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Bristol-Myers Squibb Gets FDA Approval to Streamline Patient Monitoring, Risk Mitigation for Cancer Therapies
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Bristol-Myers Squibb Gets FDA Approval to Streamline Patient Monitoring, Risk Mitigation for Cancer Therapies
Jun 27, 2025 1:52 AM

04:32 AM EDT, 06/27/2025 (MT Newswires) -- Bristol-Myers Squibb ( BMY ) said late Thursday it received regulatory approval to streamline patient monitoring and eliminate the risk evaluation and mitigation strategy programs for its CAR T-cell therapies targeting large B-cell lymphoma and multiple myeloma.

The changes approved by the US Food and Drug Administration aim to ease logistical burdens and expand access to cell therapy, currently reaching only 20% of eligible patients, the company said.

Across both T-cell therapies, Breyanzi and Abecma, the company said the FDA has approved the reduction or removal of specific patient monitoring requirements. These include lowering driving restrictions post-treatment to two weeks, from eight. The proximity-to-care requirements were halved to two weeks.

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