AbbVie’s Imbruvica (ibrutinib) + Gazyva (obinutuzumab) Receives FDA’s Approval, First CT Free Treatment for 1L+ CLL/SLL

 AbbVie’s Imbruvica (ibrutinib) + Gazyva (obinutuzumab) Receives FDA’s Approval, First CT Free Treatment for 1L+ CLL/SLL

AbbVie’s Imbruvica (ibrutinib) + Gazyva (obinutuzumab) Receives FDA’s Approval, First CT Free Treatment for 1L+ CLL/SLL

Shots:

  • The combinational approval is based P-III iLLUMANTE (PCYC-1130) study results assessing Imbruvica + Gazyva vs chlorambucil + Gazyva in patients with 1L+ Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) aged ≥ 65 years
  • The P-III iLLUMANTE study resulted in 77% reduction in risk of progression or death and has also shown 85% reduction in progression or death of patients with high-risk disease (17p deletion/TP53 mutation, 11q deletion, or unmutated IGHV), and were presented at ASH 2018
  • Imbruvica (ibrutinib) 420mg is an oral qd therapy which inhibits Bruton’s tyrosine kinase (BTK) and has received its 10 FDA approval. The approval also includes its usage as a single agent with the results of P-III RESONATE (PCYC-1112) and RESONATE-2 (PCYC-1115, PCYC-1116) study

Click here to read full press release/ article | Ref: Abbvie | Image: Stats

Shiwani Sharma

Shiwani Sharma is a Senior Editor at PharmaShots. She has in-depth knowledge of lifesciences industry including pharma and biotech sectors. She also covers news in field of Digital Health, Medtech and regulatory approvals from the US FDA, EU, and other global regulatory bodies in the industry. Additionally, she also writes Whitepapers, analysis reports, blogs on pharma and biotech industry. She is graduate in Biotechnology. She can be contacted on shiwani@pharmashots.com

Related post