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FDA Grants Ivosidenib Combo Breakthrough Therapy Designation for IDH1+ AML
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Sangmin Lee, MD, discusses a potential way to overcome resistance to venetoclax in acute myeloid leukemia.

Richard M. Stone, MD, 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, according to preliminary results from the ongoing, randomized, phase III SIERRA trial that were presented at the 2019 Transplantation and Cellular Therapy Meetings.

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

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

Targeted agents are routinely used to treat many cancers and have improved outcomes for patients with solid tumors and hematological malignancies alike. Recently, targeted therapies made their way into the armamentarium for acute myeloid leukemia, representing the first therapeutic advances for AML in decades.

Several oncology experts discuss the FDA approvals they found most significant in 2018.

A look back at all the FDA news that happened in the month of November 2018, including several new approvals, priority reviews, a fast track designation, and an accelerated approval, across a variety of cancer types.

An update on the pivotal phase III QuANTUM-R study presented at the 2018 ASH Annual Meeting demonstrated overall survival benefit across patient subgroups with quizartinib in patients with relapsed/refractory <em>FLT3</em>-ITD–mutated acute myeloid leukemia.

Among older patients with acute myeloid leukemia who were ineligible for intensive chemotherapy, preliminary findings demonstrated that more than 70% achieved complete responses to venetoclax in combination with hypomethylating agents.

It may be possible for hematologists to determine subtypes of acute myeloid leukemia based on genetic analsysis of blood samples in 7 days or less. According to Amy Burd, PhD, this process could play an important role in diagnosing and treating patients.

According to updated data from the phase II ELIANA study, CD19-targeted CAR T-cell therapy tisagenlecleucel as treatment of pediatric and young adult patients with relapsed or refractory acute lymphoblastic leukemia sustained rates of relapse-free survival and overall survival at 24 and 18 months.

Gilteritinib has been approved by the FDA for the treatment of adult patients with <em>FLT3</em> mutation–positive relapsed or refractory acute myeloid leukemia.

A new drug application for quizartinib has been granted a priority review by the FDA for the treatment of adult patients with relapsed/refractory <em>FLT3</em>-ITD–positive acute myeloid leukemia. The designation is based on findings from the phase III QuANTUM-R study.

Glasdegib (Daurismo) has been granted FDA approval for combination use with low-dose cytarabine for the treatment of patients with newly-diagnosed acute myeloid leukemia who are aged 75 years or older or who are ineligible for intensive chemotherapy.

Venetoclax (Venclexta) has been granted an accelerated approval by the FDA for combined use with azacitidine or decitabine or low-dose cytarabine as a treatment for adult patients with newly-diagnosed acute myeloid leukemia who are aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

<br /> Mary-Beth Percival, MD, discusses the ongoing development of FLT3 inhibitors and other current research in patients with AML.

Mutations in 8 high-risk genes are associated with an acute myeloid leukemia (AML) diagnosis, according to a deep sequencing analysis. Hetty Carraway, MD, said that these findings lay the ground work for upcoming research on early detection and novel treatment strategies.

Patients with acute myeloid leukemia now have more treatment options available than ever, due to some major changes to the field over the last year. With 2 drugs already approved for patients with <em>IDH</em> mutations and 4 new drugs expected to receive approval in the next year, it is a more hopeful time than ever for this patient population.

Chronic lymphocytic leukemia is characterized by the clonal proliferation and accumulation of small, mature-appearing CD5-positive B lymphocytes in the blood, bone marrow, and secondary lymphoid tissues. A CLL diagnosis is established by the presence of more than 5x109/L peripheral lymphocytes co-expressing CD5, CD19, and CD23, and weakly expressing CD20, CD79b, and surface immunoglobulin. Small lymphocytic lymphoma represents a clinical variant of CLL and is similarly managed.

Lloyd Damon, MD, discussed novel therapies in AML with a focus on FLT3 and IDH1/2 inhibitors.<br />

Rami S. Komrokji, MD, reflects on the diverse treatment landscape of AML and touches on the prognostic importance of biomarkers.

In an interview with <em>Targeted Oncology</em>, Jay Yang, MD, discussed the evolution of the treatment landscape for AML and the future outlook for these treatments.

















































