FRUZAQLA^™ (fruquintinib)

FRUZAQLA™ (fruquintinib) is a kinase inhibitor indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.

Important Information About EXKIVITY^® (mobocertinib)

Following discussions with the U.S. Food and Drug Administration (FDA), Takeda announced the initiation of the withdrawal of EXKIVITY (mobocertinib) on October 2, 2023.

The U.S. Food and Drug Administration (FDA) withdrew the US license for EXKIVITY on July 15, 2024.

For additional questions, please contact Takeda at 844-662-8532 between the hours of 8:00am and 6:00pm EST, or globaloncologymedinfo@takeda.com.

To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-844-217-6468 or the FDA at 1-800-FDA-1088 or .fda.gov/medwatch

Iclusig^® (ponatinib)

ICLUSIG is indicated for the treatment of adult patients with:

Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

• Newly diagnosed 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 [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).
• As monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL.

Chronic Myeloid Leukemia (CML)

• Chronic phase (CP) CML with resistance or intolerance to at least two prior kinase inhibitors.
• Accelerated phase (AP) or blast phase (BP) CML for whom no other kinase inhibitors are indicated.
• T315I-positive CML (chronic phase, accelerated phase, or blast phase).

Limitations of Use: ICLUSIG is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML [see Warnings and Precautions (5.7)].

Ninlaro^® (ixazomib)

NINLARO^® (ixazomib) is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Limitations of Use: NINLARO is not recommended for use in the maintenance setting or in newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone outside of controlled clinical trials.

Velcade^® (bortezomib)

VELCADE^® (bortezomib) is approved for the treatment of adults with multiple myeloma (a cancer of the plasma cells). VELCADE is also approved for the treatment of adults with mantle cell lymphoma (a cancer of the lymph nodes).