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Myeloma Research News The Web’s Daily Resource for Myeloma Research News

  • New Under-the-skin Darzalex Formulation Approved in EU
    by Joana Carvalho, PhD on June 5, 2020 at 12:00 pm

    The European Commission (EC) has approved a new under-the-skin (subcutaneous), fixed-dose formulation of Janssen’s Darzalex (daratumumab) for the treatment of adults with multiple myeloma. The approval of the new type of delivery applies to all indications for which the therapy’s original intravenous (into-the-vein) formulation is currently approved. That includes its use with newly diagnosed patients The post New Under-the-skin Darzalex Formulation Approved in EU appeared first on Myeloma Research News.

  • Sarclisa Triple Combo Approved in Europe for Advanced Myeloma Patients
    by Marisa Wexler, MS on June 3, 2020 at 12:00 pm

    The European Commission (EC) has approved Sanofi‘s Sarclisa (isatuximab), in a triple combination with Pomalyst (pomalidomide) and dexamethasone, to treat adults with relapsed or refractory multiple myeloma. The approval is specifically for those who have tried at least two previous types of treatment, to include Revlimid (lenalidomide) and a proteasome inhibitor, and experienced disease progression on the most recent therapy. It covers The post Sarclisa Triple Combo Approved in Europe for Advanced Myeloma Patients appeared first on Myeloma Research News.

  • CHMP Favors Darzalex Faspro in Treating Patients in EU
    by Steve Bryson PhD on June 1, 2020 at 12:00 pm

    Janssen‘s new under-the-skin formulation of daratumumab, called Darzalex Faspro, has been recommended for approval in Europe by the Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency, as a faster and easier alternative to treat people with multiple myeloma. The new formulation, combining daratumumab and hyaluronidase, is given to The post CHMP Favors Darzalex Faspro in Treating Patients in EU appeared first on Myeloma Research News.

  • FDA Asks for More Data on Ide-cel as Potential Multiple Myeloma Therapy
    by Joana Carvalho, PhD on May 18, 2020 at 5:00 pm

    The U.S. Food and Drug Administration (FDA) asked for more information from Bristol Myers Squibb and Bluebird Bio as it considers a request to approve their lead CAR T-cell therapy — idecabtagene vicleucel (ide-cel; bb2121) — for heavily pre-treated patients with multiple myeloma. The agency’s refusal letter requested further details on the potential therapy’s chemistry, manufacturing and control — or The post FDA Asks for More Data on Ide-cel as Potential Multiple Myeloma Therapy appeared first on Myeloma Research News.

  • Cell Protein Analysis May Predict Multiple Myeloma Response to Treatment
    by Marisa Wexler, MS on May 11, 2020 at 5:00 pm

    A new technology that measures the levels of proteins in individual cells could help to identify therapy combinations that might more effectively treat people with multiple myeloma, a study suggests. Its researchers also report that lowering levels of a particular protein on myeloma cells, MCL-1, may make them more responsive to treatments for this cancer. The The post Cell Protein Analysis May Predict Multiple Myeloma Response to Treatment appeared first on Myeloma Research News.

Myeloma Research News The Web’s Daily Resource for Myeloma Research News

  • New Under-the-skin Darzalex Formulation Approved in EU
    by Joana Carvalho, PhD on June 5, 2020 at 12:00 pm

    The European Commission (EC) has approved a new under-the-skin (subcutaneous), fixed-dose formulation of Janssen’s Darzalex (daratumumab) for the treatment of adults with multiple myeloma. The approval of the new type of delivery applies to all indications for which the therapy’s original intravenous (into-the-vein) formulation is currently approved. That includes its use with newly diagnosed patients The post New Under-the-skin Darzalex Formulation Approved in EU appeared first on Myeloma Research News.

  • Sarclisa Triple Combo Approved in Europe for Advanced Myeloma Patients
    by Marisa Wexler, MS on June 3, 2020 at 12:00 pm

    The European Commission (EC) has approved Sanofi‘s Sarclisa (isatuximab), in a triple combination with Pomalyst (pomalidomide) and dexamethasone, to treat adults with relapsed or refractory multiple myeloma. The approval is specifically for those who have tried at least two previous types of treatment, to include Revlimid (lenalidomide) and a proteasome inhibitor, and experienced disease progression on the most recent therapy. It covers The post Sarclisa Triple Combo Approved in Europe for Advanced Myeloma Patients appeared first on Myeloma Research News.

  • CHMP Favors Darzalex Faspro in Treating Patients in EU
    by Steve Bryson PhD on June 1, 2020 at 12:00 pm

    Janssen‘s new under-the-skin formulation of daratumumab, called Darzalex Faspro, has been recommended for approval in Europe by the Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency, as a faster and easier alternative to treat people with multiple myeloma. The new formulation, combining daratumumab and hyaluronidase, is given to The post CHMP Favors Darzalex Faspro in Treating Patients in EU appeared first on Myeloma Research News.

  • FDA Asks for More Data on Ide-cel as Potential Multiple Myeloma Therapy
    by Joana Carvalho, PhD on May 18, 2020 at 5:00 pm

    The U.S. Food and Drug Administration (FDA) asked for more information from Bristol Myers Squibb and Bluebird Bio as it considers a request to approve their lead CAR T-cell therapy — idecabtagene vicleucel (ide-cel; bb2121) — for heavily pre-treated patients with multiple myeloma. The agency’s refusal letter requested further details on the potential therapy’s chemistry, manufacturing and control — or The post FDA Asks for More Data on Ide-cel as Potential Multiple Myeloma Therapy appeared first on Myeloma Research News.

  • Cell Protein Analysis May Predict Multiple Myeloma Response to Treatment
    by Marisa Wexler, MS on May 11, 2020 at 5:00 pm

    A new technology that measures the levels of proteins in individual cells could help to identify therapy combinations that might more effectively treat people with multiple myeloma, a study suggests. Its researchers also report that lowering levels of a particular protein on myeloma cells, MCL-1, may make them more responsive to treatments for this cancer. The The post Cell Protein Analysis May Predict Multiple Myeloma Response to Treatment appeared first on Myeloma Research News.