Articles

On October 18, 2017, the FDA approved axicabtagene ciloleucel (Yescarta; Kite Pharma), a CD19-directed genetically modified CAR T-cell immunotherapy, for the treatment, after ≥2 lines of systemic therapies, of adults with several types of relapsed or refractory large B-cell lymphoma, including (1) diffuse large B-cell lymphoma (DLBCL) not otherwise specified, (2) primary mediastinal large B-cell lymphoma, (3) high-grade B-cell lymphoma, and (4) DLBCL arising from follicular lymphoma.

On September 14, 2017, the FDA granted accelerated approval to copanlisib (Aliqopa; Bayer Healthcare) for the treatment of adults with relapsed follicular lymphoma who have received ≥2 previous systemic therapies. Copanlisib received priority review and an orphan drug designation for this indication.

Based on an unplanned post-hoc subset analysis of the CALGB 10603/RATIFY trial, the clinical benefit of maintenance therapy following midostaurin plus induction and consolidation chemotherapy for newly diagnosed patients with FLT3 mutations could not be discerned.

Combination treatment with nivolumab plus azacitidine produced encouraging response rates in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with poor-risk features, and in elderly patients as frontline therapy.

A phase 1 dose-escalation study of FLX925, a dual FLT3 and CDK4/6 inhibitor, showed modest antileukemic activity in adult patients with relapsed or refractory acute myeloid leukemia (AML).

An analysis of response and survival outcomes from the phase 1/2 AG221-C-001 study showed that continued treatment with enasidenib resulted in improved survival and response times in patients with mutant-IDH2 relapsed or refractory (R/R) acute myeloid leukemia (AML).

The results of the current phase 1b/2 study showed that the combination of azacitidine plus lirilumab was well-tolerated in heavily pretreated patients with relapsed acute myeloid leukemia (AML) and poor-risk disease features.

An updated safety and efficacy analysis of a phase 1b study demonstrated a promising benefit–risk profile with the combination of the BCL-2 inhibitor venetoclax with either decitabine or azacitidine in elderly, treatment-naïve patients with acute myeloid leukemia (AML) who are not candidates for intensive standard induction therapy.

The results of a post-hoc analysis of the RATIFY trial suggest that midostaurin decreases the cumulative incidence of relapse (CIR) in patients with FLT3 mutation–positive, newly diagnosed acute myeloid leukemia (AML), with no negative impact on survival.

This analysis showed that ivosidenib-treated patients with IDH1-mutated (mIDH1), relapsed/refractory, and untreated acute myeloid leukemia (AML) whose best response is a complete remission (CR) or CR with partial hematologic recovery achieve mIDH1 clearance ≤0.04%.