HEMATOLOGY

The FDA has updated the label for ibrutinib to include new overall survival data, an indication for the BTK inhibitor in combination with bendamustine/rituximab, and a new indication for patients with small lymphocytic lymphoma with a 17p deletion.

The FDA has granted a priority review to a supplemental biologics license application that would extend the indication for blinatumomab to include the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

With nearly a dozen new PI3K and BTK inhibitors currently in development for patients with relapsed chronic lymphocytic leukemia it is challenging to know which therapies are truly "next-generation" agents and which are "me too" products.

The FDA has granted a breakthrough therapy designation to pembrolizumab (Keytruda) as a treatment for patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

The FDA has granted nivolumab (Opdivo) a priority review for use in previously treated patients with classical Hodgkin lymphoma (cHL), giving the drug the potential to become the first PD-1 inhibitor approved for a hematologic malignancy.

Jeffrey Jones, MD, discusses treatment options for patients with chronic lymphocytic leukemia (CLL) who progress on, or become intolerant of, idelalisib or ibrutinib during their treatment.

The FDA approved the BCL-2 inhibitor venetoclax (Venclexta) for patients with chronic lymphocytic leukemia (CLL) who have a 17p deletion (del[17p]), following at least 1 prior therapy.

Multiple targeted therapies have shown promising signs of efficacy for patients with acute myeloid leukemia (AML), including the FLT3 inhibitor midostaurin and novel IDH inhibitors, with the ongoing potential for combination strategies in the future, according to Eytan M. Stein, MD.

Eytan Stein, MD, discusses targeting multiple mutations in patients with acute myeloid leukemia (AML).

John Leonard, MD, discusses the number of options doctors have to choose from when treating follicular lymphomas.

The studies examined ruxolitinib compared to placebo in the United States (COMFORT-I) and best available therapy in Europe (COMFORT-II) for patients with myelofibrosis.

Eytan Stein, MD, discusses the benefits of being able to identify drivers in acute myeloid leukemia and having drugs coming into the clinics to target those biological mutations.

Expanding on the efficacy shown in numerous single-group studies, a phase II study published in The Lancet Oncology showed lenalidomide significantly increased progression free survivalin patients with relapsed or refractory mantle cell lymphoma.

Frontline treatment with CPX-351 (Vyxeos) significantly boosted overall survival (OS) for older patients with high-risk, secondary acute myeloid leukemia (AML).

Six ongoing clinical trials investigating several idelalisib (Zydelig) combinations have been halted due to reports of increased adverse events such as death for patients with hematologic malignancies, according to an alert issued by the FDA.

The FDA has recieved a supplemental new drug application for a combination of ofatumumab (Arzerra), fludarabine, and cyclophosphamide, for patients with relapsed chronic lymphocytic leukemia (CLL).

Ibrutinib (Imbruvica) has been approved by the FDA as a frontline treatment for patients with chronic lymphocytic leukemia (CLL), based on data from the phase III RESONATE-2 trial.

The FDA has received a supplemental biologics license application to expand the approval of blinatumomab to include pediatric and adolescent patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Obinutuzumab (Gazyva) plus bendamustine, followed by obinutuzumab alone has been approved by the FDA as a treatment of patients with follicular lymphoma who were not responsive to a rituximab regimen, or who relapsed after rituximab-based therapy.

In this article, Shipra Gandhi, MD, Pallawi Torka, MD, and Francisco J. Hernandez Ilizaliturri, MD summarize the current clinical development of these novel agents in lymphoid malignancies.

Blinatumomab (Blincyto), an anti-CD19 agent, had a 69% response rate in patients with non-Hodgkin Lymphoma (NHL), according to updated data from a phase I, open-label, multicenter study.

The FDA has handed down a breakthrough therapy designation for midostaurin (PKC412) as a potential treatment for adults with newly diagnosed FLT3-mutated acute myeloid leukemia (AML).

The FDA has announced a full clinical hold for trials exploring pacritinib following reports of patient deaths. These deaths stemmed from intracranial hemorrhage, cardiac failure, and cardiac arrest in the phase III PERSIST-2 trial.

Single-dose fosaprepitant dimeglumine (Emend for injection) in combination with antiemetic agents has been approved by the FDA for the preventing

Peter Martin, MD, discusses the evolving paradigm of treatment for mantle cell lymphoma. Martin says the evolution of the paradigm currently includes Bruton's tyrosine kinase inhibitor, phosphoinositide 3-kinase inhibitor, immunomodulatory treatments, and immunotherapies.