Associate Editorial Director, OncLive®
Kristi Rosa joined MJH Life Sciences in 2016 and has since held several positions within the company. She helped launch the rapidly growing infectious disease news resource Contagion, strengthened the Rare Disease Report, of HCPLive, and now oversees OncLive and its flagship publication OncologyLive. Prior to working at the company, she served as lead copywriter and marketing coordinator at The Strand Theater. Email: krosa@onclive.com
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab plus ipilimumab with 2 cycles of platinum-based chemotherapy for the frontline treatment of patients with metastatic non–small cell lung cancer.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for niraparib for frontline maintenance treatment in patients with advanced ovarian cancer who are responsive to platinum-based chemotherapy.
Enfortumab vedotin-ejfv resulted in a significant improvement in overall survival versus chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who received prior treatment with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor.
The European Medicines Agency has validated a Type II Variation for nivolumab in combination with ipilimumab as a frontline treatment for previously untreated patients with unresectable malignant pleural mesothelioma.
The FDA has approved the expanded use of the CINtec PLUS Cytology assay for women who undergo cervical cancer screening and test positive for high-risk types of human papillomavirus.
The bispecific antibody CDX-527 is now under investigation in patients with advanced or metastatic solid tumors who have progressed during or following standard-of-care treatment with the recent initiation of a open-label phase 1 trial.
The FDA has granted a breakthrough therapy designation to magrolimab for the treatment of patients with newly diagnosed myelodysplastic syndrome.
Investigators are evaluating the clinical and immunological impact of the experimental, engineered fusion protein ALKS 4230 on the tumor microenvironment of several advanced, malignant solid tumors in the recently initiated phase 2 ARTISTRY-3 trial.
The FDA granted a fast track designation to the highly-selective N-terminal domain inhibitor EPI-7386 for the treatment of adult patients with metastatic castration-resistant prostate cancer who are resistant to standard-of-care options.
The wellbeing and job performance of oncology professionals has been significantly impacted by the COVID-19 pandemic, and although the extent of this impact is varied between countries, it has been suggested to be related to the crude mortality rate of the virus.
The first patient has been enrolled on the phase 2 portion of the LIO-1 trial, which will examine the combination of lucitanib plus nivolumab in those with gynecologic cancers.
Although the addition of ixazomib to lenalidomide and dexamethasone showed an improvement in progression-free survival in patients with newly diagnosed multiple myeloma who are not candidates for autologous stem cell transplant, it was not determined to be of statistical significance.
The novel anti-folate receptor alpha antibody-drug conjugate STRO-002 demonstrated encouraging efficacy with a tolerable safety profile in patients with advanced platinum-resistant or refractory epithelial ovarian cancer.
The FDA has approved the Oncomine Dx Target Test as a companion diagnostic to identify patients with RET fusion–positive non¬–small lung cancer who are candidates to receive the recently approved targeted therapy pralsetinib.
The European Commission has approved an expanded indication of ibrutinib for use in combination with rituximab in treatment-naïve adult patients with chronic lymphocytic leukemia.
The China National Medical Products Administration has approved niraparib for use as a first-line maintenance treatment in adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who achieve a complete or partial response to first-line platinum-based chemotherapy.
The FDA has granted a breakthrough therapy designation to plinabulin for chemotherapy-induced neutropenia.
A supplemental biologics license application has been submitted to the FDA for daratumumab plus hyaluronidase-fihj for the treatment of patients with amyloid light chain amyloidosis.
The first-in-class radioiodinated phospholipid drug conjugate CLR 131 elicited a clinically meaningful overall response rate of 40% in patients with triple-class refractory multiple myeloma who received a total administered dose of 60 mCi or greater.
The FDA has approved copper Cu 64 dotatate injection for the localization of somatostatin receptor–positive neuroendocrine tumors.
The FDA has issued an alert that the phase 3 IMpassion131 trial failed to show the effectiveness of atezolizumab plus paclitaxel in treatment-naïve patients with inoperable locally advanced or metastatic triple-negative breast cancer.
The FDA has granted pralsetinib a priority review for the treatment of patients with advanced or metastatic RET-mutant medullary thyroid cancer and RET fusion–positive thyroid cancer.
The FDA has approved pralsetinib for the treatment of patients with metastatic, RET fusion–positive non-small cell lung cancer.
A supplemental biologics license application has been filed with the FDA for axicabtagene ciloleucel for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma following 2 or more previous lines of systemic therapy.
Ruxolitinib continued to elicit a significantly higher overall response rate compared with best available therapy at day 28 in patients with steroid-refractory acute graft-versus-host disease.
Capmatinib continued to elicit a significant, durable responses in patients with metastatic non–small cell lung cancer whose tumors harbor a MET exon14 skipping mutation.
Blinatumomab monotherapy as consolidation therapy prior to allogeneic hematopoietic stem cell transplant resulted a significant improvement in event-free survival and a lower risk of recurrence in children with high-risk B-cell precursor–acute lymphoblastic leukemia.
The orally available ROCK2 selective inhibitor belumosudil continues to elicit clinically meaningful overall response rates in patients with chronic graft-versus-host disease (cGVHD) who have received ≥2 prior lines of systemic therapy
The overall response rates with subcutaneous daratumumab proved to be similar to that of the intravenous formulation of the drug irrespective of body weight.
The FDA has approved oral azacitidine for the continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy who are not able to complete intensive curative therapy.
