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: [email protected]
The FDA has granted a priority review designation to a new drug application for a unique formulation of sodium thiosulfate for the prevention of cisplatin-induced ototoxicity in patients from 1 month to less than 18 years of age with localized, nonmetastatic, solid tumors.
The FDA has approved Guardant360® CDx for comprehensive genomic profiling in patients with any solid malignant cancer.
Atezolizumab in combination with paclitaxel did not demonstrate a statistically significant improvement in progression-free survival as a first-line treatment for patients with PD-L1–positive triple-negative breast cancer, failing to meet the primary end point of the IMpassion131 trial.
A CD30-targeted CAR T-cell therapy was found to elicit a high rate of durable complete responses (CRs) in heavily pretreated patients with relapsed/refractory Hodgkin lymphoma.
The FDA has cleared the clonoSEQ® assay to identify and monitor minimal residual disease in blood or bone marrow from patients with chronic lymphocytic leukemia.
The biologics license application for the investigational B7-H3–targeting monoclonal antibody omburtamab for use in pediatric patients with central nervous system/leptomeningeal metastases from neuroblastoma has been submitted to the FDA under the agency’s Rolling Review process.
Lorlatinib significantly improved progression-free survival in treatment-naive patients with advanced ALK-positive non–small cell lung cancer versus crizotinib, meeting the primary end point of the phase 3 CROWN trial.
Celsion Corporation will continue to follow patients with hepatocellular carcinoma enrolled on the phase 3 OPTIMA trial examining ThermoDox® in combination with radiofrequency ablation for overall survival.
China’s National Medical Products Administration has granted priority review status to a new drug application for ripretinib for the treatment of adult patients with advanced gastrointestinal stromal tumor who received previous treatment with 3 or more kinase inhibitors, including imatinib.
The FDA has granted a fast track designation for aspacytarabine as treatment for acute myeloid leukemia in adults aged 75 years or older who have comorbidities that preclude the utilization of intensive induction chemotherapy.
Tisagenlecleucel was found to elicit clinically meaningful activity in patients with relapsed/refractory follicular lymphoma, meeting the phase 2 ELARA trial’s primary end point of complete response rate.
The FDA granted an orphan drug designation to the oral investigational modified proprietary tyrosine derivative SM-88 as a treatment for patients with pancreatic cancer.
The FDA has approved tafasitamab-cxix (Monjuvi) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.
The advent of gene expression assays has provided predictive insight into chemotherapy benefit that can be combined with prognostic information yielded by gene expression profiling to better target patients with breast cancer who are at higher clinical risk for the use of adjuvant chemotherapy.
The FDA has approved atezolizumab (Tecentriq) in combination with cobimetinib (Cotellic) and vemurafenib (Zelboraf) in the treatment of patients with BRAF V600 mutation–positive advanced melanoma.
As new data emerge in the melanoma treatment paradigm, new questions have come to light regarding neoadjuvant/adjuvant strategies, reduced dosing for immunotherapy combinations, and approaches following progression on, or resistance to, PD-1 inhibition.
The FDA has granted breakthrough therapy designation to pevonedistat for the treatment of patients with higher-risk myelodysplastic syndromes.
The FDA has accepted 2 supplemental biologics applications for pembrolizumab in patients with triple-negative breast cancer; these are the first US applications for the anti–PD-1 therapy in breast cancer.
A biologics license application has been submitted to the FDA for idecabtagene vicleucel for the treatment of adult patients with relapsed and refractory multiple myeloma.
The FDA has approved the new VENTANA HER2 Dual ISH DNA Probe Cocktail test for use as a companion diagnostic for trastuzumab and to detect HER2 mutations in patients with breast cancer.
The FDA has granted a breakthrough therapy designation to MK-6482 for the treatment of patients with von Hippel-Lindau disease–associated renal cell carcinoma who have nonmetastatic tumors of less than 3 centimeters, unless immediate surgery is necessitated.
Hutchinson China Meditech Limited announces that The China National Medical Products Administration granted priority review to the new drug application for the MET inhibitor savolitinib for the treatment of patients with non–small cell lung cancer with MET exon 14 skipping mutations.
The FDA has granted a fast track designation to BDTX-189 for use in adult patients with solid tumors harboring an allosteric HER2 mutation or an EGFR or HER2 exon 20 insertion mutation who had progressed on previous treatment and have no acceptable options available.
The phase 2 ZENITH20 trial evaluating poziotinib in previously treated patients with non–small cell lung cancer and HER2 exon 20 insertion mutations met its prespecified primary end point.
The European Medicines Agency has granted access to the PRIME initiative for the Specific Peptide Enhanced Affinity Receptor T-cell therapy ADP-A2M4 for the treatment of patients with synovial sarcoma.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for ibrutinib in combination with rituximab for use in treatment-naïve patients with chronic lymphocytic leukemia.
Although antibody-drug conjugates have yet to receive regulatory approval in the lung cancer space, several emerging agents are showing early promise in clinical trials.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for belantamab mafodotin as a monotherapy in the treatment of adult patients with multiple myeloma who have received at least 4 prior therapies and whose disease is refractory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and aCD38-directed monoclonal antibody.
The mortality rate with COVID-19 appears to be higher in patients with cancer—especially those with lung cancer—compared with the general population, and several factors associated with mortality are beginning to emerge.
The FDA has granted a fast track designation for the PKCβ inhibitor enzastaurin for the treatment of patients with newly diagnosed glioblastoma.
