HEMATOLOGY

Neratinib, an experimental TKI being developed for breast cancer, achieved a 36% clinical benefit rate in a phase II trial, according to a poster presented June 5, 2016 at the ASCO Annual Meeting in Chicago.

A majority of patients (66%) with classical Hodgkin lymphoma (cHL) who had progressed after receiving autologous stem cell transplant (ASCT) and brentuximab vedotin (adcetris) experienced a response to nivolumab (Opdivo) monotherapy, findings from the phase II CheckMate-205 trial showed when presented at the 2016 ASCO Annual Meeting.

The treatment paradigm for relapsed/refractory chronic lymphocytic leukemia (CLL) is slowly expanding, with clinical trials starting and a new generation of drugs being ushered in, says Susan M. O'Brien, MD.

Despite the RESONATE-2 trial having demonstrated the efficacy of ibrutinib (Imbruvica) in treatment-naive elderly patients with chronic lymphocytic leukemia (CLL), Jennifer Brown, MD, explains that oncologists should carefully select patients to receive the drug depending on their age, comorbidities, and risk.

CPX-351 (Vyxeos) has been granted a breakthrough therapy designation by the FDA as a treatment for patients with therapy-related acute myeloid leukemia or AML with myelodysplasia-related changes.

Sue Naeyaert, senior director of Biosimilars Policy, EMD Serono, discusses the long-term impact that biosimilars could potentially have on the field of oncology.

Extended follow-up data continue to demonstrate the efficacy and tolerability of ibrutinib in previously treated patients with chronic lymphocytic leukemia, including those with high-risk gene mutations and prognostic features.

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).