FDA Adcomm Favors Expanded Use Of Johnson & Johnson, Bristol Myers' CAR-T Therapies For Type Of Blood Cancer
Portfolio Pulse from Vandana Singh
The FDA's ODAC has recommended expanded use of Bristol Myers Squibb & Co and 2seventy bio Inc's Abecma for blood cancer, and Johnson & Johnson/Legend Biotech Corporation's Carvykti, also for blood cancer. Both recommendations are based on positive Phase 3 study results. The FDA is reviewing supplemental Biologics License Applications for both therapies, with decisions pending. Abecma has already received approval in Japan and Switzerland, and a positive opinion in Europe. Competition among CAR-T therapies, including from bispecifics, is noted.
March 18, 2024 | 2:16 pm
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POSITIVE IMPACT
Bristol Myers Squibb's Abecma, developed with 2seventy bio, recommended by FDA's ODAC for expanded use in blood cancer treatment. Positive Phase 3 results and international approvals highlight its potential.
The positive recommendation from FDA's ODAC for expanded use of Abecma, based on strong Phase 3 results and international approvals, suggests potential market growth for Bristol Myers Squibb. However, competition from other CAR-T therapies may limit market share.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 90
POSITIVE IMPACT
Johnson & Johnson's Carvykti, developed with Legend Biotech, unanimously recommended by FDA's ODAC for expanded use in second-line multiple myeloma treatment.
The unanimous recommendation from FDA's ODAC for Johnson & Johnson's Carvykti, based on the CARTITUDE-4 study, suggests a favorable outlook for approval and market potential, enhancing JNJ's position in the CAR-T therapy market.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 90
POSITIVE IMPACT
Legend Biotech's collaboration with Johnson & Johnson on Carvykti receives unanimous FDA ODAC recommendation for expanded use in blood cancer treatment.
The unanimous FDA ODAC recommendation for Carvykti, developed by Legend Biotech and Johnson & Johnson, underscores the therapy's strong potential and positive impact on Legend Biotech's market presence.
CONFIDENCE 80
IMPORTANCE 75
RELEVANCE 80
POSITIVE IMPACT
2seventy bio Inc's collaboration with Bristol Myers Squibb on Abecma receives positive FDA ODAC recommendation for expanded use in blood cancer treatment.
The collaboration between 2seventy bio and Bristol Myers Squibb on Abecma, receiving a positive nod from FDA's ODAC, indicates a strong potential for market growth and increased visibility for 2seventy bio.
CONFIDENCE 80
IMPORTANCE 75
RELEVANCE 80