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    Penn State-Themed Restaurant and Entertainment Spot Happy Valley Live Set to Open in State College – StateCollege.com

    Penn State-Themed Restaurant and Entertainment Spot Happy Valley Live Set to Open in State College – StateCollege.com

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    Steampunk Metal Oval Technology Sense Sunglasses Personality Handmade Chain Multicolor Sunglasses UV400 – The San Joaquin Valley Sun

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    Penn State-Themed Restaurant and Entertainment Spot Happy Valley Live Set to Open in State College – StateCollege.com

    Penn State-Themed Restaurant and Entertainment Spot Happy Valley Live Set to Open in State College – StateCollege.com

    The Police Made Chart History With This 1979 Hit Nearly 50 Years Ago – Yahoo

    How The Police Changed Music Forever with Their Iconic 1979 Hit Nearly 50 Years Ago

    Good Deed Entertainment Acquires Worldwide Rights To Liza Mandelup’s Documentary ‘Caterpillar’ – Deadline

    Good Deed Entertainment Lands Global Rights to Liza Mandelup’s Captivating Documentary ‘Caterpillar

    Danielle Fishel Explains Why Being on “DWTS” Makes Her Feel ‘Like It’s 1994 Again’ Filming “Boy Meets World” (Exclusive) – Yahoo

    Danielle Fishel Explains Why Being on “DWTS” Makes Her Feel ‘Like It’s 1994 Again’ Filming “Boy Meets World” (Exclusive) – Yahoo

    Jussie Smollett Claims He Was ‘Disrespected’ on the ‘Special Forces’ Season Premiere – Yahoo

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    TicketSmarter Fall Entertainment Guide – Eastern Illinois University Athletics

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    Cracking the Code: Why China’s Economic Challenges Aren’t Shaking Markets, Unlike America’s” – Bloomberg

    Trump’s Narrow Window to Spread the Truth About Harris

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    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

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    PAP Boss to Niger Delta Youths, Stay Away from the Protest

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    Steampunk Metal Oval Technology Sense Sunglasses Personality Handmade Chain Multicolor Sunglasses UV400 – The San Joaquin Valley Sun

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Abecma Approved for Earlier Lines in R/R Multiple Myeloma

April 9, 2024
in Health
Abecma Approved for Earlier Lines in R/R Multiple Myeloma
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The US Food and Drug Administration (FDA) has approved idecabtagene vicleucel (ide-cel) (Abecma, Bristol-Myers Squibb/2seventy bio) for adults with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. 

The approval expands the chimeric antigen receptor (CAR) T-cell therapy’s indications to earlier lines of treatment after exposure to these other main therapy classes, Bristol-Myers Squibb said in a press release. 

Approval was based on the KarMMa-3 trial, in which 254 patients were randomly assigned to ide-cel and 132 to investigators’ choice of standard regimens, consisting of combinations of daratumumab, dexamethasone, and other agents. 

After a median follow-up of 15.9 months, median progression-free survival was three times higher in the ide-cel arm: 13.3 months with the CAR T-cell therapy vs 4.4 months with standard treatment. Overall, 39% of patients on ide-cel had a complete response vs 5% on standard regimens. 

The approval also includes a new recommended dose range of 300-510 x 106 CAR-positive T cells. 

Ide-cel carries a black box warning for cytokine release syndrome, neurologic toxicities, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, prolonged cytopenia, and secondary hematologic cancers. 

In trials, cytokine release syndrome occurred in 89% (310 of 349) of patients in the KarMMa-3 and KarMMa studies, which included grade 3 syndrome in in 7% (23 of 349) and fatal cases in 0.9% (three of 349) of patients.

A one-time treatment is over $500,000, according to drugs.com.

M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: [email protected]. 

>>> Read full article>>>
Copyright for syndicated content belongs to the linked Source : Medscape – https://www.medscape.com/viewarticle/abecma-approved-earlier-lines-relapsed-refractory-multiple-2024a10006no

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