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 FDA has accepted for priority review the supplemental new drug application seeking the approval of trifluridine/tipiracil as a single agent or in combination with bevacizumab for use in select patients with refractory, metastatic colorectal cancer.
The FDA has approved omidubicel-onlv (Omisirge) to quicken the recovery of neutrophils in the body and reduce the risk of infection in adults and pediatric patients aged 12 years and older with blood cancers who are slated to undergo umbilical cord blood transplantation after a myeloablative conditioning regimen.
Adjuvant treatment with the combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) resulted in a statistically significant and clinically meaningful improvement in recurrence-free survival vs active surveillance in patients with a high risk of hepatocellular carcinoma recurrence following curative-intent resection or ablation.
The European Medicines Agency has granted Priority Medicines scheme designation to the personalized cancer vaccine mRNA-4157/V940 and pembrolizumab for use as adjuvant treatment in patients with high-risk, stage III or IV melanoma following complete resection.
The phase 3 LEAP-003 and LEAP-017 trials evaluating pembrolizumab plus lenvatinib did not meet their primary end points of overall survival in select patients with unresectable or metastatic melanoma and metastatic colorectal cancer, respectively.
AbbVie has announced the intention to voluntarily withdraw indications for ibrutinib in patients with mantle cell lymphoma who have previously received at least 1 therapy and in those with marginal zone lymphoma who require systemic treatment and have received at least 1 prior anti–CD20-based therapy.
Single-agent liposomal irinotecan resulted in a similar median overall survival and progression-free survival to that achieved with topotecan in patients with small cell lung cancer that had progressed on or following frontline platinum-based chemotherapy.
The FDA has granted accelerated approval to enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.
A new drug application seeking the approval of fruquintinib for use in the treatment of patients with refractory metastatic colorectal cancer has been submitted to the FDA.
Taletrectinib continued to demonstrate meaningful efficacy in the form of a durable objective response rate and a high intracranial ORR with acceptable tolerability in both TKI-naïve and crizotinib-pretreated patients with ROS1-positive non–small cell lung cancer.
The addition of cemiplimab to platinum-doublet chemotherapy continued to provide a clinically meaningful and statistically significant improvement in clinical benefit over chemotherapy alone in patients with advanced non–small cell lung cancer, irrespective of histology or PD-L1 expression level.
Amivantamab continued to be tolerable and efficacious in patients with non–small cell lung cancer harboring EGFR exon 20 insertion mutations whose disease progressed on platinum-based chemotherapy.
The FDA has granted full approval to pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability–high or mismatch repair–deficient solid tumors that have progressed following previous treatment and who have no satisfactory alternative options.
The combination of ribociclib and endocrine therapy (ET) significantly reduced the risk of disease recurrence vs standard adjuvant ET in patients with hormone receptor–positive/HER2-negative early breast cancer at risk of recurrence.
The combination of durvalumab, tremelimumab, and hypofractionated radiotherapy demonstrated early tolerability in patients with gynecologic malignancies and elicited objective responses in those with PD-L1–high tumors.
The FDA has approved retifanlimab-dlwr (Zynyz) for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma.
A new drug application seeking the approval of Lumisight, an optical imaging agent that detects cancerous tissue during initial lumpectomy to allow for a more complete resection, has been submitted to the FDA.
When the fully human IgG4 monoclonal antibody SRK-181 was given as a monotherapy or in combination with anti–PD-1 or PD-L1 agents in patients with locally advanced or metastatic solid tumors, it was found to be generally well tolerated and to demonstrate early indications of efficacy.
The FDA has granted an orphan drug designation to EP0042 for use as a potential therapeutic option in patients with acute myeloid leukemia with acquired resistance to FLT3 inhibitors.
Precision medicine has arrived in all stages of prostate cancer care and recommendations for optimal testing and how best to leverage the results to inform clinical decisions continue to rapidly evolve.
Durvalumab plus neoadjuvant chemotherapy followed by surgery and adjuvant single-agent durvalumab significantly improved event-free survival vs neoadjuvant chemotherapy and surgery alone in patients with resectable stage IIA-IIIB non–small cell lung cancer.
The combination of cabozantinib and atezolizumab did not significantly improve progression-free survival over cabozantinib alone in patients with locally advanced or metastatic clear cell or non–clear cell renal cell carcinoma who progressed during or following checkpoint inhibition, missing the primary end point of the phase 3 CONTACT-03 trial.
Lasofoxifene improved vaginal/vulvar symptoms compared with fulvestrant in premenopausal patients with locally advanced or metastatic estrogen receptor–positive/HER2-negative breast cancer harboring an ESR1 mutation.
The FDA has approved a single-dose, prefilled autoinjector presentation of pegfilgrastim-cbqv (Udenyca), which is a biosimilar of pegfilgrastim that is given the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.
The FDA approved an expanded indication for abemaciclib (Verzenio) in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor–positive, HER2-negative, node-positive, early breast cancer that is at a high risk of recurrence.
The FDA has granted an orphan drug designation to Temferon for use as a potential therapeutic option in patients with glioblastoma multiforme.
A biologics license application seeking the approval of cosibelimab in patients with metastatic or locally advanced cutaneous squamous cell carcinoma has been accepted for filing by the FDA.
The antibody-drug conjugate ARX788 was found to significantly improve progression-free survival compared with an active control in patients with HER2-positive locally advanced or metastatic breast cancer.
The FDA has provided PDS Biotechnology Corporation with guidance on the required contents of a design for a potential registrational trial examining PDS0101 in combination with PDS0301 and an FDA-approved immune checkpoint inhibitor in patients with recurrent or metastatic human papillomavirus–positive, ICI-refractory head and neck cancer.
The National Medical Products Administration of China has granted approval to tislelizumab in combination with fluoropyrimidine and platinum chemotherapy in the frontline treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma with a high PD-L1 expression.
