Silas Inman

Articles by Silas Inman

The FDA has granted its approval to olaparib tablets (Lynparza) as a maintenance therapy for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy, regardless of <em>BRCA</em> status.

CPX-351 (Vyxeos), a fixed-combination of daunorubicin and cytarabine, has been approved by the FDA for adult patients with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC), based on an improvement in overall survival (OS) in a phase III study.

Enasidenib (Idhifa) has been approved by the FDA as a treatment for patients with relapsed or refractory <em>IDH2</em>-mutated acute myeloid leukemia (AML), based on findings from a phase I/II study. A companion diagnostic, the RealTime IDH2 Assay, was also approved for the detection of the <em>IDH2</em> mutation.

Ublituximab (TG-1101) in combination with ibrutinib (Imbruvica) met its primary endpoint of showing an improvement in objective response rate (ORR) compared with ibruitinib monotherapy in patients with previously treated high-risk chronic lymphocytic leukemia (CLL). In a presentation of findings from the phase III GENUINE trial during the 2017 ASCO Annual Meeting, data were reviewed demonstrating that the combination had an ORR of 78% in this patient population.&nbsp;

Lenalidomide consolidation therapy following induction with fludarabine and rituximab (Rituxan) was found to increase long-term survival over survival rates&nbsp;seen with FR or FR plus cyclophosphamide in an overall survival plateau that intrigued researchers when examined in&nbsp;patients with symptomatic, treatment-naive chronic lymphocytic leukemia without an 11q deletion.

Updated results from the phase III MONALEESA-2 trial presented during the 2017 ASCO Annual Meeting confirmed the benefit of frontline ribociclib (Kisqali) in combination with letrozole in patients with&nbsp;postmenopausal hormone receptor (HR)-positive, HER2-negative advanced breast cancer. The combination showed a progression-free survival (PFS) benefit of 9.3 months compared with letrozole plus placebo.

The irreversible pan-HER tyrosine kinase inhibitor neratinib showed single-agent activity across cohorts of patients with <em>HER2</em>-mutant advanced cancers, according to findings from the phase II SUMMIT study presented at the 2017 AACR Annual Meeting.

A biologics license application has been submitted for axicabtagene ciloleucel (KTE-C19) as a potential treatment for transplant ineligible patients with relapsed or refractory aggressive non-Hodgkin lymphoma.