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
Radiotherapy Can Be Safely Omitted in PMBCL With CMR After Chemoimmunotherapy
June 10th 2023Although the event rate did reach the expected level and longer follow-up is needed to adequately assess long-term toxicities, data from the phase 3 IELSG37 trial support the omission of radiotherapy in patients with primary mediastinal large B-cell lymphoma who achieve a complete metabolic response following chemoimmunotherapy.
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DaraVCD Elicits Responses in Multiple Myeloma With Extramedullary Disease
June 9th 2023The combination of daratumumab plus bortezomib, cyclophosphamide, and dexamethasone, elicited a complete response (CR) rate of 40% and a CR or better rate of 43% in patients with multiple myeloma presenting with extramedullary disease.
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FDA Lifts Partial Clinical Hold on Phase 1 Trial of MT-0169 in Multiple Myeloma, Hodgkin Lymphoma
June 8th 2023The FDA has removed a partial clinical hold that had been placed on a phase 1 trial investigating the safety and efficacy of MT-0169 as a potential therapeutic option in patients with relapsed or refractory multiple myeloma or non-Hodgkin lymphoma.
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FDA Approval Sought for Pembrolizumab Plus Chemotherapy in Biliary Tract Cancer
June 8th 2023The FDA has accepted for review a supplemental biologics license application seeking the approval of pembrolizumab plus standard chemotherapy comprised of gemcitabine and cisplatin for use in patients with locally advanced unresectable or metastatic biliary tract cancer.
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Neoadjuvant Durvalumab Plus Chemo Improves pCR Vs Chemo Alone in Gastric and GEJ Cancers
June 8th 2023The addition of durvalumab to standard neoadjuvant chemotherapy significantly improved pathologic complete response over neoadjuvant chemotherapy alone in patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers.
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FDA Extends Review Period for Nirogacestat NDA in Desmoid Tumors
June 8th 2023The FDA has extended the Prescription Drug User Fee Act decision date by 3 months to allow more time to complete their review of the new drug application seeking the approval of nirogacestat in the treatment of adult patients with desmoid tumors.
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FDA Approval Sought for Cilta-cel in Relapsed and Lenalidomide-Refractory Multiple Myeloma
June 7th 2023A supplemental biologics license application seeking the approval of ciltacabtagene autoleucel for use in adult patients with relapsed and lenalidomide-refractory multiple myeloma who have previously received at least 1 line of therapy, including a proteasome inhibitor and an immunomodulatory agent, has been submitted to the FDA.
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FDA Grants Priority Review to Dostarlimab Plus Chemo for dMMR/MSI-H Endometrial Cancer
June 6th 2023The FDA has accepted and granted priority review to a supplemental biologics license application seeking the approval of dostarlimab plus chemotherapy for use in adult patients with mismatch repair–deficient/microsatellite instability–high primary advanced or recurrent endometrial cancer.
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ABBV-011 Showcases Early Tolerability, Antitumor Activity in Small Cell Lung Cancer
June 5th 2023The SEZ6-targeted antibody-drug conjugate ABBV-011, when administered at 1 mg/kg every 3 weeks, was found to be well tolerated and to demonstrate early efficacy in patients with relapsed or refractory small cell lung cancer.
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Preoperative FOLFOX Is Noninferior to Preoperative Chemoradiation in Locally Advanced Rectal Cancer
June 4th 2023Neoadjuvant treatment with fluorouracil, leucovorin, and oxaliplatin proved to be as effective as pelvic chemoradiation with fewer adverse effects in patients with locally advanced rectal cancer who were eligible for sphincter-sparing surgery.
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BI 764532 Shows Early Efficacy, Manageable Tolerability in DLL3+ SCLC and Neuroendocrine Carcinoma
June 4th 2023When administered at doses of 90 μg/kg or higher, the novel DLL3-targeting T-cell engager, BI 764532, was found to have an acceptable toxicity profile and to elicit encouraging responses in patients with DLL3-positive small cell lung cancer and neuroendocrine carcinoma.
