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 Issues CRL to BLA for On-Body Injector Presentation of Pegfilgrastim-cbqv
September 25th 2023The FDA has issued a complete response letter to the biologics license application seeking the approval of the on-body injector presentation of pegfilgrastim-cbqv, which is a biosimilar of pegfilgrastim.
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MWTX-003 Wins FDA Fast Track Designation for Polycythemia Vera
September 21st 2023The FDA has granted fast track designation to the investigational, anti-TMPRSS6 monoclonal antibody, MWTX-003 (DISC-3405), for use in the treatment of patients with polycythemia vera, according to an announcement from Disc Medicine, Inc.
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FDA Approval Sought for Frontline Tislelizumab in Locally Advanced or Metastatic ESCC
September 19th 2023The FDA has accepted for review a biologics license application seeking the approval of tislelizumab for use in the frontline treatment of patients with unresectable, recurrent, locally advanced or metastatic esophageal squamous cell carcinoma.
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EMA Grants PRIME Designation to Iopofosine I-131 for Waldenström Macroglobulinemia
September 19th 2023The European Medicines Agency has granted Priority Medicines designation to iopofosine I-131 for use in patients with Waldenström macroglobulinemia in patients who previously received at least 2 treatment regimens.
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Brentuximab Vedotin Plus AVD Gets Positive CHMP Opinion for CD30+ Stage III Hodgkin Lymphoma
September 18th 2023The European Medicine Agency’s Committee for Medicinal Products for Human Use has recommended the approval of brentuximab vedotin in combination with doxorubicin, vinblastine, and dacarbazine in adult patients with previously untreated, CD30-positive, stage III Hodgkin lymphoma.
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Trastuzumab Deruxtecan Receives CHMP Recommendation for Approval in HER2-Mutant NSCLC
September 15th 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended fam-trastuzumab deruxtecan-nxki for use as a single agent in adult patients with HER2-mutated, advanced non–small cell lung cancer who require systemic treatment after platinum-based chemotherapy with or without immunotherapy.
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Extended Melphalan Flufenamide Indication Approaches EU Approval for R/R Multiple Myeloma
September 14th 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion regarding a Type II variation application to extend the therapeutic indication of melphalan flufenamide for use in adult patients with multiple myeloma who have received at least 2 prior lines of treatment and whose disease is refractory to lenalidomide and the last line of therapy.
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FDA Grants Fast Track Status to Tulmimetostat for Endometrial Cancer
September 13th 2023The FDA has granted fast track designation to tulmimetostat for use as a potential therapeutic option in patients with advanced, recurrent, or metastatic endometrial cancer harboring ARID1A mutations and whose disease had progressed on at least 1 prior line of therapy.
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Iruplinalkib Improves PFS Vs Crizotinib in Locally Advanced or Metastatic ALK+ NSCLC
September 10th 2023Treatment with iruplinalkib significantly improved progression-free survival and produced a higher objective response rate compared with crizotinib in patients with ALK TKI–naïve, locally advanced and metastatic ALK-positive non–small cell lung cancer, according to data from a prespecified interim analysis of the phase 3 INSPIRE trial.
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Frontline Benmelstobart Plus Anlotinib/Chemo Improves Survival Vs Placebo in ES-SCLC
September 10th 2023The addition of benmelstobart to anlotinib and etoposide plus carboplatin significantly improved progression-free survival and overall survival over placebo plus etoposide plus carboplatin when used in the first-line treatment of patients with extensive-stage small cell lung cancer.
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Subcutaneous Epcoritamab Elicits Durable Responses in Relapsed/Refractory LBCL
September 8th 2023Subcutaneous epcoritamab produced deep and durable complete remissions in patients with relapsed or refractory large B-cell lymphoma, with complete responders having favorable long-term outcomes, according to updated data from the phase 1/2 EPCORE NHL-1 trial.
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Early Cytogenetic or Molecular Landmark Response to Ponatinib Predicts Outcomes in CP-CML
September 7th 2023Early cytogenetic and molecular responses achieved with ponatinib was significantly linked with better long-term progression-free survival and overall survival in patients with highly resistant, pretreated chronic-phase chronic myeloid leukemia.
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Acalabrutinib Approved in China for Chronic Lymphocytic Leukemia
September 5th 2023The National Medical Products Administration in China has approved acalabrutinib for use in adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have previously received at least 1 therapy.
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Repotrectinib Gets Breakthrough Therapy Designation in China for NTRK+ TKI-Pretreated Solid Tumors
August 30th 2023The Center for Drug Evaluation, of the National Medical Products Administration in China, has granted breakthrough therapy designation to repotrectinib for use in patients with advanced solid tumors harboring a NTRK gene fusion who experienced disease progression after TKI treatment.
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Savolitinib Wins Breakthrough Therapy Designation in China for Gastric Cancer With MET Amplification
August 30th 2023The Center for Drug Evaluation, of the National Medical Products Administration in China, has granted a breakthrough therapy designation to savolitinib for use in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction with MET amplification in whom at least 2 lines of standard therapy have failed.
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Subcutaneous Atezolizumab Approved in Great Britain for All Intravenous Indications
August 29th 2023Great Britain’s Medicines and Healthcare Products Regulatory Agency has approved subcutaneous atezolizumab for all indications in which the intravenous formulation of the drug has been approved, including select types of lung, bladder, breast, and liver cancers.
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FDA Approves Luspatercept for First-line Treatment of Anemia in Lower-Risk MDS
August 29th 2023The FDA has approved luspatercept-aamt (Reblozyl) for the treatment of anemia without prior erythropoiesis stimulating agent (ESA) use in adult patients with very low– to intermediate-risk myelodysplastic syndrome (MDS) who may require regular red blood cell (RBC) transfusions.
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FDA Grants Fast Track Status to ALE.C04 for Recurrent or Metastatic CLDN1+ HNSCC
August 25th 2023The FDA has granted fast track designation to ALE.C04 for use as a potential therapeutic option in patients with recurrent or metastatic, Claudin-1–positive head and neck squamous cell carcinomas.
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FDA Approval Sought for Amivantamab Plus Chemo in EGFR Exon 20 Insertion+ NSCLC
August 25th 2023A supplemental biologics license application seeking the expanded approval of amivantamab-vmjw in combination with carboplatin plus pemetrexed for use in the frontline treatment of patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations has been submitted to the FDA.
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Sunvozertinib Approved in China for NSCLC With EGFR Exon 20 Insertion Mutations
August 23rd 2023The National Medical Products Administration of China has approved sunvozertinib for use in adult patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations whose disease has progressed on or following platinum-based chemotherapy.
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Trastuzumab Deruxtecan Approved in Japan for HER2-Mutated Metastatic NSCLC
August 23rd 2023Japan’s Ministry of Health, Labour, and Welfare has approved fam-trastuzumab deruxtecan-nxki for use in adult patients with unresectable advanced or recurrent, HER2-mutant non–small cell lung cancer that has progressed following chemotherapy.
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FDA Grants Priority Review to Enzalutamide for nmCSPC With High-Risk Biochemical Recurrence
August 23rd 2023The FDA has accepted and granted priority review to a supplemental new drug application seeking the approval of enzalutamide in patients with nonmetastatic castration-sensitive prostate cancer with high-risk biochemical recurrence.
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