HEMATOLOGY

Based primarily on findings from the phase II CHRONOS-1 trial, copanlisib (Aliqopa) has received an accelerated approval from the FDA as a treatment for patients with relapsed follicular lymphoma who have received at least 2 prior systemic therapies.

Updated findings from the registration trial of the first FDA-approved CAR T-cell therapy showed that 83% of patients with acute lymphoblastic lymphoma achieved complete remission with complete or incomplete hematologic recovery, as reported at the 2017 Society of Hematologic Oncology Annual Meeting.<br /> &nbsp;

Guillermo Garcia-Manero, MD, discusses&nbsp;the potential impact of harnessing immunotherapeutics in MDS.

A biologics license application for the rituximab biosimilar Rixathon has been accepted by the FDA, according to Sandoz, the company developing the treatment.&nbsp;If it receives approval, rixathon would be indicated for&nbsp;follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia, as well as for rheumatoid arthritis.

Sundar Jagannath, MDDS, professor, Medicine, Hematology, and Medical Oncology, Mount Sinai Hospital, discusses the STORM and&nbsp;STOMP clinical trials &nbsp;in patients with multiple myeloma.

Jason J. Luke, MD, assistant professor of Medicine, The University of Chicago Medicine, discusses the combination of epacadostat and pembrolizumab (Keytruda) for the treatment of melanoma during the 2017 ESMO Annual Congress.

Multiple trials in Celgene&rsquo;s FUSION program, which is exploring regimens combining the PD-L1 inhibitor durvalumab (Imfinzi) with immunomodulatory and chemotherapy agents across several hematologic malignancies,&nbsp;have been placed on clinical holds by the FDA.

Partial clinical holds have been placed on 3 trials by the FDA, which are assessing nivolumab (Opdivo)-based combinations in patients with relapsed/refractory multiple myeloma.

A look back at all the FDA news that occurred in the month of August.

The FDA recently released a statement providing specific data from 2 phase III trials placed on hold in July investigating pembrolizumab (Keytruda) in multiple myeloma.

A supplemental new drug application seeking to add overall survival data from the phase III ENDEAVOR trial to the label for carfilzomib (Kyprolis) for use in patients with relapsed or refractory multiple myeloma has been accepted by the FDA.

A supplemental new drug application for bosutinib (Bosulif) has been granted a priority review by the FDA for the first-line treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia. The agency is scheduled to make a final decision by December 2017.<br /> &nbsp;

A historic approval of the first chimeric antigen receptor (CAR) T-cell therapy has been issued by the FDA, authorizing the use of tisagenlecleucel (Kymriah) for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse.

Rekha Rao, PhD, assistant professor, University of Kansas Medical Center, discusses the need to develop novel therapies in mantle cell lymphoma, including a study that explored the synergistic activity of p97 inhibitors with histone deacetylase 6 inhibitors.

A supplemental biologics license application for obinutuzumab (Gazyva) in combination with chemotherapy, followed by obinutuzumab alone, has been granted a priority review by the FDA for the first-line treatment of patients with follicular lymphoma.

Results from a recent retrospective study published in the<em> Journal of Clinical Oncology</em>^&nbsp;revealed hospice enrollment is low and use of aggressive treatment is high for elderly patients with acute myeloid leukemia.

According to results from a trial conducted by investigators from the Children&rsquo;s Oncology Group, treatment with arsenic trioxide consolidation was effective and safe in newly diagnosed pediatric patients with acute promyelocytic leukemia, allowing a significant reduction in cumulative anthracycline doses.

Eunice Wang, MD, discusses a study examining the biology of newly diagnosed patients with <em>FLT3</em>-positive acute myeloid leukemia who achieved a response to the FLT3 TKI crenolanib combined with chemotherapy.

Carfilzomib (Kyprolis) reduced the risk of death by 21% compared with bortezomib (Velcade) in patients with relapsed/refractory multiple myeloma, according to results from the phase III ENDEAVOR trial, now published in the<em> Lancet Oncology.</em>

Sattva S. Neelapu, MD, associate professor, The University of Texas MD Anderson Cancer Center, discusses the design of the ZUMA-1 trial in non-Hodgkin lymphoma.

Inotuzumab ozogamicin (Besponsa) has received FDA approval for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), based on findings from the phase III INO-VATE trial.

A supplemental biologics license application (sBLA) for brentuximab vedotin (Adcetris) has been granted a priority review by the FDA for the treatment of patients with cutaneous T-cell lymphoma (CTCL), according to Seattle Genetics, which codevelops the antibody-drug conjugate with Takeda.

Suzanne L. Topalian, MD, director, Melanoma Program, professor of Surgery, Johns Hopkins Medicine, discusses the impact of anti-PD-1 and anti-PD-L1 agents in the treatment of merkel cell carcinoma.

Development of chimeric antigen receptor T-cell therapies is in the works for both hematologic malignancies and solid tumors, but the most promising results to date have been seen with CD19-targeted CAR T cells in the treatment of B-cell acute lymphoblastic leukemia.

Sagar Lonial, MD, professor and chair, Department of Hematology &amp; Medical Oncology, Emory University School of Medicine, chief medical officer, Winship Cancer Institute of Emory University, discusses the importance of partnering with a myeloma center when managing multiple myeloma.