Otsuka and Astex Receive EC’s Approval for Inaqovi (decitabine and cedazuridine) to Treat Newly Diagnosed Acute Myeloid Leukaemia
Shots:
- The EC has approved Inaqovi (oral decitabine and cedazuridine) as monotx. for adult patients with newly diagnosed AML who are ineligible for standard induction CT. The approval was based on the P-III trial (ASCERTAIN) evaluating fixed-dose combination vs decitabine (IV) in a ratio (1:1) in 89 AML patients
- The study met its 1EPs i.e., the fixed-dose combination showed PK exposure equivalence of 99.64% to IV decitabine given at 20 mg/m2 for 5 days using a two-cycle, cross-over study design. The secondary results showed a m-OS of 7.9mos. & CR rate of 21.8% at 7.95mos. median follow up
- The safety was consistent with those anticipated for IV decitabine. The EC’s decision will be valid to EEA incl. the EU member states, Iceland, Liechtenstein & Norway
Ref: Astex | Image: Otsuka
Related News:- Roche Collaborated with Avista to Develop AAV Gene Therapy Vectors for the Treatment of Ocular Diseases
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
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.
