AML

The FDA approved several indications throughout the month of April 2018. A number of drugs were granted priority review and Fast Track designation. The FDA also halted all clinical trials using tazemetostat as treatment, and new initiatives were introduced to help ease the development of genetic and genomic-based tests. Check out our list of all FDA happenings from April 2018.

Based on data from the ongoing phase III ADMIRAL study, Astellas Pharma, the manufacturer of&nbsp;gilteritinib, has announced the submission of a new drug application to the FDA seeking approval for the FLT3 inhibitor as a treatment for adult patients with <em>FLT3</em> mutation&ndash;positive relapsed or refractory acute myeloid leukemia.

Studies have shown that older patients with either active, relapsed, or refractory acute myeloid leukemia have had lower survival rates, poor risk assessments, and limited therapeutic options. The standard care of these patients is salvage chemotherapy. Investigators are pretreating patients in this high-risk population with Iomab-B, a novel radiolabeled antibody&ndash;drug conjugate&nbsp;as part of a stem cell transplantation regimen in hopes of improving remission and survival outcomes.

According to results published in <em>The&nbsp;New England Journal of Medicine</em>, molecular minimal residual disease was associated with a higher rate of relapse and a lower rate of relapse-free survival and overall survival for patients with newly-diagnosed acute myeloid leukemia.

Several new indications were approved by the FDA in March, including blinatumomab (Blincyto)&nbsp;for MRD+ ALL, brentuximab vedotin (Adcetris) for Hodgkin lymphoma, and a 4-week nivolumab (Opdivo) dosing schedule across several indications. Here&rsquo;s a look back on the FDA happenings for the month of March 2018.

Stuart L. Goldberg, MD,&nbsp;discussed the management of patients with acute myeloid leukemia as well as those with myelodysplastic syndrome.

Blinatumomab (Blincyto) has been granted an accelerated approval by the FDA for the&nbsp;treatment of patients with B-cell precursor acute lymphoblastic leukemia who are in remission but still have minimal residual disease.

New indications were approved by the FDA within the last month, including abemaciclib for HER2-negative breast cancer, durvalumab for non&ndash;small cell lung cancer, and abiraterone acetate for castration-sensitive prostate cancer.

The treatment paradigm of acute myeloid leukemia has not changed much in the last several decades, but with 4 new drugs approved by the FDA within the span of a few months, 2017 easily became the most promising year yet for the treatment of AML.