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Update: FDA Staff Raises Concerns Over Cancer Cell Therapies of Johnson & Johnson, Bristol Myers Squibb
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Update: FDA Staff Raises Concerns Over Cancer Cell Therapies of Johnson & Johnson, Bristol Myers Squibb
Mar 13, 2024 10:17 AM

12:57 PM EDT, 03/13/2024 (MT Newswires) -- (Updates with Johnson & Johnson's ( JNJ ) statement in the third paragraph.)

The US Food and Drug Administration's staff on Wednesday raised concerns about whether the cancer cell therapies of Johnson & Johnson ( JNJ ) and Bristol Myers Squibb ( BMY ) would benefit adult patients with myeloma, a type of blood cancer, due to higher rate of early deaths in their respective late-stage trials, according to briefing documents.

The health regulator's oncologic drugs advisory committee will discuss their concerns over Janssen's Carvykti and Bristol Myers' Abecma on Friday.

"We are confident in the data from the phase 3 Cartitude-4 study and look forward to reviewing survival and safety data with the FDA Oncologic Drugs Advisory Committee," Johnson & Johnson ( JNJ ) said in an email to MT Newswires. "We remain confident that the overall benefit-risk profile of Carvykti remains favorable in the treatment of patients with relapsed/refractory multiple myeloma."

Bristol Myers did not immediately respond to a request for comment by MT Newswires.

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