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CHMP backs J&Jā€™s myeloma bispecific Tecvayli, ahead of US decision

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Tecvayli (teclistamab) is an off-the-shelf bispecific antibody targeting both BCMA and CD3 which is also under review at the FDA and if approved will slot into J&J’s myeloma therapy portfolio alongside Darzalex (daratumumab) ā€“ an antibody directed at CD38 ā€“ and BCMA-targeted CAR-T therapy Carvykti (ciltacabtagene autoleucel).

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J&J gets first approval for multiple myeloma bispecific Tecvayli

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It joins a number of other BCMA-directed therapies for multiple myeloma, including GSK’s first-to-market antibody-drug conjugate Blenrep (belantamab mafodotin), Bristol-Myers Squibb/bluebird bio’s CAR-T therapy Abecma (idecabtagene vicleucel) and J&J/Legend Biotech’s CAR-T Carvykti (ciltacabtagene autoleucel).

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After a slow start for expensive CAR-T therapies, drug developers revisit oral therapies for blood cancer

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price tag of $475,000 when it was first launched in 2017 ā€“ and it becomes apparent that these may not be desirable treatment options for every patient and in every setting. Add to this the considerable cost of these medications ā€“ the first approved CAR-T, Novartisā€™ Kymriah (tisagenlecleucel), had a U.S.

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CHMP backs J&Jā€™s myeloma CAR-T therapy Carvykti

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Johnson & Johnson is in course for approval of its multiple myeloma CAR-T therapy Carvykti in the EU the next few weeks, after getting a green light from the EMA’s human medicines committee. It reckons Carvykti could eventually become a $5 billion-a-year blockbuster, if it can extend its use earlier in the treatment pathway. .”