LEUKEMIAS

The review period on the new drug application for quizartinib as a treatment for adult patients with&nbsp;relapsed/refractory <em>FLT3</em>-ITD&ndash;positive acute myeloid leukemia has been extended by the FDA by 3 months.&nbsp;This provides the FDA with additional time to review more data supplied by&nbsp;Daiichi Sankyo, the manufacturer of the FLT3 inhibitor.

A look back at all the&nbsp;FDA news&nbsp;that happened in March 2019, including several new approvals, a clinical hold, an orphan drug designation, and more.

Overall survival was significantly improved in&nbsp;patients with relapsed/refractory <em>FLT3</em> mutation&ndash;positive acute myeloid leukemia who were treated with the FLT3 inhibitor gilteritinib, according to&nbsp;updated findings presented during the 2019 AACR Annual Meeting.

During a <em>Targeted Oncology</em> live case-based peer perspectives program, B. Douglas Smith, MD, discussed his clinical consideration for the management of acute myeloid leukemia. Smith explained his treatment decisions during the dinner event in 2 case scenarios of patients with AML.

During a <em>Targeted Oncology </em>case-based peer perspectives program, Elias Jabbour, MD, discussed his clinical considerations for the management of chronic myeloid leukemia in chronic phase.&nbsp;Jabbour explained his treatment decisions during the live event based on a case scenario of a patient with CML-CP.

Jacqueline C. Barrientos, MD, MS, discusses the role of acalabrutinib, a second-generation BTK inhibitor, that is available for patients with chronic lymphocytic leukemia, but not yet approved.

Genomic testing could increasingly be utilized to guide treatment decisions for Veteran patients with cancer. Two recent announcements confirm an emerging focus from Veterans Affairs on genetic testing that provides more informed and tailored cancer care for US Veterans.

Eytan M. Stein, MD, sheds light on the current treatment landscape of AML and underscored the importance of molecular monitoring. In addition, he highlights where the field of AML is headed.

The combination regimen of venetoclax and obinutuzumab is seeking FDA approval; a supplemental new drug application has been submitted to the FDA&nbsp;for the combination as a treatment for patients with&nbsp;previously untreated chronic lymphocytic leukemia who also have coexisting medical conditions, according to an announcement from&nbsp;Genentech (Roche).

Jacqueline C. Barrientos, MD, MS, discusses emerging agents and combinations in CLL based on recent trial data.

Richard M. Stone, MD,&nbsp;discusses emerging agents and combinations for older patients with AML, along with his preferences for treatment.

All but 1 of the first 19 patients with relapsed/refractory AML randomized to receive iodine-131 apamistamab had a complete response and went on to have successful engraftment of allogeneic hematopoietic stem cell transplant,&nbsp;according to preliminary results from the ongoing, randomized, phase III SIERRA trial that were presented at the 2019 Transplantation and Cellular Therapy Meetings.&nbsp;

Adding ibrutinib to&nbsp;CAR T-cell therapy led to improved responses in patients with relapsed/refractory chronic lymphocytic leukemia, according to preliminary findings presented at&nbsp;the 2019 Transplantation and Cellular Therapy Meetings.

A supplemental new drug application for ivosidenib has been granted a priority review designation by the FDA&nbsp;for the frontline treatment of patients <em>IDH1</em>-mutant acute myeloid leukemia who are ineligible for standard chemotherapy, according to&nbsp;Agios, the manufacturer of ivosidenib.

The first attempt to quantify therapy-related myelodysplastic syndrome or acute myeloid leukemia in the era of widespread platinum-based chemotherapy has found that tMDS/AML risks were statistically significantly elevated after chemotherapy for 22 of 23 solid cancers, according to a new study in <em>JAMA Oncology.</em>

A novel agent demonstrated efficacy in treating patients with early recurrent or refractory acute myeloid leukemia when administered via continuous intravenous infusion, according to results from a phase I/II trial recently published in <em>Cancer. </em>The agent was also well tolerated among patients.

John F. Seymour, MBBS, PhD, discusses some emerging themes from recent research for targeted therapies as treatment of patients with chronic lymphocytic leukemia.

Christopher R. Cogle, MD, a professor of medicine at the University of Florida, discusses the greatest challenge in treating patients with myelodysplastic syndromes and acute myeloid leukemia.

Clinical researchers Dennis Slamon, MD, PhD, and Brian Druker, MD, were recently honored with the 2019 Sj&ouml;berg Prize for their ground-breaking contributions toward targeted therapy for patients with breast cancer and chronic myeloid leukemia, respectively.

Lead iLLUMINATE study author Carol Moreno, MD, PhD, discusses the safety and efficacy results from the iLLUMINATE trial which led to the FDA approval of&nbsp;ibrutinib plus obinutuzumab in CLL.

Matthew S. Davids, MD, MMSc, discusses findings from an updated analysis of the&nbsp;phase III DUO study in patients with CLL.

A look back at all the&nbsp;FDA news&nbsp;in oncology from the month of&nbsp;January 2019, including several new approvals, breakthrough therapy designations, and a partial clinical hold.

In an interview with <em>Targeted Oncology</em>, Ian W. Flinn, MD, PhD, discussed the potential impact of duvelisib&nbsp;on patients with CLL. Flinn serves as the lead investigator of the DYNAMO and DUO studies in duvelisib.

The combination of ibrutinib and obinutuzumab has gained FDA approval for the first-line treatment of patients with&nbsp;chronic lymphocytic leukemia or small lymphocytic lymphoma, based&nbsp;on data from the phase III iLLUMINATE trial.

Jordan Gauthier, MD, MSc, discussed the results presented at the 2018 ASH Annual for this clinical trial and where the research is headed for patients with CLL. He also highlights another promising combination for this patient population that was presented at the meeting as well.

A triplet regimen consisting of chlorambucil and rituximab in combination with an individualized dose of lenalidomide can potentially be used as a frontline treatment for patients with advanced chronic lymphocytic leukemia who are older or unfit for standard treatment with fludarabine, cyclophosphamide, and rituximab.

Jordan Gauthier, MD, MSc, discusses the rationale for combining ibrutinib with CD19-targeting chimeric antigen receptor T cells for the treatment of patients with chronic lymphocytic leukemia.

Kerry A. Rogers, MD,&nbsp;discusses phase II findings with obinutuzumab, ibrutinib, and venetoclax and the future of dose-limited regimens in CLL.

Dasatinib (Sprycel) tablets has been approved by the FDA to be used in combination with chemotherapy for the treatment of pediatric patients &ge;1 year of age with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.<br /> &nbsp;

Precision medicine has produced some dramatic successes in patients with advanced cancer. With developments in molecular profiling, targeted therapies are being applied to multiple tumors, most notably in advanced melanoma, NSCLC, and several types of leukemia. Alison Schram, MD, and David M. Hyman, MD, point out the challenges in determining the proportion of patients who will benefit from receiving targeted therapies.