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
FDA Approves Biosimilar Pegfilgrastim-cbqv for Febrile Neutropenia
March 6th 2023The 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.
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FDA Expands Abemaciclib Indication in HR+/HER2–, Node+, High-Risk Breast Cancer
March 3rd 2023The 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.
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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.
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Tislelizumab Plus Chemo Approved in China for PD-L1–High Advanced Gastric/GEJ Adenocarcinoma
February 27th 2023The 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.
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Trastuzumab Deruxtecan Garners Approval in China for HER2+ Metastatic Breast Cancer
February 24th 2023The National Medical Products Administration of China has approved the use of single-agent fam-trastuzumab deruxtecan-nxki in adult patients with unresectable or metastatic HER2-positive breast cancer who previously received 1 or more anti–HER2-based regimens.
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Cemiplimab Plus Chemotherapy Approaches EU Approval for PD-L1+ NSCLC
February 24th 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of cemiplimab-rwlc in combination with platinum-based chemotherapy as frontline treatment for adult patients with advanced non–small cell lung cancer with PD-L1 expression of 1% or higher.
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Cabozantinib After CPI-Based Combination Therapy Showcases Early Efficacy in Advanced RCC
February 18th 2023Treatment with cabozantinib elicited responses in patients with locally advanced or metastatic renal cell carcinoma with a clear-cell component who had progressed after first-line treatment with checkpoint inhibitor–based combination therapy.
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The addition of pembrolizumab to chemotherapy resulted in a significant and clinically meaningful improvement in overall survival, progression-free survival, and objective response rate vs chemotherapy alone when used as first-line treatment in patients with advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma.
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The fully-human scFv CD19-targeted CAR T-cell therapy JCAR021 elicited durable responses but with a high rate of neurotoxicity when administered at a dose of 7 x 106 cells/kg in patients with relapsed or refractory large B-cell lymphoma, according to data from a phase 1/2 trial.
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Maveropepimut-S Plus Pembrolizumab and Cyclophosphamide Shows Early Promise in R/R DLBCL
February 13th 2023The combination of maveropepimut-S, pembrolizumab, and intermittent low-dose cyclophosphamide elicited responses in patients with relapsed or refractory diffuse large B-cell lymphoma, according to preliminary findings from the phase 2b VITALIZE trial.
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FDA Grants Regular Approval to Dostarlimab for dMMR Endometrial Cancer
February 9th 2023The FDA has granted a regular approval to dostarlimab-gxly (Jemperli) for adult patients with mismatch repair–deficient, recurrent or advanced endometrial cancer that has progressed on or after a prior platinum-containing regimen in any setting and who are not candidates for curative surgery or radiation.
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Neoadjuvant Pembrolizumab Elicits Deep Responses in Localized MSI-H/dMMR Solid Tumors
January 30th 2023Neoadjuvant pembrolizumab was found to have high clinical activity and an acceptable safety profile in patients with localized microsatellite instability–high/deficient mismatch repair solid tumors.
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FDA Approves Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
January 27th 2023The FDA has approved pirtobrutinib (Jaypirca) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma following at least 2 lines of systemic therapy, including a BTK inhibitor.
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The combination of nivolumab (Opdivo) and chemotherapy continued to provide a clinically meaningful long-term survival benefit and deeper responses than chemotherapy alone in previously untreated patients with advanced gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, according to 3-year follow-up data from the phase 3 CheckMate-649 trial.
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Mobocertinib Garners Approval in China for EGFR Exon 20 Insertion+ NSCLC
January 11th 2023The National Medical Products Administration of China has approved mobocertinib for the treatment of adult patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations and whose disease progressed on or following platinum-based chemotherapy.
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Imetelstat Provides Durable Transfusion Independence in Lower-Risk MDS
January 4th 2023Significant and durable transfusion independence was achieved with imetelstat vs placebo in patients with lower-risk myelodysplastic syndromes who were relapsed, refractory, or ineligible for erythropoiesis-stimulating agents, meeting the primary and a key secondary end point of the phase 3 IMerge trial.
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Obecabtagene Autoleucel Meets Primary End Point of ORR in R/R B-cell Acute Lymphoblastic Leukemia
December 20th 2022Obecabtagene autoleucel elicited an overall remission rate of 70% in 50 efficacy-evaluable adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia, meeting the primary end point of the phase 2 FELIX trial.
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FDA Approves Nadofaragene Firadenovec for High-risk Non–Muscle Invasive Bladder Cancer
December 16th 2022The FDA has approved nadofaragene firadenovec-vncg (Adstiladrin) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.
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Frontline Zolbetuximab Plus CAPOX Meets PFS, OS End Points in Claudin 18.2+ Gastric or GEJ Cancers
December 16th 2022The addition of zolbetuximab to capecitabine and oxaliplatin resulted in a statistically significant improvement in progression-free survival and overall survival vs placebo/CAPOX in patients with Claudin 18.2–positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal cancers, meeting the primary and secondary end points of the phase 3 GLOW trial.
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