Leukemia

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OVER THE LAST FEW years, significant advances were made in the treatment of patients with chronic lymphocytic leukemia (CLL). Several novel therapies, most of them oral, have now been approved by the Food and Drug Administration. These include Imbruvica (ibrutinib), a Bruton’s tyrosine kinase (BTK) inhibitor; Venclexta (venetoclax), a B-cell lymphoma-2 (BCL2) inhibitor; and Zydelig (idelalisib), a phosphoinositide 3-kinase (PI3K) inhibitor.

Venclexta (venetoclax), a BCL-2 inhibitor, had promising results in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). According to an updated analysis of a clinical trial, the agent led to negative minimal residual disease (MRD) in 40 percent of patients involved.

When Gary found out that his daughter was a match to donate bone marrow to a 69-year-old man, he collapsed and cried on the streets of Santa Monica.

Bosulif (bosutinib) was granted a priority review to a supplemental new drug application (sNDA) by the Food and Drug Administration (FDA) for use in the first-line treatment of patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML).

Blincyto (blinatumomab) was granted full approval by the Food and Drug Administration (FDA) to treat both children and adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (ALL), regardless of Philadelphia chromosome (Ph) status, according to the developer of the anti-CD19 immunotherapy, Amgen.

ClearLLab multicolor reagents (T1, T2, B1, B2, M) gained approval from the Food and Drug Administration (FDA) to detect chronic leukemia, acute leukemia, non-Hodgkin lymphoma, multiple myeloma, myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN). This is the first approval the agency received for immunophenotyping on a flow cytometer.

Rituxan Hycela (rituximab) was granted approval by the Food and Drug Administration (FDA) for adult patients with previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma (DLBCL) and previously untreated and previously treated chronic lymphocytic leukemia (CLL).

Imbruvica (ibrutinib) continues to demonstrate benefit in patients with chronic lymphocytic leukemia (CLL) who had at least one prior therapy, according to a four-year follow-up of the RESONATE study, which compared the BTK inhibitor to Arzerra (ofatumumab).

VYXEOS (CPX-351), a novel injection, was granted a new drug application (NDA) by the Food and Drug Administration (FDA), granting the drug a priority review for the treatment of acute myeloid leukemia (AML), according to Jazz Pharmaceuticals, the producer of the drug.