HEMATOLOGY

The CD19-directed CAR T-cell therapy axicabtagene ciloleucel (axi-cel; Yescarta) has been approved by the FDA for the treatment of adults with relapsed or refractory non-Hodgkin lymphoma (NHL), based on complete remission (CR) rate results from the phase II ZUMA-1 trial.

Robert Z. Orlowski, MD, PhD, recently discussed 2 cases of patients with multiple myeloma, and the treatment considerations and decisions he would make when treating these patients. Orlowski, chairman, ad interim, director of myeloma, and professor of medicine, The University of Texas MD Anderson Cancer Center, discussed these cases during a&nbsp;<em>Targeted Oncology</em>&nbsp;live case-based peer perspectives dinner.

Gilteritinib has been granted Fast Track designation by the FDA for adult patients with&nbsp;FLT3 mutation-positive relapsed/refractory acute myeloid leukemia, according to Tokyo-based Astellas Pharma.

According to a multivariate analysis of the Nordic MCL2 and MCL3 trials, the presence of <em>TP53</em> mutations predicts overall survival in younger patients with mantle cell lymphoma.

Srdan Verstovsek, MD, PhD, recently discussed treatment considerations and decisions in the cases of 2 patients with myeloproliferative neoplasms.&nbsp;Verstovsek,&nbsp;professor of medicine, Department of Leukemia, The University of Texas MD Anderson Cancer Center, discussed the case scenarios during a&nbsp;<em>Targeted Oncology</em>&nbsp;live case-based peer perspectives dinner.

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

About 71% of patients (17 of 24) with chronic lymphocytic leukemia exhibited an overall response (complete and/ or partial response) 4 weeks after receiving CAR T cell infusion therapy.

Javier Pinilla-Ibarz, MD, PhD, associate member, Malignant Hematology and Immunology Program at the H. Lee Moffitt Cancer Center, discusses how ibrutinib has transformed the treatment landscape of chronic lymphocytic leukemia.

A standardized analyses of 2 clinical trials showed three-fourths of patients with&nbsp;refractory non-Hodgkin lymphoma treated with&nbsp;the autologous anti-CD19 CAR T-cell therapy axicabtagene ciloleucel achieved objective responses, compared with 20% of patients who received standard therapy.

Results of a small, single-arm study reported at the 2017 Society of Hematologic Oncology meeting showed patients with refractory chronic lymphocytic leukemia achieved a high response rate with CD19-targeted CAR T-cell therapy.

Midostaurin has received approval from the European Commission as a treatment for adults with newly diagnosed <em>FLT3</em>-positive acute myeloid leukemia and advanced systemic mastocytosis, including aggressive systemic mastocytosis, SM with associated hematological neoplasm, and mast cell leukemia.

Understanding of the role of BCL-2 in acute myeloid leukemia (AML) continues to evolve, even as BCL-2&ndash;targeted therapy improves outcomes in the disease, AML specialist Daniel Pollyea, MD, MS said at the 2017 Society of Hematologic Oncology Annual Meeting in Houston, Texas.

Harry Erba, MD, PhD, professor of medicine, director, University of Alabama (UAB) Hematologic Malignancy Program, UAB School of Medicine, discusses using MRD to guide therapy in acute myeloid leukemia (AML).

Initial results from a phase III trial indicated that patients with newly diagnosed chronic myeloid leukemia treated with bosutinib (Bosulif) achieved response faster than patients treated with imatinib (Gleevec).

Robert Orlowski, MD, PhD,&nbsp;Florence Maude Thomas Cancer Research&nbsp;professor and chair, ad interim,&nbsp;Department of Lymphoma &amp; Myeloma&nbsp;at&nbsp;The University of Texas MD Anderson Cancer Center, discusses remaining questions with multiple myeloma treatment.

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.