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Home » multiple myeloma

Articles Tagged with ''multiple myeloma''

EMA icons

One trial, two regulators, two opinions on Oncopeptides drug

Sep. 14, 2023
By Mari Serebrov
Supporting their conclusions with data from the same phase III study, the EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for extending the use of Oncopeptides AB’s Pepaxti (melflufen) to earlier lines of treating relapsed, refractory multiple myeloma even as the FDA dug in its heels about withdrawing the drug from the U.S. market.
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Aphexda

Biolinerx’s stem cell mobilizer approved for MM patients

Sep. 11, 2023
By Lee Landenberger
With the U.S. FDA’s approval of Biolinerx Ltd.’s stem cell mobilization agent Aphexda (motixafortide) for treating multiple myeloma (MM) patients, the company is prepping for a launch in the next two or three weeks.
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FDA Approved stamp

FDA on a roll: Pfizer’s Elrexfio latest bispecific antibody for r/r MM to win approval

Aug. 15, 2023
By Caroline Richards
Less than a week after approving Johnson & Johnson’s bispecific antibody, Talvey (talquetamab-tgvs), for relapsed or refractory multiple myeloma (r/r MM) under accelerated review, the U.S. FDA has followed suit with Pfizer Inc.’s equivalent, Elrexfio (elranatamab-bcmm). The accelerated clearance of Elrexfio – a B-cell maturation antigen (BCMA) bispecific antibody that targets BCMA on myeloma cells and the CD3 receptor on T cells – covers it for adult patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
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Multiple myeloma illustration

Oricell clears IND hurdle for homegrown CAR T in China

Aug. 15, 2023
By Marian (YoonJee) Chu
Oricell Therapeutics Co. Ltd. has become the latest Chinese biotech to advance an independently developed CAR T therapy, announcing Aug. 10 that China’s regulatory body gave IND approval for Oricar-017. Oricar-017 is the Shanghai-based biotech’s GPRC5D-directed CAR T therapy developed to treat patients with relapsed or refractory multiple myeloma.
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A bridging just far enough: Arcellx’s phase II is back on track

Aug. 15, 2023
By Lee Landenberger
An updated trial protocol providing expanded bridging therapies are part of the agreement between the U.S. FDA and Arcellx Inc. that allows the lifting of the partial clinical hold on the company’s pivotal phase II study of CAR T-cell therapy CART-ddBCMA in multiple myeloma (MM).
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Multiple myeloma illustration

Oricell clears IND hurdle for homegrown CAR T in China

Aug. 11, 2023
By Marian (YoonJee) Chu
Oricell Therapeutics Co. Ltd. has become the latest Chinese biotech to advance an independently developed CAR T therapy, announcing Aug. 10 that China’s regulatory body gave IND approval for Oricar-017. Oricar-017 is the Shanghai-based biotech’s GPRC5D-directed CAR T therapy developed to treat patients with relapsed or refractory multiple myeloma.
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FDA approved icons and medical professional

Class, group, member: J&J gets (bi)specific in r/r MM with Talvey approval

Aug. 10, 2023
By Randy Osborne
The accelerated clearance won by Johnson & Johnson (J&J) from the U.S. FDA for Talvey (talquetamab-tgvs) for relapsed or refractory multiple myeloma (r/r MM) in adults brings to the market the bispecific antibody that takes aim at G protein-coupled receptor class C group 5 member D, a target of interest to other developers as well.
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Diagnostics

New radiolabeled bioconjugate for CD38 imaging in multiple myeloma

July 13, 2023
Researchers from Washington University in St. Louis and affiliated organizations have provided details on the discovery and preclinical evaluation of [64Cu]NODAGA-PEG4-SL-022-GGS, a novel small peptide imaging agent for evaluating CD38 expression.
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Antibody
Newco news

Haemalogix’s Kappamab hits endpoints in phase IIb myeloma trial

July 11, 2023
By Tamra Sami
Haemalogix Ltd.’s monoclonal antibody Kappamab met all primary endpoints in a phase IIb trial that combined the MAb with lenalidomide and dexamethasone in kappa-type multiple myeloma patients who had relapsed or become refractory to other treatments.
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Multiple myeloma illustration

Innovent-Iaso first to finish line in China for multiple myeloma CAR T therapy

July 11, 2023
By Marian (YoonJee) Chu
Nanjing Iaso Biotherapeutics Co. Ltd. and Innovent Biologics Inc. said on July 2 they gained China NMPA approval for the first self-developed and in-house manufactured CAR T therapy Fucaso (equecabtagene autoleucel) to treat relapsed or refractory multiple myeloma.
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