Induction therapy with durvalumab plus chemotherapy and bevacizumab, followed by maintenance with olaparib plus durvalumab and bevacizumab, elicited a statistically significant and clinically meaningful improvement in progression-free survival compared with chemotherapy plus bevacizumab in patients with newly diagnosed advanced high-grade epithelial ovarian cancer who did not harbor BRCA mutations.
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Atezolizumab Following Neoadjuvant Atezolizumab and Resection Improves DFS in NSCLC
April 4th 2023Data for adjuvant atezolizumab following neoadjuvant atezolizumab and resection demonstrated an improvement in disease-free survival and a trend toward improved overall survival in patients with resectable stage IB to IIIB non–small cell lung cancer compared with those who did not receive adjuvant atezolizumab.
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TAVO-EP Plus Pembrolizumab Fails to Meet ORR End Point in Anti–PD-1–Refractory Advanced Melanoma
April 4th 2023The combination of the interleukin-12 encoding plasmid TAVO™-EP plus pembrolizumab did not meet the prespecified primary end point for overall response rate in patients with advanced melanoma that was refractory to anti–PD-1 therapy.
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The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of sodium thiosulfate injection for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to less than 18 years of age with localized, nonmetastatic solid tumors.
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Tusamitamab Ravtansine Plus Pembrolizumab With or Without Chemo Elicits Responses in CEACAM5+ NSCLC
April 1st 2023The combination of tusamitamab ravtansine and pembrolizumab with or without chemotherapy generated responses and was well tolerated when used as first-line treatment for patients with CEACAM5-positive nonsquamous non–small cell lung cancer.
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FDA Grants Fast Track Designation to PBP1510 in Metastatic Pancreatic Adenocarcinoma
March 31st 2023The FDA has granted a fast track designation to PBP1510 (ulenistamab) for the treatment of patients with unresectable or metastatic pancreatic adenocarcinoma that has relapsed following and/or is refractory to at least 1 prior line therapy.
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FDA Grants Fast Track Designation to RRx-001 for Severe Oral Mucositis in Head and Neck Cancer
March 30th 2023The FDA has granted a fast track designation to RRx-001 for the prevention and attenuation of severe oral mucositis associated with chemotherapy and radiation in patients with head and neck cancer.
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Up-front treatment with osimertinib reduced the risk of brain progression-free survival but provided a comparable overall survival benefit compared with sequential treatment with gefitinib followed by osimertinib in patients with advanced non–small cell lung cancer harboring EGFR mutations.
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Fixed-Duration Ibrutinib Plus Venetoclax Earns Approval in Canada for Previously Untreated CLL
March 28th 2023Canada Health has approved the fixed-duration, all-oral combination of ibrutinib and venetoclax for the frontline treatment of adult patients with chronic lymphocytic leukemia, including those with 17p deletion.
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Trastuzumab Deruxtecan Garners Approval in Japan for HER2-Low Metastatic Breast Cancer
March 27th 2023Japan’s Ministry of Health, Labor and Welfare has approved fam-trastuzumab deruxtecan-nxki for the treatment of adult patients with HER2-low unresectable or recurrent breast cancer after prior chemotherapy.
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FDA Approval Sought for Lifileucel in Unresectable or Metastatic Melanoma
March 27th 2023Iovance Biotherapeutics has submitted a rolling biologics license application to the FDA seeking the approval of the tumor infiltrating lymphocyte therapy lifileucel for the treatment of patients with advanced unresectable or metastatic melanoma who progressed on or after prior anti–PD-1/L1 therapy and targeted therapy.
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The addition of zolbetuximab to CAPOX led to a statistically significant improvement in progression-free survival and overall survival compared with placebo plus CAPOX for patients with Claudin-18.2–positive/HER2-negative, unresectable, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
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Second-line Axi-cel Elicits OS Benefit in Relapsed/Refractory LBCL
March 21st 2023Axicabtagene ciloleucel produced a statistically significant improvement in overall survival compared with standard-of-caretherapy in patients with relapsed/refractory large B-cell lymphoma, according to data from the ZUMA-7 trial.
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Vibostolimab/Pembrolizumab Coformulation Fails to Reach PFS End Point in Pretreated Metastatic NSCLC
March 17th 2023A coformulation of pembrolizumab and vibostolimab did not elicit a statistically significant improvement in progression-free survival vs docetaxel in pretreated patients with metastatic non–small cell lung cancer.
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NCCN Adds Ripretinib to Guidelines for Second-line Treatment of GIST
March 15th 2023Ripretinib has been added to the National Comprehensive Cancer Network Guidelines as a preferred regimen in the second-line treatment of patients with gastrointestinal stromal tumor who are intolerant to sunitinib.
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Vorasidenib Meets PFS End Point in IDH1/2-Mutant Low-Grade Glioma
March 14th 2023Vorasidenib monotherapy elicited a statistically significant and clinically meaningful improvement in progression-free survival compared with placebo in patients with residual or recurrent IDH1/2-mutant low-grade glioma.
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FDA Places Clinical Hold on Phase 1 Trial of XMT-2056 in HER2-expressing Solid Tumors
March 13th 2023The FDA has placed a clinical hold on a phase 1 trial investigating the antibody-drug conjugate XMT-2056 for the treatment of patients with advanced/recurrent solid tumors that express HER2.
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FDA Receives Type A Meeting Request for Synthetic Hypericin in Early-stage Cutaneous T-cell Lymphoma
March 13th 2023Soligenix has submitted a Type A meeting request to the FDA to discuss the contents of a refusal to file letter from the regulatory agency regarding the new drug application for synthetic hypericin for the treatment of early-stage cutaneous T-cell lymphoma.
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Pembrolizumab Plus Chemotherapy Meets OS End Point in Advanced Malignant Pleural Mesothelioma
March 10th 2023First-line treatment with the combination of pembrolizumab and chemotherapy generated a statistically significant and clinically meaningful improvement in overall survival compared with chemotherapy alone in patients with unresectable advanced or metastatic malignant pleural mesothelioma.
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