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 Accepts Application for Pedmark in Prevention of Cisplatin-Induced Ototoxicity in Solid Tumors
June 22nd 2021The FDA has accepted for filing the resubmission of the new drug application for a unique formulation of sodium thiosulfate, for the prevention of ototoxicity that is induced by cisplatin chemotherapy in patients between the ages of 1 month and 18 years who have localized, nonmetastatic, solid tumors.
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Selumetinib Approved in Europe for Pediatric Neurofibromatosis Type 1 and Plexiform Neurofibromas
June 22nd 2021The European Commission has granted a conditional approval to selumetinib for the treatment of pediatric patients with symptomatic, inoperable plexiform neurofibromas and neurofibromatosis type 1 who are at least 3 years of age.
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Frontline Pembrolizumab Plus Chemo With or Without Bevacizumab Improves Survival in Cervical Cancer
June 22nd 2021Pembrolizumab plus platinum-based chemotherapy with or without bevacizumab significantly improved overall survival and progression-free survival over the same platinum-based chemotherapy regimen with or without bevacizumab in patients with persistent, recurrent, or metastatic cervical cancer—irrespective of PD-L1 status.
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Pirtobrutinib Elicits Encouraging Efficacy in CLL, SLL, MCL, & Other Non-Hodgkin Lymphomas
June 21st 2021Pirtobrutinib produced promising efficacy in patients with previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma, those with mantle cell lymphoma and other non-Hodgkin lymphomas, and those who progressed on Richter transformation–directed therapy.
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Zanubrutinib Approved in China for Relapsed/Refractory Waldenström Macroglobulinemia
June 21st 2021The China National Medical Products Administration has granted a conditional approval to zanubrutinib for the treatment of adult patients with Waldenström macroglobulinemia who have previously received at least 1 therapy.
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FDA, EU Approval Sought for Copanlisib Plus Rituximab for Indolent Non-Hodgkin Lymphoma
June 21st 2021A supplemental new drug application and a marketing authorization application seeking the approval of the combination of copanlisib and rituximab for the treatment of patients with indolent non-Hodgkin lymphoma have been submitted to the FDA and the European Medicines Agency, respectively.
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Oral Azacitidine Approved in Europe for Frontline Maintenance in AML
June 18th 2021The European Commission has granted full marketing authorization to azacitidine tablets for use as a maintenance therapy in adult patients with acute myeloid leukemia who achieved complete remission or CR with incomplete blood recovery after induction therapy with or without consolidation treatment, and who are not eligible for, or do not choose to proceed to, hematopoietic stem cell transplant.
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FDA Grants Priority Review to Balstilimab for Recurrent or Metastatic Cervical Cancer
June 17th 2021The FDA has granted priority review to the biologics license application for balstilimab for use in the treatment of patients with recurrent or metastatic cervical cancer who experienced disease progression on, or after, chemotherapy.
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FDA Approves Avapritinib for Advanced Systemic Mastocytosis
June 16th 2021The FDA has approved avapritinib (Ayvakit) for the treatment of adult patients with advanced systemic mastocytosis, including those with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematological neoplasm, and mast cell leukemia.
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LiPax Elicits Encouraging RFS Rate in Non–Muscle Invasive Bladder Cancer
June 16th 2021LiPax, a precision-targeted, locally-delivered taxane, was found to induce a recurrence-free survival rate of 83% in patients with non–muscle invasive bladder cancer who had undergone transurethral resection of bladder tumor.
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eMonarcHER to Examine Abemaciclib Plus Adjuvant Endocrine Therapy in HER2+ Early Breast Cancer
June 14th 2021The safety and efficacy of abemaciclib will be examined in patients with hormone receptor–positive, HER2-positive, node-positive, high-risk early breast cancer who have completed standard adjuvant HER2-targeted treatment as part of the phase 3 eMonarcHER trial.
