AML

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.

In an interview with&nbsp;<em>Targeted Oncology</em>, Jorge E. Cortes, MD, discussed the results from the QuANTUM-R trial, as well as some other studies investigating the use of quizartinib in different patient populations in AML.

Predisposition to forms of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in pediatric patients can be caused by either classical inherited bone marrow failure syndromes or recently discovered genetic predisposition syndrome with autosomal dominant inheritance, Marcin Wlodarski, MD, explained.

Combining cladribine and low-dose cytarabine alternating with decitabine (Dacogen) resulted in high response rates and improved survival compared with currently established low-intensity therapies for patients with acute myeloid leukemia who are older than 60, according to results newly published in <em>Lancet Haematology.</em>

Kamal Menghrajani, MD, a hematologist/oncologist at Memorial Sloan Kettering Cancer Center, discusses the latest advancement in the research of acute myeloid leukemia. After treating this disease the same way with traditional chemotherapy for over 40 years, researchers have finally come to an understanding of what is happening in the AML cells, leading to a more precise treatment of these patients.

A look back at all the&nbsp;FDA news&nbsp;that happened in the month of&nbsp;August 2018, including several new approvals, a priority review, breakthrough therapy designations, and more in a variety of cancer types.

Preclinical and phase I proof for CYAD-01 as well as preliminary findings from the ongoing THINK trial were presented at the 2018 American Society of Gene and Cell Therapy Annual Meeting.

David Sallman, MD, assistant member, Department of Malignant Hematology, Moffitt Cancer Center, explains the significance of the initial results from a recent phase 1B/2 trial combining APR-246 and azacitidine (Vidaza) in patients with TP53-mutant myelodysplastic syndrome and acute myeloid leukemia.

Guadecitabine failed to improve complete response rate&nbsp;and overall survival&nbsp;in treatment-na&iuml;ve adult patients with AML who are not candidates for intensive induction chemotherapy, missing the coprimary endpoints of the phase III ASTRAL-1, according to&nbsp;Astex Pharmaceuticals and Otsuka Pharmaceutical.

Quizartinib has been granted a breakthrough therapy designation by the FDA&nbsp;for the treatment of adult patients with relapsed/refractory&nbsp;<em>FLT3</em>-ITD&ndash;positive acute myeloid leukemia.

The FDA issued several approvals in July, including in colorectal cancer, breast cancer, prostate cancer, and acute myeloid leukemia.&nbsp;Here&rsquo;s a look back on the FDA happenings for the month of July 2018.

Therapeutic Approach for IDH2-Mutated AML

Ivosidenib (Tibsovo) has been granted approval by the FDA for the treatment of&nbsp;adult patients with relapsed/refractory <em>IDH1</em>-mutant acute myeloid leukemia.

The FDA has received a supplemental New Drug Application for venetoclax in combination with&nbsp;a hypomethylating agent or low-dose cytarabine as a frontline treatment for&nbsp;patients with acute myeloid leukemia who are ineligible for intensive chemotherapy, Genentech, the manufacturer of the BCL-2 inhibitor, has announced.

Romyelocel-L (human myeloid progenitor cells) has been granted a Regenerative Medicine Advanced Therapy designation by the FDA for the prevention of bacterial and fungal infections in patients with acute myeloid leukemia undergoing induction chemotherapy, according to Cellerant Therapeutics, Inc, the manufacturer of the therapy. RMAT designation holds similar advantages to breakthrough therapy designation.