Takeda Announces U.S. FDA Approval of Supplemental New Drug Application (sNDA) for ICLUSIG® (ponatinib) in Adult Patients with Newly Diagnosed Ph+ ALL [Yahoo! Finance]
Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of) (TAK)
Company Research
Source: Yahoo! Finance
- First FDA Approval in Ph+ ALL Based on Novel Primary Endpoint of Minimal Residual Disease (MRD)-negative Complete Remission (CR) - Accelerated Approval Based on Data from the Phase 3 PhALLCON Trial, in which ICLUSIG Demonstrated Superiority in MRD-negative Complete Remission Rates and Comparable Safety to Imatinib OSAKA, Japan & CAMBRIDGE, Mass., March 19, 2024 BUSINESS WIRE )--Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ICLUSIG ® (ponatinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in con
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TAK
Sec Filings
- 4/25/24 - Form SD
- 4/19/24 - Form 6-K
- 4/15/24 - Form 6-K
- TAK's page on the SEC website