Remove clinical multiple-myeloma
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FDA flags early deaths in CAR-T myeloma trials for J&J and Legend’s Carvykti, Bristol Myers’ Abecma

Fierce Pharma

The FDA has raised concerns about early clinical trial deaths as part of two applications that aim to move the CAR-T therapies Carvykti and Abecma into earlier lines of treatment for multiple myelo | Ahead of an important advisory committee meeting, the FDA has raised concerns about early trial deaths for multiple myeloma cell therapies.

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Fierce Pharma Asia—BIO-WuXi break-off; Takeda's site closure; FDA's concern over Carvykti

Fierce Pharma

The FDA questioned whether Carvykti should be approved in an earlier line of multiple myeloma after noticing an early detriment to patient survival in a clinical trial. Takeda will shut down a gene therapy manufacturing and R&D facility in Austria. And more.

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ASCO Recap: Multiple Myeloma Moves, ADC Advances & Brain Cancer Progress

MedCity News

During the annual meeting of the American Society of Clinical Oncology, a cell therapy posted clinical data during that could broaden its use in multiple myeloma.

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Preventative approach could reduce immunotherapy side effects

European Pharmaceutical Review

New research from the US indicates that a prophylactic treatment before immunotherapy can significantly reduce the rate of cytokine release syndrome (CRS) in multiple myeloma patients. The drug tocilizumab for example, has been used historically to treat CRS from immunotherapies.

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Multiple myeloma bispecific antibody granted accelerated approval

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has granted accelerated approval of TALVEY (talquetamab-tgvs) to treat multiple myeloma. Multiple myeloma MonumenTAL-1 study In the dose-escalation MonumenTAL-1 study, which incorporated Phase I and Phase II , over 300 patients were enrolled. A median duration of follow-up of 10.4

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BCMA-GPRC5D CAR-T Cells by Guangzhou Bio-gene Technology for Relapsed Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

BCMA-GPRC5D CAR-T Cells is under clinical development by Guangzhou Bio-gene Technology and currently in Phase II for Relapsed Multiple Myeloma.

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CHMP meeting highlights: February 2024

European Pharmaceutical Review

Clinical data showed approximately 60 percent reductions in plasma NfL concentrations in patients given Qalsody compared to placebo. After 12 weeks, patients treated with danicopan had a clinically-relevant increase in haemoglobin (an average of 2.35 This indicated reduced neuronal injury, EMA noted.