 …