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October 29, 2021October 29, 2021 – The U.S. FDA has approved Scemblix® (asciminib) to treat adults diagnosed with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) with the T315I mutation, and in adults who have Ph+ CML-CP and have received prior treatment with at least two tyrosine kinase inhibitors (TKIs).
- Patients whose CML is Ph+ face a worse prognosis than those whose CML is Ph-. In addition, the presence of a T315I mutation in Ph+ CML-CP is associated with significantly worse treatment outcomes compared to patients who have not developed the T315I mutation.
- Scemblix offers a new mechanism of action in CML drug therapy known as a STAMP inhibitor. This provides a new treatment option for patients who have an intolerance to or whose disease is resistant to standard-of-care treatment with TKIs.
- Recommended dosing is as follows:
- Ph+ CML-CP without T315I mutation: 80mg by mouth once daily or 40mg twice daily.
- Ph+ CML-CP with T315I mutation: 200mg by mouth twice daily.
- Scemblix is manufactured by Novartis and available at a wholesale acquisition cost (WAC) of $17,900 per 60 tablets.