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Servier’s Tibsovo (ivosidenib) Receives the US FDA's Approval for the Treatment of IDH1-mutated Acute Myeloid Leukemia

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Servier’s Tibsovo (ivosidenib) Receives the US FDA's Approval for the Treatment of IDH1-mutated Acute Myeloid Leukemia

Servier’s Tibsovo (ivosidenib) Receives the US FDA's Approval for the Treatment of IDH1-mutated Acute Myeloid Leukemia

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  • The approval was based on the P-III (AGILE) study evaluating Tibovo + azacitidine vs PBO + azacitidine in adults (≥75yrs.) with formerly untreated IDH1-mutated AML incl. those who are not candidates for intensive CT or have comorbidities that preclude the use of intensive induction CT
  • The results showed a significant improvement in EFS (HR=0.35), OS (HR=0.44) & a three-fold improvement in mOS of Tibsovo + azacitidine (24mos.) vs PBO + azacitidine (7.9mos)
  • Tibsovo (500mg, oral, QD) was approved in the US as a monothx. for IDH1-mutant r/r AML & IDH1-mutant AML. The company has launched ServierONE Patient Support Services to help patients who are prescribed Tibsovo/other Servier products, navigate their cancer journey

Ref: PRNewswire | Image: Servier

Click here to­ read the full press release 

Neha

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.

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