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Rituximab Biosimilar CT-P10 Demonstrates Real-World Safety, Efficacy in DLBCL
June 14th 2021The rituximab biosimilar CT-P10 produced response and survival rates that were comparable to those previously reported with the reference product, along with acceptable tolerability, in patients with diffuse large B-cell lymphoma.
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Water Vapor Ablation Therapy Shows Encouraging Efficacy, Safety in Prostate Cancer
June 14th 2021A water vapor ablation therapy has been shown to be able to reach and treat all prostate regions and eradicate intermediate risk, grade group 2 prostate cancer with acceptable safety and tolerability.
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Frontline Trastuzumab Deruxtecan Under Exploration With or Without Pertuzumab in HER2+ Breast Cancer
June 14th 2021Fam-trastuzumab deruxtecan-nxki is under investigation with or without pertuzumab vs a standard-of-care regimen comprised of a taxane, trastuzumab, and pertuzumab in the frontline treatment of patients with HER2-positive metastatic breast cancer as part of the phase 3 DESTINY-Breast09 trial.
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Rusfertide Eliminates Need for Phlebotomy, Reverses Iron Deficiency in Polycythemia Vera
June 12th 2021Rusfertide has been shown to be an effective option for patients with polycythemia vera in that it reverses iron deficiency, improves disease-related symptoms, and eliminates the need for therapeutic phlebotomy.
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Oncolytic Virus Teserpaturev Approved in Japan for Malignant Glioma
June 11th 2021The Japan Ministry of Health, Labour, and Welfare has granted conditional and time-limited approval to teserpaturev for the treatment of patients with malignant glioma; this is the first oncolytic virus to receive approval for use in this indication or any primary brain cancer.
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Second-Line Liso-cel Demonstrates Significant Benefit Over SOC in Relapsed/Refractory LBCL
June 10th 2021Lisocabtagene maraleucel demonstrated a highly significant improvement in event-free survival, complete response rate, and progression-free survival over standard of care in the second-line treatment of patients with relapsed/refractory large B-cell lymphoma, meeting primary and secondary end points of the phase 3 TRANSFORM trial.
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FDA Approves Lymphoseek for Pediatric Melanoma, Rhabdomyosarcoma, and Other Solid Tumors
June 10th 2021The FDA approved the radiopharmaceutical agent technetium Tc 99m tilmanocept injection (Lymphoseek) for accurate and precise lymph node identification in pediatric patients with melanoma, rhabdomyosarcoma, and other types of solid tumors.
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Duvelisib Approved in Europe for Relapsed/Refractory CLL or Follicular Lymphoma
June 9th 2021The European Medicines Agency has granted marketing authorization to duvelisib for single-agent use in patients with relapsed/refractory chronic lymphocytic leukemia who have previously received at least 2 therapies or those with follicular lymphoma whose disease is refractory to at least 2 previous systemic therapies.
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FDA Extends Review Period for Ruxolitinib in Chronic GVHD
June 9th 2021The FDA has extended the review period for the supplemental new drug application for ruxolitinib as a therapeutic option for adult and pediatric patients aged 12 years and older with steroid-refractory chronic graft-versus-host disease.
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Trastuzumab Duocarmazine Shows Superiority Over Physician’s Choice for HER2+ Breast Cancer
June 8th 2021The antibody-drug conjugate vic-trastuzumab duocarmazine was found to significantly improve progression-free survival over physician’s choice of treatment in patients with pretreated HER2-positive unresectable locally advanced or metastatic breast cancer, meeting the primary end point of the phase 3 TULIP trial.
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Panitumumab Plus 5-FU/Leucovorin Maintenance Improves PFS in RAS Wild-Type Metastatic CRC
June 8th 2021The addition of panitumumab to 5-fluorouracil and leucovorin significantly improved progression-free survival as a maintenance treatment over 5-FU/leucovorin alone in patients with RAS wild-type metastatic colorectal cancer.
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