- The P-II OPTIC study involves assessing three initial doses of Iclusig (15/30/45 mg) in 283 patients with CML in CF, or who had documented history of the presence of the T315I mutation after receiving any number of previous TKIs
- With an average follow-up of~ 21 mos., the interim analysis showed that maximum BCR- ABL1 ≤1% in 12mos.achieved in 45mg/ day (38.7%), and responses were maintained with 15 mg / day, 75% patients with 45mg & 88% with 30mg were able to maintain BCR- ABL1 ≤1% for up to 2yrs.
- Iclusig is a kinase inhibitor directed mainly to the protein BCR-ABL1, thus inhibits the activity of BCR-ABL1 and its mutations. The company will utilize these data to file sNDA to the US FDA for the therapy
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