WHO Outlines New Framework for Early Detection and Management of Breast Cancer
February 3rd 2023The World Health Organization has released new framework guidelines with the goal of saving 2.5 million lives from breast cancer by 2040 through a combination of early detection, timely diagnosis, and comprehensive management.
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FDA Approves Sacituzumab Govitecan for Pretreated HR+/HER2– Metastatic Breast Cancer
February 3rd 2023The FDA has approved sacituzumab govitecan-hziy (Trodelvy) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor–positive, HER2-negative breast cancer who have received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting.
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The combination of pembrolizumab plus carboplatin and paclitaxel demonstrated a statistically significant and clinically meaningful improvement in progression-free survival vs chemotherapy alone in the first-line treatment of patients with stage III/IV or recurrent endometrial cancer.
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FDA Approves Elacestrant for ER+/HER2–, ESR1-Mutated Advanced or Metastatic Breast Cancer
January 27th 2023The FDA has approved elacestrant (Orserdu) for the treatment of postmenopausal women or adult men with estrogen receptor–positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least 1 line of endocrine therapy.
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Cilta-cel Meets PFS End Point in Relapsed/Lenalidomide-Refractory Multiple Myeloma
January 27th 2023Ciltacabtagene autoleucel demonstrated a significant improvement in progression-free survival in patients with relapsed/lenalidomide-refractory multiple myeloma who received 1 to 3 prior lines of therapy.
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Phase 1/2 Trial Pauses Enrollment for Evaluation of MGTA-117 in AML/MDS After Patient Death
January 26th 2023Magenta Therapeutics has voluntarily paused enrollment for a phase 1/2 trial evaluating the antibody-drug conjugate MGTA-117 in patients with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome following the death of a patient.
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Avutometinib Plus Defactinib Generates Responses in Recurrent Low-Grade Serous Ovarian Cancer
January 25th 2023The combination of avutometinib and defactinib elicited responses in patients with recurrent low-grade serious ovarian cancer, according to data from a planned interim analysis of the registration-directed phase 2 RAMP-201 trial.
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KEYNOTE-991 Trial of Pembrolizumab Plus Enzalutamide/ADT in mHSPC to Stop for Futility
January 25th 2023Merck is discontinuing the phase 3 KEYNOTE-991 trial evaluating pembrolizumab plus enzalutamide and androgen deprivation therapy vs placebo plus enzalutamide/ADT in patients with metastatic hormone-sensitive prostate cancer due to futility.
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Ripretinib Demonstrates Clinical Benefit in KIT Exon 11, 17/18–Mutated Advanced GIST
January 24th 2023Second-line ripretinib produced a clinical benefit in patients with advanced gastrointestinal stromal tumor harboring KIT exon 11 and 17/18 mutations who progressed on or were intolerant to imatinib.
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FDA Receives Premarket Approval Application for Noninvasive CRC Screening Test
January 24th 2023Geneoscopy has submitted a premarket approval application to the FDA for a noninvasive, stool-based, at-home screening test to detect colorectal cancer and advanced adenomas in average-risk individuals.
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First-line treatment with the combination of liposomal irinotecan plus 5-fluorouracil, leucovorin, and oxaliplatin produced a clinically meaningful and statistically significant improvement in overall survival and progression-free survival vs nab-paclitaxel plus gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma, according to results from the phase 3 NAPOLI 3 trial.
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FDA Approves Tucatinib Plus Trastuzumab for RAS Wild-type, HER2+ Metastatic Colorectal Cancer
January 19th 2023The FDA has granted accelerated approval to tucatinib in combination with trastuzumab for adult patients with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed after treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
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UK’s MHRA Approves Zanubrutinib for CLL and MZL
January 19th 2023The Medicines and Healthcare Products Regulatory Agency has approved zanubrutinib in Great Britain for both the treatment of adult patients with chronic lymphocytic leukemia and the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20–based therapy.
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Adjuvant Atezolizumab/Bevacizumab Combo Meets RFS End Point in Early-Stage HCC
January 19th 2023Adjuvant treatment with the combination of atezolizumab and bevacizumab demonstrated a statistically significant improvement in recurrence-free survival compared with active surveillance in patients with early-stage hepatocellular carcinoma at high risk of disease recurrence.
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Perioperative Toripalimab Plus Chemotherapy Meets EFS End Point in NSCLC
January 18th 2023Perioperative treatment with the combination of toripalimab plus platinum-containing doublet chemotherapy, followed by toripalimab monotherapy as consolidation therapy after surgery, significantly extended event-free survival compared with chemotherapy plus placebo in patients with operable NSCLC.
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TP-3654 Showcases Early Signs of Tolerability, Clinical Activity in Myelofibrosis
January 17th 2023The PIM1 kinase inhibitor TP-3654 was well tolerated and showcased preliminary signs of activity, including spleen volume reduction, symptom improvement, and broad cytokine reduction, in patients with myelofibrosis who were previously treated with or were ineligible for a JAK inhibitor.
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BXCL701 Plus Pembrolizumab Generates Promising Responses in Small Cell Neuroendocrine mCRPC
January 11th 2023The combination of BXCL701 and pembrolizumab produced encouraging responses in patients with small cell neuroendocrine carcinoma metastatic castration-resistant prostate cancer, according to topline data from a phase 2 trial.
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FDA Grants Fast Track Designation to CFI-402257 for ER+/HER2– Breast Cancer
January 11th 2023The FDA has granted a fast track designation to best-in-class threonine tyrosine kinase inhibitor CFI-402257 for the treatment of adult patients with estrogen receptor (ER)–positive/HER2-negative advanced breast cancer after disease progression on prior CDK4/6 inhibitors and endocrine therapy.
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At-Home Screening Test Demonstrates Sensitivity, Specificity in Detecting CRC
January 10th 2023Geneoscopy’s at-home, stool-based diagnostic screening test to detect colorectal cancer and advanced adenomas in average-risk individuals displayed high sensitivity and specificity, meeting the primary objectives of the phase 3 CRC-PREVENT trial.
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IBI351 Gets Breakthrough Therapy Designation for KRAS G12C–Mutated NSCLC in China
January 10th 2023The Center for Drug Evaluation of China's National Medical Products Administration has granted a breakthrough therapy designation to IBI351 for the treatment of patients with advanced non–small cell lung cancer harboring a KRAS G12C mutation who have received at least 1 prior line of systemic therapy.
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