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FDA Refusal to File letter for Idecabtagene Vicleucel (ide-cel, bb2121) for the treatment of myeloma patients

  Bristol Myers Squibb (BMS) and bluebird bio, Inc have 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 myeloma, which was submitted in March 2020.

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MPE AGM 2020 webinar series

As part of the educational programme planned to replace the Masterclass included in the MPE Annual General Meeting (AGM) 2020, which was cancelled due to the outbreak of the coronavirus infection, MPE is organising a Webinars series.

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European Commission approves elotuzumab plus pomalidomide and dexamethasone for relapsed and refractory myeloma

  European Commission (EC) has approved elotuzumab  –marketed under the brand Empliciti by Bristol-Myers Squibb (BMS)– plus pomalidomide and low-dose dexamethasone (EPd) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI), and have demonstrated disease progression on…

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Takeda announces discontinuation of the phase 3 clinical trial TOURMALINE-AL1 in AL amyloidosis

  The pharmaceutical company Takeda announced that the Phase 3 TOURMALINE-AL1 clinical trial in patients with relapsed or refractory AL amyloidosis did not meet the first of two primary endpoints. Treatment with ixazomib in combination with dexamethasone did not demonstrate a significant improvement in overall hematologic response compared to physician’s choice of standard of care…

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