AML

A look back at all the FDA news that happened in the month of 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 and overall survival in treatment-naïve adult patients with AML who are not candidates for intensive induction chemotherapy, missing the coprimary endpoints of the phase III ASTRAL-1, according to 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.

Treating AML With Myelodysplasia-Related Changes