Gina Columbus

The triplet regimen of elotuzumab plus pomalidomide and dexamethasone led to a 46% reduction in the risk of death compared with pomalidomide/dexamethasone alone in patients with relapsed/refractory multiple myeloma, according to updated findings of the phase II ELOQUENT-3 trial.

The FDA has approved ABP 980 (Kanjinti; trastuzumab-anns), a trastuzumab biosimilar, for the treatment of patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, marking the fifth approval by the agency for a trastuzumab biosimilar.

The FDA has approved pembrolizumab (Keytruda) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma as monotherapy whose tumors express PD-L1 (composite positive score [CPS] ≥1) and also in combination with platinum and fluorouracil (FU) for this patient population, irrespective of PD-L1 expression.

The fixed-dose combination of cedazuridine and decitabine demonstrated decitabine exposure equivalence of total 5-day dosing compared with intravenous decitabine in patients with intermediate- and high-risk myelodysplastic syndromes or chronic myelomonocytic leukemia, meeting the primary endpoint of the phase III ASCERTAIN trial.

Lincoln Nadauld, MD, PhD, sheds light on the current use of next-generation sequencing and the ongoing efforts to make this testing more widespread across the United States.

The combination of acalabrutinib (Calquence) and obinutuzumab (Gazyva) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with obinutuzumab/chlorambucil in patients with previously untreated chronic lymphocytic leukemia, meeting the primary endpoint of the phase III ELEVATE-TN trial.

Ixazomib in combination with dexamethasone did not demonstrate a significant improvement in overall hematologic response compared with standard therapy in patients with relapsed/refractory systemic light-chain amyloidosis, missing one of two primary endpoints in the phase III TOURMALINE-AL1 trial and leading to discontinuation of the study.

The FDA has granted momelotinib a fast track designation for use as a treatment of patients with intermediate- or high-risk myelofibrosis who previously received a JAK inhibitor.

The FDA has accepted a biologics license application for the investigational erythroid maturation agent luspatercept for the treatment of adult patients with very low- to intermediate-risk myelodysplastic syndromes-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions, as well as for adult patients with beta-thalassemia-associated anemia who require RBC transfusions.

The FDA approved a supplemental new drug application to update the label for gilteritinib to include final analysis data from the phase III ADMIRAL trial, which demonstrated an improvement in overall survival with the FLT3 inhibitor compared with salvage chemotherapy in adult patients with relapsed/refractory FLT3-mutant acute myeloid leukemia.

The FDA has granted a fast track designation to ARV-110, a PROTAC® protein degrader, for use as a treatment of patients with metastatic castration-resistant prostate cancer who have disease progression following ≥2 systemic therapies.

The European Medicines Agency has validated and accepted a marketing authorization application for the trastuzumab biosimilar HD201 (Tuznue), according to the developer Prestige BioPharma.

Within the week, thousands of abstracts spanning a multitude of tumor types will be presented at the 2019 ASCO Annual Meeting, many of which will lead to practice-changing implications for oncologists.

The FDA has approved ruxolitinib for the treatment of adult and pediatric patients ≥12 years of age with steroid-refractory acute graft-versus-host disease.

The FDA has approved the NovoTTF-100L System in combination with pemetrexed and platinum-based chemotherapy for the frontline treatment of patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma.

The triplet regimen of encorafenib, binimetinib, and cetuximab led to a 48% reduction in the risk of death compared with cetuximab and irinotecan-containing regimens in patients with BRAF V600E-mutant metastatic colorectal cancer who previously received up to 2 lines of therapy, meeting both primary endpoints of the phase III BEACON CRC trial.

Single-agent pembrolizumab (Keytruda) did not meet a prespecified endpoint of superior overall survival compared with chemotherapy as a second- or third-line treatment for patients with metastatic triple-negative breast cancer, missing the primary endpoint of the phase III KEYNOTE-119 trial.

Ivosidenib demonstrated a statistically significant improvement in progression-free survival by independent radiology review compared with placebo in patients with IDH1-mutant previously treated cholangiocarcinoma.

The European Commission has granted an approval to lenalidomide in combination with bortezomib and dexamethasone for the treatment of adult patients with previously untreated multiple myeloma who are ineligible for stem cell transplant, as well as pomalidomide in combination with bortezomib and dexamethasone for the treatment of adult patients with myeloma who have received ≥1 prior treatment regimen that included lenalidomide.

The FDA has approved the combination of avelumab and axitinib for the frontline treatment of patients with advanced renal cell carcinoma.

The FDA’s Oncologic Drugs Advisory Committee voted in favor of pexidartinib for an indication as a treatment of adult patients with symptomatic tenosynovial giant cell tumor.

The FDA has granted a breakthrough therapy designation to pomalidomide for use as a treatment for patients with HIV-positive Kaposi sarcoma who have received prior chemotherapy, as well as patients with HIV-negative Kaposi sarcoma.

Extended adjuvant treatment with neratinib given with or without antidiarrheal prophylaxis was associated with decreases in health-related quality of life in patients with HER2-positive breast cancer.

Bradley McGregor, MD, speaks about the various data that have emerged in renal cell carcinoma with combinations of immunotherapy, TKIs, and how he chooses between the available treatments for his patients.

The FDA has approved ramucirumab (Cyramza) monotherapy for patients with hepatocellular carcinoma who have an alpha fetoprotein of ≥400 ng/ML and have been previously treated with sorafenib.

The combination of nivolumab plus radiation therapy compared with temozolomide did not improve overall survival in patients with newly diagnosed O6-methylguanine-DNA methyltransferase-unmethylated glioblastoma multiforme, missing the coprimary endpoint of the phase III CheckMate-498 trial.

Daphne B. Stewart, MD, highlights the pivotal trials evaluating CDK4/6 inhibitors and what unanswered questions remain with this class of agents.

Guru Sonpavde, MD, discusses the current use of immunotherapy and the numerous strategies in development in bladder cancer.

The antibody-drug conjugate [fam-] trastuzumab deruxtecan (DS-8201) demonstrated encouraging responses in patients with unresectable and/or metastatic HER2-positive breast cancer that has been previously treated with ado-trastuzumab emtansine, according to topline findings from the phase II DESTINY-BreastO1 study.

Sameem Abedin, MD, discusses the recent encouraging data in chronic lymphocytic leukemia with venetoclax, duvelisib, and acalabrutinib.