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
Gilteritinib/Azacitidine Fails to Significantly Improve OS in Newly Diagnosed FLT3+ AML
December 21st 2020December 21, 2020 — The addition of gilteritinib to azacitidine failed to significantly improve overall survival vs azacitidine alone in patients with newly diagnosed FLT3-mutated acute myeloid leukemia who were not eligible for intensive induction chemotherapy, failing to meet the primary end point of the LACEWING trial.
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BLA Initiated for JZP-458 in Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
December 21st 2020December 21, 2020 - The submission of a biologics license application to the FDA has been initiated for JZP-458 for use as a component of a multiagent chemotherapy regimen in the treatment of adult and pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma.
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FDA Approval Sought for Cilta-Cel in Relapsed/Refractory Multiple Myeloma
December 21st 2020December 21, 2020 - A rolling submission of the biologics license application for the BCMA-directed CAR T-cell product ciltacabtagene autoleucel for use in adults with relapsed/refractory multiple myeloma has been initiated to the FDA.
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FDA Approves Adjuvant Osimertinib for EGFR+ NSCLC
December 18th 2020December 18, 2020 - The FDA has approved osimertinib for use as an adjuvant treatment following tumor resection in patients with non–small cell lung cancer whose tumors harbor EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
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FDA Approves Selinexor Plus Bortezomib/Dexamethasone for Multiple Myeloma Following 1 Prior Therapy
December 18th 2020December 18, 2020 - The FDA has approved selinexor in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 1 previous therapy.
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FDA Advisory Committee Votes in Favor of COVID-19 Vaccine mRNA-1273
December 17th 2020December 17, 2020 - The FDA’s Vaccines and Related Biological Products Advisory Committee has voted 20-0 with 1 abstention to support the benefit-risk profile associated with the coronavirus disease 2019 vaccine mRNA-1273.
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FDA Approves Rituximab Biosimilar for NHL, CLL, GPA, and MPA
December 17th 2020December 17, 2020 - The FDA has approved rituximab-arrx, a biosimilar to rituximab, for the treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.
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December 17, 2020 - The FDA has granted priority review to a new supplemental biologics license application for pembrolizumab in combination with platinum- and fluoropyrimidine-based chemotherapy as a first-line treatment in patients with locally advanced unresectable or metastatic esophageal and gastroesophageal junction cancer.
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KTE-X19 Approved in Europe for Relapsed/Refractory MCL
December 17th 2020December 17, 2020 — The European Commission has granted a conditional marketing authorization to the CD19-targeted CAR T-cell therapy KTE-X19 for use in adult patients with relapsed or refractory mantle cell lymphoma who had previously received 2 or more lines of systemic therapy including a BTK inhibitor.
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FDA Approval Sought for Sotorasib for KRAS G12C–Mutated Advanced or Metastatic NSCLC
December 17th 2020December 16, 2020 - A new drug application has been submitted to the FDA for sotorasib for the treatment of patients with KRAS G12C–mutant locally advanced or metastatic non–small cell lung cancer, as determined by an FDA-approved test, after at least 1 previous systemic therapy.
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FDA Approves Margetuximab-cmkb Plus Chemo in Pretreated Metastatic HER2+ Breast Cancer
December 16th 2020December 16, 2020 - The FDA has approved margetuximab-cmkb plus chemotherapy for use in adult patients with metastatic HER2-positive breast cancer who have previously received 2 or more anti-HER2 regimens, at least one of which was for metastatic disease.
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Second-Line Motixafortide Plus Pembrolizumab/Chemo Substantially Improves Survival in Stage IV PDAC
December 16th 2020December 16, 2020 - The combination of motixafortide plus pembrolizumab and chemotherapy was found to result in a substantial improvement in overall survival, progression-free survival, and overall response rate when used as a second-line treatment in patients with stage IV pancreatic ductal adenocarcinoma.
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Giant of Cancer Care® Eric Winer Elected ASCO President for 2022-2023 Term
December 16th 2020December 16, 2020 - Eric P. Winer, MD, FASCO, 2019 OncLive Giants of Cancer Care® recipient in Breast Cancer, has been elected to serve as the president of ASCO for the 2022-2023 term, and will assume the president-elect position during the 2020 ASCO Annual Meeting.
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Trastuzumab Deruxtecan Approaches EU Approval for HER2+ Metastatic Breast Cancer
December 15th 2020December 15, 2020 - The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for fam-trastuzumab deruxtecan-nxki for use as a single agent in adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received 2 or more anti-HER2–based regimens.
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Fixed-Dose Durvalumab Nears EU Approval for Unresectable NSCLC
December 15th 2020December 15, 2020 - The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for an additional dosing option of durvalumab, a fixed dose of 1500 mg every 4 weeks, in the approved indication of locally advanced, unresectable non–small cell lung cancer in adults whose tumors have a PD-L1 expression of at least 1% and who did not have progressive disease after platinum-based chemoradiation treatment.
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Tumor Growth Rate Associated With Outcomes in Sarcoma Treated With Immunotherapy or Targeted Therapy
December 14th 2020December 14, 2020 — A link between tumor growth rate and clinical outcomes was established in patients with sarcoma who received treatment with immunotherapy or targeted therapy.
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December 11, 2020 - The European Medicine Agency’ s Committee for Medicinal Products for Human Use has granted a positive opinion to avelumab as a single agent, frontline maintenance option for adult patients with locally advanced or metastatic urothelial carcinoma who are free of disease progression after platinum-based chemotherapy.
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EU Panel Recommends Tucatinib for Locally Advanced or Metastatic HER2+ Breast Cancer
December 11th 2020December 11, 2020 - The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion to tucatinib in combination with trastuzumab and capecitabine for use in adult patients with HER2-positive, locally advanced or metastatic breast cancer who had received at least 2 previous anti-HER2 therapies.
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Frontline Pembrolizumab Granted Positive EU Opinion in Metastatic MSI-H, dMMR CRC
December 11th 2020December 11, 2020 - The European Medicine Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for pembrolizumab monotherapy for the frontline treatment of adult patients with metastatic microsatellite instability–high or mismatch repair deficient colorectal cancer.
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FDA Advisory Committee Votes in Favor of COVID-19 Vaccine BNT162b2
December 10th 2020December 10, 2020 - The FDA's Vaccines and Related Biological Products Advisory Committee has voted 17-4 with 1 abstention to support the benefit-risk profile associated with the coronavirus disease 2019 vaccine BNT162b2.
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Sacituzumab Govitecan Induces Clinical Benefit in Metastatic TNBC, Irrespective of Trop-2 Expression
December 10th 2020December 10, 2020 - The antibody-drug conjugate sacituzumab govitecan was found to induce clinical benefit over physician’s choice of therapy in patients with metastatic triple-negative breast cancer, irrespective of Trop-2 expression; however, greater efficacy was observed in those who had a medium or high Trop-2 score.
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