FDA Approves Axi-Cel for Large B-cell Lymphoma
October 19th 2017The CD19-directed CAR T-cell therapy axicabtagene ciloleucel (axi-cel; Yescarta) has been approved by the FDA for the treatment of adults with relapsed or refractory non-Hodgkin lymphoma (NHL), based on complete remission (CR) rate results from the phase II ZUMA-1 trial.
Lenvatinib Application for Advanced HCC Accepted by FDA
September 27th 2017A supplemental new drug application for lenvatinib as a frontline systemic treatment for patients with advanced hepatocellular carcinoma has been accepted by the FDA, acccording to a statement from Eisai, the company developing the therapy.
Frontline Dabrafenib/Trametinib Combo Shows Promising Efficacy in BRAF+ NSCLC
September 19th 2017Frontline treatment with the combination of dabrafenib and trametinib induced an objective response rate of 64% (95% CI, 46%-79%) and a disease control rate of 75% in patients with <em>BRAF</em>-mutant metastatic non–small cell lung cancer.
Adjuvant Dabrafenib/Trametinib Combo Induces Relapse-Free Survival Rate of 58% in BRAF+ Melanoma
September 13th 2017After a median follow-up of 2.8 years, the 3-year relapse-free survival rate in patients with <em>BRAF</em>-mutant stage III melanoma who were treated with adjuvant dabrafenib and trametinib was 58% compared with 39% for placebo, according to findings from the phase III COMBI-AD study.
Abemaciclib Added to Aromatase Inhibitors Allows for PFS Boost in HR+/HER2- Breast Cancer
September 11th 2017When abemaciclib was added to a non-steroidal aromatase inhibitor in treatment-naive patients with HER2-negative, HR-positive advanced breast cancer, the combination reduced the risk of progression of disease or death by 46% compared with either anastrozole or letrozole alone, according to findings from the phase III MONARCH 3 trial.
Binimetinib/Encorafenib Combo Superior to Single-Agent Therapy in BRAF+ Melanoma
September 9th 2017For patients with <em>BRAF</em>-mutant advanced melanoma, the BRAF inhibitor encorafenib combined with the MEK inhibitor binimetinib demonstrated significant improvements in progression-free survival (PFS) compared with single-agent vemurafenib or encorafenib, according to updated findings from the phase III COLUMBUS trial presented at the 2017 ESMO Congress.
Durvalumab a Promising Option for Patients With Locally Advanced Lung Cancer
September 9th 2017Treatment with the PD-L1 inhibitor durvalumab (Imfinzi) improved median PFS by 11.2 months compared with placebo for patients with locally advanced, unresectable stage III non–small cell lung cancer who had not progressed following chemoradiotherapy, according to phase III results from the PACIFIC trial presented at the 2017 ESMO Congress.
Results of Phase III FLAURA Study Show Benefit of Frontline Osimertinib in EGFR+ NSCLC
September 9th 2017In results from the phase III FLAURA study of frontline osimertinib (Tagrisso) in patients with <em>EGFR</em>-mutant non–small cell lung cancer, osimertinib demonstrated a progression-free survival rate of 18.9 months (95% CI, 12.5-21.4), which was significantly improved over standard therapy.
Alectinib Demonstrates Promising Efficacy for ALK+ NSCLC With CNS Brain Metastases
September 9th 2017According to findings from the phase III ALUR and ALEX studies announced ahead of the 2017 ESMO Congress,<sup> </sup>Alectinib demonstrated promising efficacy for patients with <em>ALK</em>-translocated non–small cell lung cancer with central nervous system metastases in both the first- and second-line setting.
Rucaparib Highly Effective as Maintenance Therapy in Ovarian Cancer Subtypes
September 8th 2017The PARP inhibitor Rucaparib (Rubraca) improved median progression-free survival by 11.2 months compared with placebo as a maintenance treatment for patients with <em>BRCA</em>-mutant platinum-sensitive ovarian cancer, according to findings from the phase III ARIEL3 trial presented at the 2017 ESMO Congress.
Olaparib Tablets Approved by FDA for Ovarian Cancer Treatment
August 17th 2017The 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.
Survival Extended With Carfilzomib Combo in Myeloma, Final Analysis of ASPIRE Trial Shows
August 10th 2017The combination of carfilzomib (Kyprolis), lenalidomide (Revlimid), and dexamethasone reduced the risk of death by 21% compared with lenalidomide and dexamethasone alone for patients with relapsed multiple myeloma following prior treatment with 1 to 3 regimens.
Combinations, Biomarkers Will Be Future Focus in Metastatic NSCLC, Expert Says
August 8th 2017Roy S. Herbst, MD, PhD, discusses how the therapeutic paradigm will continue to evolve in the next few years for non–small cell lung cancer, with an increased emphasis on rational combinations and biomarkers.
CPX-351 Approved by FDA for 2 Types of AML
August 3rd 2017CPX-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 Approved by FDA for IDH2-Mutated AML
August 1st 2017Enasidenib (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.
Blinatumomab Granted Full Approval by the FDA for B-cell Precursor ALL
July 12th 2017Blinatumomab (Blincyto) has been granted a full approval by the FDA as a treatment for adults and children with relapsed/refractory B-cell precursor acute lymphoblastic leukemia, regardless of Philadelphia chromosome status.
First Flow Cytometry-Based Diagnostic Approved by FDA for Blood Cancer Detection
June 30th 2017ClearLLab multicolor reagents (T1, T2, B1, B2, M) has been approved by the FDA for the detection of chronic leukemia, acute leukemia, non-Hodgkin lymphoma, multiple myeloma, myelodysplastic syndrome, and myeloproliferative neoplasms.
Ublituximab Added to Ibrutinib Boosts ORR in Patients With Pretreated High-Risk CLL
June 7th 2017Ublituximab (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.
Lenalidomide Consolidation Therapy in CLL Demonstrates Notable Survival Plateau
June 7th 2017Lenalidomide consolidation therapy following induction with fludarabine and rituximab (Rituxan) was found to increase long-term survival over survival rates seen with FR or FR plus cyclophosphamide in an overall survival plateau that intrigued researchers when examined in patients with symptomatic, treatment-naive chronic lymphocytic leukemia without an 11q deletion.
Updated Results of MONALEESA-2 Trial Maintain Benefit of Ribociclib in HR+/HER2- Breast Cancer
June 3rd 2017Updated 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 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.