1. Pink Sheet
  2. >>Product Reviews
  3. >>Approvals

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 at least one prior line of therapy, including a proteasome...

Key Takeaways

  • J&J/Legend Biotech’s BCMA-directed CAR-T therapy Carvykti added a new claim on 5 April for relapsed and refractory multiple myeloma patients who have received at least one...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Approvals

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

Autolus’s Aucatzyl And GSK’s Blenrep Among 10 New Drugs To Get EMA Nod

 
• By Vibha Sharma

The European Medicines Agency has OKd 10 new medicines for EU-wide approval, including a CAR-T therapy for treating acute lymphoblastic leukemia. Two drugs were, however, rejected.

EU Authorization Before US? Biologics Manufacturing Is Likely To Blame

 
• By Bridget Silverman

In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.

More from Product Reviews

US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role

 
• By Sue Sutter

By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.