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J&J’s Carvykti Claims Broadest CAR-T Label In Multiple Myeloma

 
• By Bridget Silverman

The second-line indication comes with safety labeling recently approved for BCMA-targeted CAR-T competitor Abecma, particularly around increased early mortality and secondary malignancies.

multiple myeloma
Carvykti can be used in an earlier line of therapy than Bristol Myers Squibb/2seventy bio’s rival CAR-T Abecma. • Source: Shutterstock

Johnson & Johnson/Legend Biotech Corp.’s Carvykti (ciltacabtagene autoleucel) leapfrogged its multiple myeloma rival Abecma (idecabtagene vicleucel) with a new second-line multiple myeloma indication just one day after the US Food and Drug Administration cleared the Bristol Myers Squibb Company/2seventy Bio, Inc. therapy for third-line and later use.

The FDA approved Carvykti late 5 April for treatment of adults with relapsed or refractory multiple myeloma who have received...

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More from Approvals

EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
• By Eliza Slawther and Neena Brizmohun

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 
• By Neena Brizmohun

The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.

EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 
• By Eliza Slawther and Sarah Karlin-Smith

The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.

Business Background Of New CDER Director George Tidmarsh

 
• By Bridget Silverman

George Tidmarsh has extensive experience in the biopharmaceutical industry and led several drugs to FDA approval.

More from Product Reviews

Blenrep Review Highlights US FDA Oncology Trial Site Selection, Comparator Issues

 
• By Sue Sutter

The FDA will take a hard line on trial design and site selection to ensure applicability to the US, Oncology Center of Excellence Director Richard Pazdur said during a meeting on GSK's Blenrep.

EMA Poised To Decide On Fate Of Lilly’s Kisunla And PharmaMar’s Aplidin In EU

 
• By Vibha Sharma

Eli Lilly and PharmaMar were set to make their case before the European Medicines Agency this week as part of re-examination procedures for their respective drugs Kisunla and Aplidin.

Complete Response Letter Trio Raises Prospect Of Tidal Shift In Regenerative Medicine Regulation

 
• By Bridget Silverman

Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.