• 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 …

London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) to­day an­nounced the Com­mit­tee for Medicinal Products for Human Use (CHMP) of the Euro­pean Medicines Agency (EMA) adopted a pos­i­tive opinion rec­om­mending the ap­prov­al of be­lan­ta­mab mafo­dotin as mono­therapy for the treat­ment of mul­ti­ple myeloma in adult patients, who have re­ceived at least four prior ther­a­pies and whose dis­ease is re­frac­tory to at least one pro­te­a­some in­hib­i­tor, one immuno­modu­la­tory agent, and an anti-CD38 mono­clonal anti­body, and who have dem­onstrated dis­ease pro­gres­sion on the last ther­apy.

Dr Axel Hoos, Senior Vice Pres­i­dent and Head …

Newton, MA (Press Release) – Karyo­pharm Thera­peutics Inc. (Nasdaq:KPTI), an inno­va­tion-driven pharma­ceu­tical com­pany, to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) has ac­cepted for filing its supple­mental New Drug Appli­ca­tion (sNDA) seek­ing ap­prov­al for XPOVIO^® (seli­nexor), its first-in-class, oral Sel­ective Inhibitor of Nuclear Export (SINE) com­pound, as a new treat­ment for patients with mul­ti­ple myeloma after at least one prior line of ther­apy. Karyo­pharm ex­pects a de­ci­sion from the FDA re­gard­ing this sNDA before the end of the first quarter of 2021.

“This sNDA ac­ceptance brings us one step closer to …

• Recommendation based on re­view of DREAMM clin­i­cal trial pro­gramme, in­clud­ing the pivotal DREAMM-2 study
• If approved, be­lan­ta­mab mafo­dotin will be a first-in-class anti-BCMA ther­apy for the treat­ment of re­lapsed / re­frac­tory mul­ti­ple myeloma

London, United Kingdom (Press Release) – GlaxoSmithKline to­day an­nounced the US Food and Drug Admin­istra­tion (FDA) Oncologic Drugs Advisory Com­mit­tee (ODAC) voted 12-0 in favour of the dem­onstrated ben­e­fit of mono­therapy treat­ment with be­lan­ta­mab mafo­dotin outweighing the risks for patients with re­lapsed or re­frac­tory mul­ti­ple myeloma who have re­ceived at least four prior ther­a­pies in­clud­ing an immuno­modu­la­tory agent, a pro­te­a­some in­hib­i­tor and an anti-CD38 anti­body. Two com­mit­tee members could not par­tic­i­pate in the final vote.

Dr Axel Hoos, Senior Vice Pres­i­dent and Head of …

• First and only anti-CD38 anti­body in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (pom-dex) to be approved in Canada^1,2
• SARCLISA™ in com­bi­na­tion with pom-dex sig­nif­i­cantly reduced the risk of dis­ease pro­gres­sion or death by 40% com­pared to pom-dex alone in a pivotal trial²
• Multiple myeloma is the third most common blood cancer in Canada³

Mississauga, ON (Press Release) – Sanofi Canada is pleased to an­nounce that Health Canada has approved SARCLISA™ in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone for the treat­ment of adults with re­lapsed and re­frac­tory mul­ti­ple myeloma (RRMM) who have re­ceived at least two prior ther­a­pies in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor.²

"Immunotherapies like SARCLISA™ leverage the im­mune sys­tem to fight mul­ti­ple myeloma and we're seeing real progress in their ability to help patients. This was not the case over a decade ago," says Dr. …

Stockholm, Sweden (Press Release) – Oncopeptides AB (publ) (Nasdaq Stock­holm: ONCO) to­day an­nounces that the Com­pany submits a New Drug Appli­ca­tion (NDA) to the U.S. Food and Drug Admin­istra­tion, FDA, for ac­cel­er­ated ap­prov­al of mel­flu­fen (INN mel­phalan flufenamide) in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of adult patients with mul­ti­ple myeloma whose dis­ease is re­frac­tory to at least one pro­te­a­some in­hib­i­tor, one immuno­modu­la­tory agent and one anti-CD38 mono­clonal anti­body (i.e., triple-class re­frac­tory mul­ti­ple myeloma patients).

Melflufen is the lead can­di­date com­ing out of the Oncopeptides' pro­pri­e­tary PDC-platform. The prod­uct is a first-in-class aminopeptidase-targeting …

Stamford, CT (Press Release) – Spring­Works Thera­peutics, Inc. (Nasdaq: SWTX), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on devel­op­ing life-changing med­i­cines for patients with severe rare dis­eases and can­cer, to­day an­nounced that the first patient has been dosed in a Phase 1b clin­i­cal trial eval­u­ating Spring­Works Thera­peutics’ inves­ti­ga­tional gamma secretase in­hib­i­tor, niro­gace­stat, in com­bi­na­tion with GlaxoSmithKline’s (GSK) inves­ti­ga­tional anti-B-cell maturation an­ti­gen (BCMA) anti­body-drug con­ju­gate, be­lan­ta­mab mafo­dotin, in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma. The niro­gace­stat and be­lan­ta­mab mafo­dotin com­bi­na­tion is being eval­u­ated as a sub-study in GSK’s on­go­ing DREAMM-5 plat­form trial.

Gamma secretase in­hib­ition …