HEMATOLOGY

Blinatumomab (Blincyto) has received accelerated approval from the FDA for the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

The FDA has approved ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide as a treatment for patients with relapsed chronic lymphocytic leukemia (CLL). The approval was based on an improvement in progression-free survival (PFS) in the phase III COMPLEMENT-2 study.

Two-thirds of patients with chronic myeloid leukemia who ceased to receive the TKI treatment imatinib did not relapse after six months, according to Johan Richter, MD, PhD.

Blinatumomab almost doubles the overall survival of patients with relapsed/refractory acute lymphoblastic leukemia, according to Max Topp, MD.

Richard M. Stone, MD, Program Director, Adult Leukemia Program, Dana-Farber Cancer Institute, discusses the CALGB 10603 trial, which explored the use of midostaurin as a treatment for patients with FLT3-mutated acute myeloid leukemia.

Pracinostat has received a breakthrough therapy designation from the FDA, when given in combination with azacitidine, for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) aged 75 years or older, or for those who are ineligible for intensive chemotherapy, according to MEI Pharma, the company developing pracinostat.

Raoul Tibes, MD, PhD, physician-scientist at the University Hospital Head Myeloid Malignancies, Department of Internal Medicine II at the University Hospital in Würzburg, and adjunct consultant at Mayo Clinic, discusses the role of FLT3 inhibitors in the treatment of patients with acute myeloid leukemia.

Survivors of acute myeloid leukemia (AML) produce antibodies that kill leukemia cells following allogeneic hematopoietic stem cell transplantation (HSCT) that can be used to treat other patients with AML.

Patients with chronic phase chronic myeloid leukemia (CML) can safely conclude treatment of tyrosine kinase inhibitors (TKIs) following a maintained deep molecular remission, according to findings from the large EURO-SKI trial presented at the 2016 European Hematology Association (EHA) Congress.

Final data from a phase III trial of CPX-351 (Vyxeos) in older patients with high-risk, secondary acute myeloid leukemia (AML) revealed that CPX-351 reduced the mortality risk by 31% compared with cytarabine and daunorubicin (7+3), according to findings presented at the 2016 ASCO Annual Meeting.

Pembrolizumab (Keytruda) is associated with an exceptional overall response rate (ORR) in patients with relapsed/refractory Hodgkin lymphoma.

The FDA has lifted a clinical hold placed on a phase II study exploring the CD19-targeted CAR-T cell therapy JCAR015 for adult patients with relapsed or refractory B cell acute lymphoblastic leukemia.

The anti-CD22 antibody-drug conjugate inotuzumab ozogamicin demonstrated significantly improved progression-free survival (PFS) and complete remission (CR) rates compared with chemotherapy for patients with relapsed or refractory acute lymphoblastic leukemia (ALL).

Ibrutinib (Imbruvica) continued to demonstrate impressive antitumor activity in a pooled analysis of 243 patients with deletion 17p chronic lymphocytic leukemia.

Infusion with 19-28z chimeric antigen receptor (CAR) modified T-cells led to complete response (CR) rates of 77% to 90% and minimal residual disease (MRD)-CR rates of 68% to 70% in adult patients with relapsed or refractory B-cell acute lymphocytic leukemia (B-ALL).

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.