Remove clinical multiple-myeloma
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FDA clears IND for Gracell Biotechnologies’ phase 1 clinical trial for multiple myeloma treatment

Pharmafile

Gracell Biotechnologies has announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application, which allows them to initiate a phase 1 trial of GC012F in the US for the early-line treatment of multiple myeloma (ELMM).

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Elranatamab provides durable clinical response in relapsed multiple myeloma

Hospital Pharmacy Europe

Use of elranatamab resulted in a durable clinical and molecular response in patients with relapsed or refractory multiple myeloma. Elranatamab clinical response. The post Elranatamab provides durable clinical response in relapsed multiple myeloma appeared first on Hospital Pharmacy Europe.

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Minimizing Terms in Multiple Myeloma Clinical Trials May Inaccurately Reflect Tolerability, Rates of AEs

Pharmacy Times

The study authors suggest that future research should instead emphasize event rates and patient-reported outcomes to better evaluate the tolerability and frequency of AEs.

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STAT+: FDA advisers back CAR-T therapies in blood cancer, despite safety concerns

STAT

The group voted 11-0 that the benefits of Carvykti, a CAR-T medicine from Johnson & Johnson and Legend Biotech, outweighed its risk for patients with multiple myeloma whose disease has persisted despite initial treatment. In clinical trials, each drug proved to significantly delay disease progression compared to standard therapy.

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Assessing Clinical Trial Efficacy vs Real-World Effectiveness in the Management of Multiple Myeloma

Pharmacy Times

There is a significant efficacy-effectiveness gap in standard-of-care regimens.

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FDA Accepts Priority Review for Linvoseltamab to Treat Adult Patients With R/R MM

Pharmacy Times

Currently, the safety and efficacy of linvoseltamab in adult patients with relapsed or refractory multiple myeloma is being compared to elotuzumab, pomalidomide, and dexamethasone in a phase 3 clinical trial.

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Cilta-cel approved by EC as second-line R/R multiple myeloma treatment

Hospital Pharmacy Europe

A type II variation of ciltacabtagene autoleucel (cilta-cel; brand name Carvykti) has been approved by the European Commission (EC) for use in the treatment of eligible patients with multiple myeloma, its manufacturer Janssen has announced. Data from the study were previously published in the New England Journal of Medicine.