Articles tagged with: GSK2857916

Press Releases»

[ by | Aug 26, 2020 2:06 pm | Comments Off ]
  • BLENREP is the first anti-BCMA (B-cell maturation an­ti­gen) ther­apy ap­prov­ed in the Euro­pean Union
  • Marketing autho­ri­sa­tion follows the recent US ap­prov­al of BLEN­REP

European Commission Approves Blenrep (Belantamab Mafodotin) For The Treatment Of Patients With Relapsed And Refractory Multiple Myeloma London, United Kingdom (Press Release) – GlaxoSmithKline plc to­day an­nounced the Euro­pean Com­mis­sion has granted con­di­tional mar­ket­ing autho­ri­sa­tion for BLEN­REP (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. BLEN­REP is a first-in-class humanised anti-BCMA (B-cell maturation an­ti­gen) treat­ment for these patients whose …

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Press Releases»

[ by | Aug 5, 2020 9:08 pm | Comments Off ]
  • BLENREP is a first-in-class anti-BCMA (B-cell maturation an­ti­gen) ther­apy for patients whose dis­ease has progressed de­spite prior treat­ment with an immuno­modu­la­tory agent, pro­te­a­some in­hib­i­tor and anti-CD38 anti­body
  • BLENREP is the fifth major med­i­cine ap­prov­al for GSK in 2020

FDA Approves GSK’s Blenrep (Belantamab Mafodotin-blmf) For The Treatment Of Patients With Relapsed Or Refractory Multiple Myeloma London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) an­nounced the US Food and Drug Admin­istra­tion (FDA) has approved BLEN­REP (belantamab mafo­dotin-blmf) as a mono­therapy treat­ment for adult patients with re­lapsed or re­frac­tory mul­ti­ple myeloma who have re­ceived at least four prior ther­a­pies in­clud­ing an anti-CD38 mono­clonal anti­body, a pro­te­a­some in­hib­i­tor and an immuno­modu­la­tory agent. This in­di­ca­tion is approved under ac­cel­er­ated ap­prov­al based on re­sponse rate. Continued ap­prov­al for this in­di­ca­tion may be con­tin­gent upon veri­fi­ca­tion and description of clin­i­cal ben­e­fit in …

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Press Releases»

[ by | Jul 24, 2020 5:17 am | Comments Off ]
GSK Receives Positive CHMP Opinion Recommending Approval Of Belantamab Mafodotin For The Treatment Of Relapsed And Refractory Multiple Myeloma

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 …

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Press Releases»

[ by | Jul 14, 2020 4:31 pm | Comments Off ]
  • 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

GSK Announces FDA Advisory Committee Votes In Favour Of Positive Benefit / Risk Profile For Belantamab Mafodotin For Patients With 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 …

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Press Releases»

[ by | Jun 22, 2020 6:30 am | Comments Off ]
SpringWorks Therapeutics Announces Dosing Of First Patient In Phase 1b Combination Study Evaluating Nirogacestat And GlaxoSmithKline’s Belantamab Mafodotin For The Treatment Of Relapsed Or Refractory Multiple Myeloma

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 …

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Press Releases»

[ by | Jun 19, 2020 10:22 am | Comments Off ]
GSK Announces FDA Advisory Committee Meeting To Review Belantamab Mafodotin For The Treatment Of Patients With Relapsed / Refractory Multiple Myeloma

London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) to­day an­nounced the US Food and Drug Admin­istra­tion (FDA) will convene a meeting of the Oncologic Drugs Advisory Com­mit­tee (ODAC) to re­view data sup­port­ing the com­pany’s Biologics License Appli­ca­tion (BLA) for be­lan­ta­mab mafo­dotin for the poten­tial treat­ment of 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. The ODAC will meet virtually on 14 July 2020.

Dr Axel Hoos, Senior Vice Pres­i­dent and Head of Oncology …

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Press Releases»

[ by | Feb 3, 2020 4:00 am | Comments Off ]
  • Be­lan­ta­mab mafo­dotin ac­cepted for ac­cel­er­ated assess­ment by the EMA's Com­mit­tee for Human Medicinal Products (CHMP)
  • Submission based on data from the pivotal DREAMM-2 study of immuno­con­ju­gate targeting B-cell maturation an­ti­gen (BCMA) recently pub­lished in The Lancet Oncology

GSK Announces European Medicines Agency (EMA) Accepted Marketing Authorisation Application For Belantamab Mafodotin For The Treatment Of Relapsed Or Refractory Multiple Myeloma London, United Kingom (Press Release) – GlaxoSmithKline plc to­day an­nounced that the Euro­pean Medicines Agency (EMA) val­i­dated the mar­ket­ing authori­sa­tion appli­ca­tion (MAA) for be­lan­ta­mab mafo­dotin for the treat­ment of patients with re­lapsed or re­frac­tory mul­ti­ple myeloma whose prior ther­apy in­cluded an immuno­modu­la­tory agent, a pro­te­a­some in­hib­i­tor and an anti-CD38 anti­body. Be­lan­ta­mab mafo­dotin was ac­cepted for ac­cel­er­ated assess­ment by the EMA's Com­mit­tee for Human Medicinal Products (CHMP).

Accelerated assess­ment is granted if the CHMP de­ter­mines the treat­ment is of major interest from a pub­lic health per­spec­tive …

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