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
Leveraging CDK4/6 Inhibitors in Earlier Settings to Boost Outcomes in HR+ Breast Cancer
July 17th 2020Angela DeMichele, MD, MSCE, shares how to utilize available data with CDK4/6 inhibitors in the neoadjuvant and adjuvant settings to optimize outcomes for patients with hormone receptor–positive breast cancer.
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Liso-Cel Takes Step Toward EU Approval in B-Cell Lymphomas
July 17th 2020The European Medicines Agency has validated a Marketing Authorization Application for the CD19-directed CAR T-cell therapy lisocabtagene maraleucel for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and grade 3B follicular lymphoma following at least 2 prior therapies.
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Adjuvant T-DM1/Pertuzumab Combo Misses iDFS End Point in High-Risk HER2-Positive Breast Cancer
July 16th 2020Anthracycline-based chemotherapy followed by ado-trastuzumab emtansine plus pertuzumab did not show statistically significant or clinically meaningful improvement in invasive disease-free survival in patients with high-risk HER2-positive early breast cancer, missing the primary end point of the phase 3 KAITLIN trial.
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Data Monitoring Committee Recommends Potential Stop of OPTIMA Trial in HCC
July 13th 2020The independent data monitoring committee has recommended that Celsion Corporation consider stopping the global, phase 3 OPTIMA trial examining ThermoDox® in combination with radiofrequency ablation for the treatment of patients with hepatocellular carcinoma.
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Phase 3 IMagyn050 Trial in Ovarian Cancer Does Not Meet Primary End Point of PFS
July 13th 2020Results from the phase 3 IMagyn050 trial showed that the addition of atezolizumab to bevacizumab, paclitaxel, and carboplatin did not meet the primary end point of progression-free survival for first-line treatment of women with newly diagnosed, advanced ovarian cancer.
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F-627 Shows Strong, Durable Benefit in Chemotherapy-Induced Neutropenia in Breast Cancer
July 9th 2020Efbemalenograstim alpha (F-627) has demonstrated strong and lasting benefit when used as a treatment for chemotherapy-induced neutropenia in patients with breast cancer, meeting the primary and secondary end points of a phase 3 study.
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NICE Recommends Frontline Brentuximab Vedotin Combo for Systemic Anaplastic Large Cell Lymphoma
July 9th 2020The United Kingdom’s National Institute for Health and Care Excellence has recommended brentuximab vedotin (Adcetris) in combination with cyclophosphamide, doxorubicin, and prednisone as a treatment option in treatment-naïve patients with systemic anaplastic large cell lymphoma.
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FDA Grants Priority Review to Second-Line Pembrolizumab in Relapsed/Refractory Hodgkin Lymphoma
July 9th 2020The FDA has granted priority review to a new supplemental biologics license application for pembrolizumab monotherapy as a treatment for adult patients with relapsed/refractory classical Hodgkin lymphoma.
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FDA Issues Complete Response Letter for Pembrolizumab/Lenvatinib in First-Line HCC
July 8th 2020The FDA has issued a complete response letter to Merck and Eisai stating that it will not approve the applications that are seeking the accelerated approval of pembrolizumab in combination with lenvatinib for the frontline treatment of patients with unresectable hepatocellular carcinoma.
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Dexamethasone: A Potential Gamechanger in the Fight Against COVID-19?
July 8th 2020Research efforts have revealed a potential weapon to add to the treatment arsenal against COVID-19, a drug that has historically played a crucial role in oncology treatment: the inexpensive, and widely accessible, corticosteroid dexamethasone.
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Sacituzumab Govitecan Meets Primary End Point in Phase 3 ASCENT Trial
July 6th 2020The novel antibody-drug conjugate sacituzumab govitecan-hziy demonstrated significant improvement in survival in patients with triple-negative breast cancer without brain metastases who previously received at least 2 prior therapies for metastatic disease.
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FDA Approval Sought for Pralsetinib in Advanced RET+ Thyroid Cancers
July 2nd 2020A new drug application has been submitted to the FDA for pralsetinib (BLU-667) for the treatment of patients with advanced or metastatic RET-mutant medullary thyroid cancer and RET fusion–positive thyroid cancers.
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Frontline NALIRIFOX Regimen Shows Promising Activity, Tolerability in Pancreatic Cancer
July 1st 2020The regimen of liposomal irinotecan plus 5-fluorouracil/leucovorin plus oxaliplatin demonstrated a tolerable safety profile with promising antitumor activity when used as frontline treatment in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma.
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FDA Approves Avelumab as Frontline Maintenance in Metastatic Urothelial Carcinoma
July 1st 2020The FDA has approved avelumab (Bavencio) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-based chemotherapy.
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Pivotal Phase 3 CONTACT-02 Trial of Cabozantinib/Atezolizumab in mCRPC Initiated
June 30th 2020Exelixis, Inc. has launched the phase 3 CONTACT-02 trial examining cabozantinib in combination with atezolizumab in patients with metastatic castration-resistant prostate cancer who have received prior treatment with 1 novel hormonal therapy.
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Rolling BLA Submitted to FDA for Omburtamab in Pediatric Metastatic Neuroblastoma
June 30th 2020A biologics license application has been submitted to the FDA for omburtamab, previously referred to as burtomab, for the treatment of pediatric patients with central nervous system/leptomeningeal metastases from neuroblastoma.
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FDA Approval Sought for Melphalan Flufenamide in Triple-Class Refractory Myeloma
June 30th 2020A new drug application has been submitted to the FDA seeking an accelerated approval for melphalan flufenamide in combination with dexamethasone in the treatment of adult patients with triple-refractory multiple myeloma.
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Tisotumab Vedotin Shows Favorable Activity in Recurrent or Metastatic Cervical Cancer
June 30th 2020The antibody-drug conjugate tisotumab vedotin induced clinically meaningful and durable responses in patients who have relapsed or progressed on or after previous treatment for recurrent or metastatic cervical cancer.
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FDA Approves First-Line Pembrolizumab for MSI-H/dMMR Metastatic Colorectal Cancer
June 29th 2020The FDA has approved pembrolizumab (Keytruda) for the first-line treatment of patients with unresectable or metastatic microsatellite instability–high or mismatch repair deficient colorectal cancer.
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FDA Approves Fixed-Dose Pertuzumab/Trastuzumab Combo in HER2+ Breast Cancer
June 29th 2020The FDA has approved a fixed-dose combination of pertuzumab (Perjeta) and trastuzumab (Herceptin) with hyaluronidase, administered via subcutaneous injection in combination with intravenous chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer.
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European Panel Recommends Against Pexidartinib for Tenosynovial Giant Cell Tumor
June 27th 2020The European Medicines Agency’s advisory group, the Committee for Medicinal Products for Human Use, has recommended against the acceptance of the marketing authorization for pexidartinib (Turalio) for the treatment of patients with tenosynovial giant cell tumor.
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Bevacizumab Biosimilar Aybintio Receives Positive European Opinion
June 26th 2020The Committee for Medicinal Products for Human Use has recommended approval of Aybintio, a bevacizumab (Avastin) biosimilar for the treatment of patients with the same types of cancer for which the reference product is indicated in the European Union.
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