FDA Mandates "Boxed Warning" For Bristol Myers, Johnson & Johnson CAR-T-Based Blood Cancer Therapies
Portfolio Pulse from Vandana Singh
The FDA mandates boxed warnings for all CAR-T-based blood cancer therapies, including those by Bristol Myers Squibb, Johnson & Johnson, and others, due to risks of secondary cancers. Updates to labels and lifelong monitoring for secondary malignancies are required.
April 19, 2024 | 1:28 pm
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NEGATIVE IMPACT
Bristol Myers Squibb's CAR-T therapies, Abecma and Breyanzi, now require FDA-mandated boxed warnings due to secondary cancer risks.
The FDA's requirement for boxed warnings on Bristol Myers Squibb's CAR-T therapies could potentially impact the company's reputation and sales of these products, leading to a negative short-term impact on the stock.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 90
NEGATIVE IMPACT
Gilead Sciences' Yescarta, initially included in the FDA's boxed warning list for CAR-T therapies, indicates heightened regulatory scrutiny.
The inclusion of Yescarta in the FDA's boxed warning list could negatively impact Gilead Sciences' stock by potentially reducing the therapy's marketability and sales.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 90
NEGATIVE IMPACT
Johnson & Johnson's Carvykti must now include a boxed warning for secondary cancer risks as mandated by the FDA.
The imposition of boxed warnings on Johnson & Johnson's Carvykti could negatively affect the drug's market perception and sales, potentially harming JNJ's stock in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 90
NEGATIVE IMPACT
Legend Biotech, in partnership with Johnson & Johnson, faces new FDA boxed warning requirements for Carvykti due to secondary cancer risks.
As a partner in the development of Carvykti, Legend Biotech could see a negative impact on its valuation and investor sentiment due to the FDA's safety concerns, affecting its stock negatively in the short term.
CONFIDENCE 85
IMPORTANCE 70
RELEVANCE 80
NEGATIVE IMPACT
Novartis's Kymriah is subject to the FDA's new boxed warning mandate due to the risk of secondary cancers.
The requirement for a boxed warning on Novartis's Kymriah could lead to decreased sales and a tarnished brand image, negatively impacting NVS stock in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 90
NEGATIVE IMPACT
2seventy bio, in partnership with Bristol Myers Squibb on Abecma, faces new FDA boxed warning requirements due to secondary cancer risks.
The FDA's boxed warning requirement for Abecma could negatively affect 2seventy bio's stock by impacting the therapy's sales and market perception, given its partnership with Bristol Myers Squibb.
CONFIDENCE 85
IMPORTANCE 70
RELEVANCE 80