Booklet Updates - Leukemia

The following drug updates are listed by booklet title. This information is not found in the current version of these booklets, as these treatments were not FDA approved at the time the books were published.

Acute Lymphoblastic Leukemia (ALL ) in Adults
and
Acute Lymphoblastic Leukemia (ALL) in Children and Teens
and
The ALL Guide: Information for Patients and Caregivers

• In November 2024, the Food and Drug Administration (FDA) approved revumenib (Revuforj®) for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older.
• In November 2024, the Food and Drug Administration (FDA) approved obecabtagene autoleucel (Aucatzyl®) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
• In June 2024, the Food and Drug Administration (FDA) expanded the indication of blinatumomab (Blincyto®) to include the treatment of adult and pediatric patients one month and older with:
  • CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.  
  • Relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL).  
  • CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy.
• As of June 2024, Erwinaze® (asparaginase erwinia chrysanthemi) has been discontinued. Rylaze® (asparaginase erwinia chrysanthemi (recombinant)-rywn) is available as a treatment option.

Acute Myeloid Leukemia (AML) in Adults
and
Acute Myeloid Leukemia (AML) in Children and Teens
and
The AML Guide: Information for Patients and Caregivers

• In November 2024, the Food and Drug Administration (FDA) approved revumenib (Revuforj®) for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older.
• In July 2023, the Food and Drug Administration (FDA) approved quizartinib (Vanflyta®) in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test. 

Chronic Lymphocytic Leukemia​
and
The CLL Guide: Information for Patients and Caregivers

• In March 2024, the Food and Drug Administration (FDA) expanded the indication of lisocabtagene maraleucel (Breyanzi®) to include the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor.
  This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
• In December 2023, the Food and Drug Administration (FDA) approved pirtobrutinib (Jaypirca®) for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
  This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Chronic Myeloid Leukemia​
and
The CML Guide: Information for Patients and Caregivers

• In September 2023, the Food and Drug Administration (FDA) expanded the indication of bosutinib (Bosulif®) to include the treatment of
  • Adult and pediatric patients 1 year of age and older with chronic phase Ph+ chronic myelogenous leukemia (CML), newly diagnosed or resistant or intolerant to prior therapy.
  • Adult patients with accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy.