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
Key updates to the National Comprehensive Cancer Network guidelines for gastric and esophageal cancers include the incorporation of immune checkpoint inhibitors spanning settings in patients with gastroesophageal cancer, the inclusion of fam-trastuzumab deruxtecan-nxki for those with HER2-positive gastric cancer, and the addition of recommended ramucirumab combinations for use in second- or later-line settings.
The combination of tilsotolimod plus ipilimumab failed to improve objective response rate over ipilimumab alone in patients with advanced melanoma who are refractory to a PD-1 inhibitor, missing the primary end point of the phase 2 ILLUMINATE-301 trial.
The trispecific killer cell engager product GTB-3550 was found to result in up to a 63.7% reduction in bone marrow blast levels in patients with high-risk myelodysplastic syndromes and relapsed/refractory acute myeloid leukemia.
The European Commission has approved an expanded label for pembrolizumab for use as a single agent in the treatment of select adult and pediatric patients aged 3 years and older who have relapsed/refractory classical Hodgkin lymphoma.
Single-agent bintrafusp alfa demonstrated efficacy, durability, and an acceptable toxicity profile when used in patients with locally advanced or metastatic biliary tract cancer who have progressed on or are intolerant of frontline platinum-based chemotherapy.
The FDA has granted priority review to the new drug application for the HIF-2α inhibitor belzutifan for the potential treatment of patients with von Hippel-Lindau–associated renal cell carcinoma that does not require immediate surgery.
Axicabtagene ciloleucel elicited a high objective response rate of 85%, with a complete response rate of 74% when used as a first-line therapy in patients with high-risk large B-cell lymphoma.
The FDA has issued a complete response letter regarding the biologics license application for ropeginterferon alfa-2b-njft for the treatment of patients with polycythemia vera.
A phase 3 trial evaluating single-agent cemiplimab will be stopped early due to positive results demonstrating an overall survival benefit over chemotherapy in patients with recurrent or metastatic cervical cancer who previously received chemotherapy.
The FDA has granted a fast track designation to poziotinib for use in previously treated patients with HER2 exon 20 mutations.
The FDA has extended the review period for the new drug application for belumosudil for use in patients with chronic graft-versus-host disease to allow for more time to review additional data submitted by the biopharmaceutical company.
The FDA has granted an orphan drug designation to the orally bioavailable, highly-specific G protein-coupled estrogen receptor agonist LNS8801 for the treatment of patients with metastatic uveal melanoma.
One in 7 Caribbean-born individuals with either breast or ovarian cancer had hereditary disease with an actionable pathogenic variant, which provides the opportunity for the utilization of targeted therapeutics and precise prevention strategies.
Interferon-alpha has been shown to significantly improve both myelofibrosis-free survival and overall survival over hydroxyurea and phlebotomy only in patients with polycythemia vera.
The combination of canakinumab plus docetaxel failed to significantly improve overall survival in patients with locally advanced or metastatic non–small cell lung cancer whose disease has progressed while on, or after, prior platinum-based chemotherapy and a PD-L1 agent, missing the primary end point of the phase 3 CANOPY-2 trial.
The FDA has approved the VENTANA ALK CDx assay as a companion diagnostic to identify patients with ALK-positive non–small cell lung cancer who are eligible to receive treatment with lorlatinib.
The United Kingdom’s National Institute for Health and Care Excellence will not recommend olaparib for the treatment of patients with hormone-relapsed, metastatic prostate cancer that harbors BRCA1 or BRCA2 mutations that has progressed on abiraterone acetate or enzalutamide.
Roche has withdrawn atezolizumab from the US market for the treatment of patients with metastatic urothelial carcinoma who had previously received platinum-based therapy.
One year into the COVID-19 pandemic has allowed for some reflection on the different evolutions that the oncology community went through in response to the many challenges posed by the virus.
The FDA has granted an accelerated approval to axicabtagene ciloleucel for the treatment of adult patients with relapsed/refractory indolent follicular lymphoma after 2 or more lines of systemic therapy.
The FDA has granted an orphan drug designation to cavrotolimod for the treatment of patients with Merkel cell carcinoma.
The combination of nivolumab and cabozantinib showcased significant benefit in terms of progression-free survival, overall survival, and responses vs sunitinib in the frontline treatment of patients with advanced renal cell carcinoma, as was underscored in data from the phase 3 CheckMate-9ER trial.
Poziotinib, when given at a daily dose of 16 mg, was found to demonstrate clinically meaningful activity when used in treatment-naïve patients with metastatic non–small cell lung cancer who harbor EGFR exon 20 mutations.
The filing of a biologics license application has been initiated with the FDA for toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma.
The FDA has expanded the indication for lorlatinib to include the frontline treatment of patients with ALK-positive non–small cell lung cancer.
The treatment paradigm for chronic lymphocytic leukemia has expanded beyond continuous treatment with BTK inhibitors with the addition of the time-limited regimen of venetoclax plus obinutuzumab.
Health Canada has approved the BTK inhibitor zanubrutinib for the treatment of adult patients with Waldenström macroglobulinemia.
Merck has withdrawn pembrolizumab from the US market for the treatment of patients with metastatic small cell lung cancer who experienced disease progression on or after platinum-based chemotherapy and at least 1 previous line of treatment.
As more options emerge in the mantle cell lymphoma paradigm, choosing among the agents available has become all the more challenging.
A supplemental new drug application has been submitted to the FDA for ivosidenib tablets as a potential therapeutic option for patients with previously treated, IDH1-mutated cholangiocarcinoma.
