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Home » multiple myeloma

Articles Tagged with ''multiple myeloma''

Cancer

Chordia Therapeutics’ CRD-1367799 shows antitumor efficacy in multiple myeloma

April 16, 2024
Multiple myeloma (MM) stands as the second most common hematologic malignancy. Proteasome inhibitors are effective in MM, but many patients develop resistance, which is thought to be caused by mutations in the PSMB5 gene.
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Multiple myeloma cells in the bone marrow.

FDA adcom backs MRD as new endpoint in multiple myeloma trials

April 12, 2024
By Lee Landenberger
By a unanimous 12-0 vote, the U.S. FDA’s Oncologic Drugs Advisory Committee concluded that new evidence support the use of minimal residual disease (MRD) as an accelerated approval endpoint in multiple myeloma (MM) clinical trials. The FDA will now consider the recommendation, which, if incorporated into future studies, could dramatically shorten some drug developer timelines and offer more options for treating the aggressive bone marrow cancer.
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FDA: Would a new endpoint for accelerated approvals in MM work?

April 10, 2024
By Lee Landenberger
The U.S. FDA thinks using minimal residual disease as an endpoint for accelerated approval in new therapies to treat multiple myeloma (MM) might just be an idea whose time has come. The FDA now wants to know what its Oncologic Drugs Advisory Committee thinks about it, so the agency has convened a meeting of the committee for a deep dive into the subject on April 12.
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Immuno-oncology

Hangzhou’s DXC-006 ADC shows antitumor activity in preclinical models

April 10, 2024
DXC-006 (Hangzhou DAC Biotechnology Co. Ltd.) is an antibody-drug conjugate (ADC) that targets CD56, a molecule involved in cell-cell adhesion and cell-matrix adhesion that is overexpressed in neuroblastoma, small-cell lung cancer and multiple myeloma, but less frequently expressed in normal tissues. DXC-006 consists of an anti-CD56 antibody (DXA-006) linked to the topoisomerase 1 (TOP1) inhibitor CPT-116 through a linker.
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FDA expands Legend, J&J’s Carvykti with ‘best-case’ label in MM

April 8, 2024
By Jennifer Boggs
Following the U.S. FDA’s expansion of competing BCMA-targeting CAR T therapy Abecma (idecabtagene vicleucel) to include third-line and later treatment in multiple myeloma (MM) patients, the agency cleared Carvykti (ciltacabtagene autoleucel) from Legend Biotech Corp. and Johnson & Johnson’s Janssen unit for use in MM patients as early as second-line treatment. The label, which RBC Capital Markets analyst Leonid Timashev called a “best-case scenario,” includes no notable updates to the black box warning and should help accelerate and expand Carvykti’s update in the U.S., with 2024 revenues expected to top $950 million.
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FDA widens Abecma label in MM for BMS, 2seventy

April 5, 2024
By Randy Osborne
Mixed opinions from the U.S. FDA’s Oncology Drugs Advisory Committee last month didn’t stop the agency from green-lighting an expanded label for Abecma (idecabtagene vicleucel) to include adults with relapsed or refractory multiple myeloma (r/r MM) after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody.
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Musculoskeletal

RAM-2061 shows initial preclinical efficacy for multiple myeloma-associated bone disease

April 3, 2024
About 90% of patients with multiple myeloma (MM) develop severe bone disease, known as myeloma bone disease (MBD). This occurs due to the ability of MM cells to disrupt bone homeostasis, leading to excessive bone resorption. Some current treatments are effective for treating MBD, but they are associated with undesired adverse events.
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Multiple myeloma illustration
Immuno-oncology

ORIC-533, a potent and selective CD73 inhibitor for cancer

March 26, 2024
Previous research has shown that adenosine impairs antitumor immunity, and high levels of adenosine and CD73 have been associated with poor prognosis in cancer.
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IV drips

Adcom CAR T party favors Carvykti in MM, Abecma not so much

March 15, 2024
By Randy Osborne
The U.S. FDA’s Oncology Drugs Advisory Committee, in two separate sessions, took up the matters of Carvykti (ciltacabtagene autoleucel) from Johnson & Johnson and the Bristol Myers Squibb Co. product Abecma (idecabtagene vicleucel) – specifically, whether the benefits of each CAR T therapy outweigh the risks in relapsed or refractory multiple myeloma (MM).
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Adcom to weigh CAR T benefit in myeloma against early deaths

March 13, 2024
By Mari Serebrov
There’s no denying that Johnson & Johnson’s Carvykti (ciltacabtagene autoleucel) and Bristol Myers Squibb Co.’s Abecma (idecabtagene vicleucel) show clinical benefit as they seek to move up in the line of treatment for relapsed or refractory multiple myeloma. But the question that will be put to the U.S. FDA’s Oncology Drugs Advisory Committee March 15 is whether the benefit outweighs a risk of early deaths seen with both CAR T therapies.
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