Logo

AbbVie’s Imbruvica (ibrutinib) Receives the US FDA’s Approval for Chronic Graft Versus Host Disease in Pediatric Patients Aged ≥1 Year

Share this

AbbVie’s Imbruvica (ibrutinib) Receives the US FDA’s Approval for Chronic Graft Versus Host Disease in Pediatric Patients Aged ≥1 Year

Shots:

  • The US FDA has approved Imbruvica for cGVHD in pediatric patients aged ≥1yr. who required additional therapy after failure of ≥1 line of systemic therapy. The therapy is jointly developed & commercialized by Janssen & Pharmacyclics
  • The approval was based on the P-I/II (iMAGINE) trial evaluating Imbruvica (in 47 pediatric & young adult patients aged 1yr. to ≤22yrs. with cGVHD which showed ORR (60%) @25wk. in patients aged 13yrs., m-DoR was 5.3mos. The safety was consistent with the established profile for Imbruvica, ARs consistent with those observed in cGVHD
  • Imbruvica is a BTK inhibitor & was approved for a pediatric patient population. The therapy marks the first approved treatment option for children ≤12yrs. with cGVHD

Ref: PRNewswire | Image: AbbVie

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions