Xarelto Receives Expanded Indication for Peripheral Artery Disease
August 24, 2021Skytrofa Approved for Pediatric Growth Hormone Deficiency
August 25, 2021August 25, 2021 – The U.S. FDA has granted a new indication to Tibsovo® (ivosidenib tablets) for use in adults who have previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation as detected by an FDA-approved test.
- Cholangiocarcinoma is a rare and aggressive cancer that originates in the bile ducts. IDH1 mutations are associated with the development and growth of cancer.
- Tibsovo is the first and only FDA-approved drug for this indication.
- It is also indicated to treat adults with confirmed IDH1 mutation who have:
- Newly diagnosed acute myeloid leukemia (AML) and are at least 75 years old or have comorbidities that preclude use of intensive induction chemotherapy; or
- Relapsed or refractory AML.
- Under the recommended dosing, 500mg (two 250mg tablets) of Tibsovo should be taken by mouth once daily until disease progression or unacceptable toxicity occur. High-fat meals should be avoided if the medication is taken with food.
- Tibsovo, which is manufactured by Servier, first received FDA approval in 2018.