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March 29, 2019March 29, 2019

FDA Application Submitted for Darzalex Combo Therapy to Treat Certain Multiple Myeloma Patients

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An application has been submitted seeking U.S. approval of Darzalex (daratumumab) in combination with standard pre-transplant therapy to treat newly diagnosed multiple myeloma patients who are eligible for a stem cell ... Read more

March 27, 2019

FDA Puts Partial Hold on Venetoclax’s Multiple Myeloma Trials

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The U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on venetoclax’s multiple myeloma trials after new safety concerns were raised during a review of the ... Read more

March 25, 2019

Phase 1/2 Trial of Tinostamustine Recruiting Patients with Myeloma, Other Blood Cancers

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The expansion part of a Phase 1/2 clinical trial testing tinostamustine in relapsed or refractory blood cancers has begun treating the first patient. The trial (NCT02576496), conducted by Mundipharma EDO ... Read more

March 22, 2019

Darzalex Triple Combo Approved in England for Difficult-to-treat Multiple Myeloma

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A triple combination of Darzalex (daratumumab), Velcade (bortezomib), and dexamethasone will be available on the National Health Service (NHS) in England for the treatment of relapsed or refractory multiple ... Read more

March 20, 2019March 20, 2019

Janssen Seeks Final FDA Approval for Darzalex Combo Therapy for Newly Diagnosed Multiple Myeloma

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Janssen has is seeking approval from the U.S. Food and Drug Administration (FDA) for Darzalex (daratumumab) — in combination with standard Revlimid (lenalidomide) and dexamethasone — as a treatment for newly diagnosed multiple myeloma patients ... Read more

March 18, 2019

NantKwest, ProMab Partner to Develop Natural Killer Cell Therapy for Multiple Myeloma, Other Blood Cancers

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NantKwest and ProMab Biotechnologies are collaborating to develop a novel immunotherapy for multiple myeloma using natural killer (NK) cells that target the B-cell maturation antigen, or BCMA. The therapy, called ... Read more

March 15, 2019

Kyprolis Combo Yields Positive Results as Initial Treatment for Multiple Myeloma

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A combination of Kyprolis (carfilzomib) and dexamethasone, already approved for relapsed and refractory multiple myeloma, may also be effective and safe as a first-line treatment for newly diagnosed patients, according ... Read more

March 14, 2019

CARsgen to Begin CT053 Clinical Testing in China for Heavily Treated Myeloma Patients

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CT053, one of CARsgen Therapeutics‘ lead CAR T-cell therapies, soon will begin clinical testing in China for the treatment of patients with relapsed or refractory multiple myeloma, after the Chinese ... Read more

March 11, 2019

Under-the-skin Formulation as Effective as Intravenous Darzalex for Myeloma Patients, Study Says

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An under-the-skin injection of daratumumab is as effective as its intravenous formulation, Darzalex (daratumumab), at reducing tumor burden in multiple myeloma patients, a Phase 3 clinical trial shows. The new ... Read more

March 8, 2019

FDA Raises Concerns on Safety, Tolerability of Potential Myeloma Therapy Selinexor

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The U.S. Food and Drug Administration has raised concerns in its newly released briefing materials over the safety and tolerability of Karyopharm Therapeutics‘ lead compound selinexor, creating a potential stumbling block on its path ... Read more

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