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 Green Lights Companion Diagnostic for Avapritinib in Gastrointestinal Stromal Tumors
August 8th 2023The FDA has approved the therascreen PDGFRA RGQ PCR kit for use as a companion diagnostic, co-developed by Qiagen and Blueprint Medicines, to assist in the identification of patients with gastrointestinal stromal tumors who may be candidates to receive avapritinib.
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Selpercatinib Meets PFS End Point in Newly Diagnosed Advanced or Metastatic RET+ NSCLC
August 4th 2023Selpercatinib significantly improved progression-free survival vs platinum-based chemotherapy plus pemetrexed and pembrolizumab in patients with advanced or metastatic non–small cell lung cancer harboring RET fusions.
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Batiraxcept Plus Paclitaxel Misses PFS End Point in Platinum-Resistant Ovarian Cancer
August 3rd 2023The addition of batiraxcept to paclitaxel did not significantly improve progression-free survival compared with paclitaxel alone in a prespecified subset of patients with platinum-resistant ovarian cancer who were not previously exposed to bevacizumab, missing the primary end point of the phase 3 AXLerate-OC trial.
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The FDA has approved trifluridine and tipiracil (Lonsurf) plus bevacizumab (Avastin) for patients with metastatic colorectal cancer who were previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; a VEGF inhibitor; and an EGFR inhibitor, if they have RAS wild-type disease.
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FDA Approves Dostarlimab Plus Chemo for dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer
July 31st 2023The FDA has approved dostarlimab-gxly (Jemperli) in combination with carboplatin and paclitaxel, followed by dostarlimab as a monotherapy in adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient, as determined by an FDA-approved test, or microsatellite instability high.
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FDA Issues Complete Response Letter to Denileukin Diftitox for R/R Cutaneous T-cell Lymphoma
July 31st 2023The FDA has issued a complete response letter to the biologics license application seeking approval of denileukin diftitox for use in patients with relapsed or refractory cutaneous T-cell lymphoma following at least 1 previous systemic therapy.
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NKX019 Showcases Manageable Safety, Early Activity in R/R B-cell Non-Hodgkin Lymphoma
July 27th 2023The allogeneic natural killer cell therapy NKX019 was found to have an acceptable toxicity profile and to induce deep and durable responses in patients with relapsed or refractory B-cell non-Hodgkin lymphomas.
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Teclistamab Snags Positive CHMP Opinion for Relapsed/Refractory Multiple Myeloma
July 21st 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of a Type II variation for teclistamab in the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior therapies.
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CHMP Recommends Talquetamab Monotherapy for R/R Multiple Myeloma
July 21st 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended conditional marketing authorization of talquetamab for use as a single agent in adult patients with relapsed or refractory multiple myeloma who have previously received at least 3 therapies.
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FDA Awards Fast Track Designation to ARX517 for Metastatic Castration-Resistant Prostate Cancer
July 20th 2023The FDA has granted fast track designation to ARX517 for use as a potential treatment option in patients with metastatic castration-resistant prostate cancer who experience disease progression on an androgen receptor pathway inhibitor.
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Bexmarilimab Plus SOC Continues to Show Early Activity in R/R AML and MDS
July 19th 2023Bexmarilimab in combination with standard-of-care azacitidine or azacitidine plus venetoclax demonstrated early signs of efficacy in patients with relapsed or refractory acute myeloid leukemia and myelodysplastic syndrome.
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Theseus Pharmaceuticals Terminates Development of THE-630 in Gastrointestinal Stromal Tumors
July 19th 2023Theseus Pharmaceuticals has announced that the development of THE-630 as a potential therapeutic option for patients with gastrointestinal stromal tumor has been terminated, and enrollment to the ongoing phase 1/2 trial evaluating the agent’s safety and efficacy in this population has been discontinued.
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FDA Grants Fast Track Status to Selinexor for Myelofibrosis
July 19th 2023The FDA has granted a fast track designation to selinexor for use in the treatment of patients with myelofibrosis, including primary myelofibrosis, post–essential thrombocytopenia myelofibrosis, and post–polycythemia vera myelofibrosis.
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Olaparib Monotherapy Showcases Antitumor Activity in BAP1-mutated RCC
July 14th 2023Olaparib monotherapy elicited responses with favorable tolerability in patients with renal cell carcinoma whose tumors harbored BAP1 or other DNA repair gene mutations, according to data from the interim analysis of the phase 2 ORCHID trial presented during the 2023 Kidney Cancer Research Summit.
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Trastuzumab Deruxtecan Approved in China for HER2-Low Metastatic Breast Cancer
July 12th 2023China’s National Medical Products Administration has approved trastuzumab deruxtecan monotherapy in adult patients with unresectable or metastatic HER2-low breast cancer who have previously received a systemic therapy in the metastatic setting or whose disease recurred during or within 6 months of adjuvant chemotherapy.
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Fixed-Duration Glofitamab Approved in Europe for Relapsed/Refractory DLBCL
July 11th 2023The European Commission has granted conditional marketing authorization to glofitamab for fixed-duration administration in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following 2 or more lines of systemic treatment.
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THIO Followed by Cemiplimab Shows Early Promise in Advanced NSCLC
July 10th 2023The sequential combination of 6-thio-2’-deoxyguanosine and cemiplimab provided a progression-free survival benefit in the first 2 patients with advanced non–small cell lung cancer enrolled to the part A safety lead-in portion of the phase 2 THIO-101 trial.
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Equecabtagene Autoleucel Approved in China for Relapsed/Refractory Multiple Myeloma
July 7th 2023China’s National Medical Products Administration has approved the new drug application for equecabtagene autoleucel for the treatment of adult patients with relapsed or refractory multiple myeloma who previously received 3 or more lines of therapy, including a proteasome inhibitor and an immunomodulatory drug.
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Botensilimab Plus Balstilimab Provides OS Benefit in Heavily Pretreated MSS mCRC
July 5th 2023The combination of botensilimab and balstilimab elicited durable responses and provided overall survival benefits in patients with microsatellite stable metastatic colorectal cancer that is resistant to chemotherapy and/or immunotherapy.
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huCART19-IL8 Proves Safe and Elicits Durable Responses in CAR T–Pretreated R/R Lymphoma
July 3rd 2023huCART19-IL8 had acceptable safety and induced durable responses in patients with lymphoma who were refractory or relapsed following second-generation CD19-targeted CAR T-cell therapies, according to data from a first-in-human phase 1 trial.
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FDA Grants Breakthrough Therapy Designation to Zenocutuzumab for NRG1+ Pancreatic Cancer
June 30th 2023The FDA has granted breakthrough therapy designation to zenocutuzumab for use as a potential therapeutic option in patients with advanced unresectable or metastatic NRG1 fusion–positive pancreatic cancer after disease progression on previous systemic therapy or who have no satisfactory alternative options available.
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FDA Grants Fast Track Status to Quaratusugene Ozeplasmid Plus Atezolizumab in ES-SCLC
June 29th 2023The FDA has granted fast track designation to the combination of quaratusugene ozeplasmid and atezolizumab as maintenance therapy in patients with extensive-stage small cell lung cancer whose disease did not progress after receiving initial standard treatment with atezolizumab and chemotherapy.
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