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Retrospective Study Confirms Real-World Efficacy of Brexucabtagene Autoleucel in R/R B-ALL
June 2nd 2023Brexucabtagene autoleucel elicited high rates of complete remission with minimal residual disease negativity in real-world patients with relapsed or refractory B-cell acute lymphoblastic leukemia who received the CAR T-cell product as post-approval, standard-of-care treatment, according to data from a retrospective study.
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EMA Committee Recommends Piflufolastat 18F PSMA PET Imaging Agent for Prostate Cancer
June 1st 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of piflufolastat 18F, a prostate-specific membrane antigen–targeted positron emission tomography imaging agent, for use in prostate cancer detection.
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Olverembatinib Recommended for Breakthrough Therapy Designation in China for SDH-Deficient GIST
June 1st 2023The China National Medical Products Adminstration’s Center for Drug Evaluation has recommended that olverembatinib receive breakthrough therapy designation for the treatment of patients with gastrointestinal stromal tumor that is succinate dehydrogenase deficient.
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FDA Approves Olaparib/Abiraterone Combo for BRCA+ Metastatic Castration-Resistant Prostate Cancer
May 31st 2023The FDA has approved olaparib (Lynparza) plus abiraterone acetate (Zytiga) and prednisone or prednisolone for the treatment of patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, as determined by an FDA-approved companion diagnostic test.
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FDA Approves First Radiohybrid PSMA-targeted PET Imaging Agent for Prostate Cancer
May 30th 2023The FDA has approved flotufolastat F 18 injection (Posluma) for positron emission tomography of prostate-specific membrane antigen–positive lesions in men with prostate cancer with suspected metastasis who are eligible for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen level.
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European Approval Sought for Cilta-cel in Relapsed and Lenalidomide-Refractory Myeloma
May 26th 2023A Type II variation application seeking the approval of ciltacabtagene autoleucel in adult patients with relapsed and lenalidomide-refractory multiple myeloma has been submitted to the European Medicines Agency.
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Quizartinib Garners Approval in Japan for Newly Diagnosed FLT3-ITD+ AML
May 26th 2023Japan’s Ministry of Health, Labour, and Welfare has approved quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation and as maintenance monotherapy in patients with newly diagnosed acute myeloid leukemia whose tumors harbor FLT3-ITD mutations.
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China’s NMPA Accepts sNDA for Toripalimab Plus Chemo in Advanced TNBC
May 23rd 2023The National Medical Products Administration has accepted the supplemental new drug application seeking the approval of toripalimab in combination with nab-paclitaxel in patients with untreated metastatic or recurrent triple-negative breast cancer and a PD-L1 combined positive score of at least 1.
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FDA Grants Priority Review to Lumisight Optical Imaging Agent for Breast Cancer Detection
May 23rd 2023The FDA has granted priority review to a new drug application seeking the approval of the optical imaging agent Lumisight for use in patients with breast cancer, according to an announcement from Lumicell, Inc.
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GEN-002 Plus Avelumab Shows Promise as Third-line Option in PD-L1+ Gastric Cancer
May 22nd 2023The combination of GEN-002 and avelumab elicited responses in patients with advanced gastric or gastroesophageal junction adenocarcinoma, according to findings from an interim analysis of an ongoing phase 2 trial.
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FDA Approves Epcoritamab for Relapsed/Refractory DLBCL
May 19th 2023The FDA has approved the first T-cell–engaging bispecific antibody, epcoritamab-bysp (Epkinly), for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma, after 2 or more lines of systemic therapies.
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Chinese Phase 3 Trial of Roxadustat in Non-Myeloid Malignancies Meets Primary End Point
May 18th 2023Roxadustat proved to be noninferior to recombinant erythropoietin alfa with regard to change in hemoglobin level from baseline to an average level during weeks 9 to 13 in patients receiving concurrent chemotherapy for non-myeloid malignancies in China, meeting the primary end point of an ongoing phase 3 trial.
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Capivasertib plus fulvestrant provided a clinically meaningful improvement in progression-free survival over fulvestrant alone in patients with hormone receptor–positive advanced breast cancer, including those who previously received a CDK4/6 inhibitor, chemotherapy in the advanced setting, or had baseline liver metastases.
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