FDA Grants Clearance for Phase 3 Study of Lisaftoclax in Previously Treated CLL/SLL
August 7th 2023The FDA has granted clearance for a global, registrational, phase 3 study examining lisaftoclax in combination with a BTK inhibitor in patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who received prior treatment with a BTK inhibitor.
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Platinum Chemotherapy Shortages Create Additional Burden for Patients With Cancer
August 7th 2023Jacob Sands, MD, discusses how the ongoing shortages of carboplatin and cisplatin have presented new challenges to patient care, how he and colleagues at Dana-Farber Cancer Institute are navigating these shortages, and how these limitations could ultimately have an impact on patients.
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Sacituzumab Govitecan Wins Approval in Europe for Pretreated HR+/HER2– Metastatic Breast Cancer
July 28th 2023The European Commission has approved sacituzumab govitecan-hziy for the treatment of adult patients with unresectable or metastatic hormone receptor–positive, HER2-negative breast cancer who have received endocrine-based therapy and at least 2 additional systemic therapies in the advanced setting
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UGN-102 Improves Survival, Elicits CRs in Low-Grade, Intermediate-Risk NMIBC
July 27th 2023Treatment with UGN-102 with or without transurethral resection of bladder tumors led to an improvement in disease-free survival compared with TURBT alone in patients with low-grade, intermediate-risk non–muscle-invasive bladder cancer.
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Upifitamab Rilsodotin Fails to Meet ORR End Point in NaPi2b+ Platinum-Resistant Ovarian Cancer
July 27th 2023The phase 1/2 UPLIFT trial evaluating the antibody-drug conjugate upifitamab rilsodotin in patients with platinum-resistant ovarian cancer failed to meet its primary end point of investigator-assessed overall response rate in the NaPi2b-positive population.
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mRNA-4157 Plus Pembrolizumab Under Further Investigation in Phase 3 Trial in High-Risk Melanoma
July 26th 2023The combination of mRNA-4157 and pembrolizumab will be further evaluated as an adjuvant treatment option for patients with resected, high-risk, stage IIB to IV melanoma in the phase 3 V940-001 trial.
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NCCN Adds Flotufolastat F 18 Injection to Clinical Practice Guidelines for Prostate Cancer
July 26th 2023The National Comprehensive Cancer Network has added flotufolastat F 18 injection to its Clinical Practice Guidelines in Oncology for positron emission tomography of prostate-specific membrane antigen–positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy.
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First-Line Rivoceranib Plus Camrelizumab Improves Survival in Unresectable HCC
July 25th 2023Treatment with the combination of rivoceranib and camrelizumab led to a statistically significant and clinically meaningful benefit in progression-free survival and overall survival compared with sorafenib in previously untreated patients with unresectable hepatocellular carcinoma.
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Gilead Discontinues Phase 3 ENHANCE Trial of Magrolimab/Azacitidine in Higher-Risk MDS
July 25th 2023The phase 3 ENHANCE trial evaluating the first-line combination of magrolimab and azacitidine vs placebo plus azacitidine in patients with higher-risk myelodysplastic syndrome has been discontinued due to futility at a planned analysis.
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Axatilimab Meets ORR End Point in Chronic GVHD After 2 or More Prior Lines of Therapy
July 24th 2023The anti–CSF-R1 antibody axatilimab generated responses in adult and pediatric patients with chronic graft-vs-host disease who received 2 or more prior lines of therapy, meeting the primary end point in all cohorts of patients in the phase 2 AGAVE-201 trial.
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FDA Approves Companion Diagnostic for Quizartinib in FLT3-ITD+ AML
July 24th 2023The FDA has approved the LeukoStrat CDx FLT3 Mutation Assay for use as a companion diagnostic to select patients with FLT3-ITD–positive acute myeloid leukemia who may be eligible to receive treatment with quizartinib (Vanflyta).1
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Adjuvant Nivolumab Receives CHMP Recommendation for Completely Resected Stage IIB/C Melanoma
July 21st 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of nivolumab monotherapy for the adjuvant treatment of patients at least 12 years of age with completely resected stage IIB or IIC melanoma.
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Epcoritamab Approaches EU Approval for Relapsed/Refractory DLBCL
July 21st 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending conditional marketing authorization to epcoritamab monotherapy for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma after 2 or more lines of systemic therapy.
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FDA Approves Quizartinib Plus Chemotherapy for Newly Diagnosed, FLT3-ITD+ AML
July 20th 2023The FDA has approved quizartinib in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia that is FLT3-ITD positive, as detected by an FDA-approved test.
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APVO436 Plus Venetoclax/Azacitidine Produces Durable Remissions in Relapsed/Refractory AML
July 20th 2023Treatment with the CD3 x CD123 bispecific antibody APVO436 plus venetoclax and azacitidine led to durable remissions in patients with relapsed/refractory acute myeloid leukemia who had not received prior venetoclax.
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China’s NMPA Accepts sNDA for First-Line Toripalimab Plus Chemo in ES-SCLC
July 20th 2023China’s National Medical Products Administration has accepted a supplemental new drug application seeking the approval of toripalimab in combination with platinum-based chemotherapy for the first-line treatment of patients with extensive-stage small cell lung cancer.
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IMX-110 Plus Tislelizumab Leads to Tumor Shrinkage in Heavily Pretreated mCRC
July 19th 2023Treatment with the combination of the tissue-specific therapeutic IMX-110 and the anti–PD-1 antibody tislelizumab led to tumor shrinkage in heavily pretreated patients with metastatic colorectal cancer.
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Setanaxib Plus Pembrolizumab Elicits PFS Benefit in Recurrent or Metastatic HNSCC
July 18th 2023The combination of the NOX1/4 inhibitor setanaxib and pembrolizumab produced progression-free survival benefits compared with placebo plus pembrolizumab in patients with recurrent or metastatic head and neck squamous cell carcinoma.
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NOX-A12 Plus Radiotherapy and Bevacizumab Produces Responses in Previously Untreated Glioblastoma
July 17th 2023The addition of the CXCL12 inhibitor NOX-A12 to standard-of-care radiotherapy and bevacizumab elicited responses when used as first-line treatment in patients with glioblastoma, according to updated data from the expansion arm of the phase 1/2 GLORIA trial.
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EMA Accepts Marketing Application for Zolbetuximab in CLDN18.2+ Gastric/GEJ Adenocarcinoma
July 17th 2023The European Medicines Agency has accepted a marketing authorization application seeking the approval of zolbetuximab for first-line treatment of patients with Claudin18.2-positive, HER2-negative, unresectable, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
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FDA Accepts NDA for Rivoceranib Plus Camrelizumab in Unresectable HCC
July 17th 2023The FDA has accepted for review a new drug application seeking the approval of rivoceranib in combination with camrelizumab as a first-line treatment option for patients with unresectable hepatocellular carcinoma.
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