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
Pembrolizumab Approved in Japan for Select Breast Cancer and Colorectal Cancer
August 26th 2021The Japan Pharmaceuticals and Medical Devices Agency has approved the use of pembrolizumab in the treatment of patients with PD-L1–positive, hormone receptor–negative and HER2-negative, inoperable or recurrent breast cancer, and for single-agent use in patients with unresectable, advanced, or recurrent microsatellite instability–high colorectal cancer.
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FDA Green Lights Companion Diagnostic for Ivosidenib in IDH1-Mutant Cholangiocarcinoma
August 26th 2021The FDA has approved the Oncomine Dx Target Test, developed by Thermo Fisher Scientific, for use as a companion diagnostic to identify patients with IDH1-mutated cholangiocarcinoma who may be eligible to receive the newly approved IDH1 inhibitor ivosidenib.
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Roxadustat Shows Activity Against Chemotherapy-Induced Anemia in Non-Myeloid Malignancies
August 26th 2021The first-in-class small molecule HIF-PHI inhibitor roxadustat demonstrated promising efficacy with favorable tolerability when used in the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies, meeting the primary end point of the phase 2 WHITNEY trial.
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Silmitasertib Gets Fast Track Status for Recurrent Sonic Hedgehog–Driven Medulloblastoma
August 25th 2021The FDA has granted a fast track designation to the highly selective CK2 inhibitor silmitasertib as a potential therapeutic option for patients with recurrent sonic hedgehog–driven medulloblastoma
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Phase 2 Trial of Bintrafusp Alfa in Frontline Biliary Tract Cancer Discontinued
August 24th 2021Merck KGaA, Darmstadt, Germany has decided to discontinue the phase 2 INTR@PID BTC 055 trial examining bintrafusp alfa plus gemcitabine and cisplatin in the frontline treatment of patients with locally advanced or metastatic biliary tract cancer.
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Second-Line Tisagenlecleucel Misses EFS End Point in Aggressive B-cell Non-Hodgkin Lymphoma
August 24th 2021The CAR T-cell therapy tisagenlecleucel did not significantly improve event-free survival compared with standard of care when used in the second-line treatment of patients with aggressive B-cell non-Hodgkin lymphoma who had primary refractory disease or who relapsed within 12 months of frontline treatment.
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FDA Issues Warning on Utilization of Robotically-Assisted Surgical Devices in Mastectomy
August 24th 2021The FDA issued an updated safety communication to remind the community that the safety and effectiveness of robotically-assisted surgical devices for use in mastectomy procedures or in the prevention or treatment of patients with breast cancer have not been established.
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NCCN Calls for Mandatory COVID-19 Vaccination for Healthcare Workers
August 23rd 2021The National Comprehensive Cancer Center Network has issued an official statement calling on all healthcare systems to ensure that their workforces are immunized with one of the authorized COVID-19 vaccines.
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Off-the-Shelf NK Cell Products FT596 and FT516 Show Early Promise in B-cell Lymphoma
August 23rd 2021Regimens that included the off-the-shelf, induced pluripotent stem cell–derived natural killer cell products FT596 and FT516 were found to elicit encouraging responses with favorable tolerability when used in patients with B-cell lymphoma.
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FDA Grants Priority Review to Abatacept for Prevention of Acute GVHD
August 23rd 2021The FDA has granted a priority review designation to a supplemental biologics license application seeking the approval of abatacept for the prevention of moderate to severe acute graft-versus-host disease in patients aged 6 years and older who are receiving unrelated donor hematopoietic stem cell transplantation.
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FDA Approves Adjuvant Nivolumab for High-Risk Urothelial Carcinoma
August 20th 2021The FDA has approved nivolumab for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection, irrespective of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status.
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Toripalimab Plus Chemo Meets PFS End Point in Frontline Advanced NSCLC
August 19th 2021The addition of toripalimab to chemotherapy resulted in a significant improvement in progression-free survival compared with chemotherapy alone when given as first-line treatment in patients with non–small cell lung cancer, meeting the primary end point of the phase 3 CHOICE-01 trial.
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Idecabtagene Vicleucel Approved in Europe for Relapsed/Refractory Multiple Myeloma
August 19th 2021The European Commission has granted a conditional marketing authorization for idecabtagene vicleucel for use in adult patients with relapsed/refractory multiple myeloma who have previously received at least 3 therapies, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody and progressed on their last therapy.
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FDA Green Lights First Companion Diagnostic for Dostarlimab in dMMR Solid Tumors
August 18th 2021The FDA has approved the VENTANA MMR RxDx panel as the first companion diagnostic test to assist in identifying patients with solid tumors that are DNA mismatch repair deficient who may be eligible to receive the anti–PD-1 therapy dostarlimab-gxly, which was recently granted an accelerated approval by the agency.
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FDA Grants Fast Track Designation to STRO-002 for Advanced Ovarian Cancer
August 18th 2021The FDA has granted a fast track designation to STRO-002 as a potential therapeutic option for patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have previously received 1 to 3 lines of systemic therapy.
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FDA Approves Dostarlimab-gxly for dMMR Recurrent or Advanced Solid Tumors
August 17th 2021The FDA has granted an accelerated approval to dostarlimab-gxly for the treatment of adult patients with mismatch repair-deficient recurrent or advanced solid tumors, as determined by an FDA-approved test, who have progressed on or following previous treatment and who have no satisfactory alternative options.
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EMA Validates Applications for Nivolumab/Ipilimumab, Nivolumab/Chemo in Frontline ESCC
August 17th 2021The European Medicines Agency has validated its Type II Variation Marketing Authorization Applications for nivolumab plus ipilimumab and nivolumab plus fluoropyrimidine- and platinum-containing chemotherapy as frontline options for adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma.
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COVID-19 vaccination has been shown to induce high rates of seroconversion in patients with cancer, although those with hematologic malignancies have demonstrated lower immunogenicity and those who previously received immunosuppressive therapies appear to be less responsive.
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Sintilimab/Chemo Improves OS in Frontline Advanced or Metastatic Gastric or GEJ Adenocarcinoma
August 16th 2021Sintilimab plus oxaliplatin/capecitabine significantly improved overall survival over chemotherapy alone when used as a first-line treatment in patients with unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.
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FDA Issues a Complete Response Letter for Vicineum for High-Risk, BCG-Unresponsive NMIBC
August 16th 2021The FDA has issued a complete response letter to Sesen Bio regarding its biologics license application for Vicineum for the treatment of patients with Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer.
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