Enfortumab Vedotin Plus Pembrolizumab Has Potential to Alter SOC in Frontline Urothelial Cancer
November 10th 2023The combination of enfortumab vedotin-ejfv plus pembrolizumab represents a chemotherapy-free regimen that could alter the standard of care in the frontline treatment of all patients with metastatic urothelial carcinoma.
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Data Continue to Refine Frontline BTK Inhibitor Selection in CLL
November 8th 2023Along with the combination of venetoclax and obinutuzumab, the BTK inhibitor–based regimens of zanubrutinib monotherapy and acalabrutinib plus obinutuzumab represent the preferred options in the National Comprehensive Cancer Network Guidelines for the first-line treatment of patients with chronic lymphocytic leukemia without 17p deletions or TP53 mutations.
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Frontline Cadonilimab Plus Chemotherapy Improves OS in Advanced Gastric/GEJ Adenocarcinoma
November 7th 2023First-line treatment with the PD-1/CTLA-4 bispecific antibody cadonilimab in combination with oxaliplatin and capecitabine led to a statistically significant improvement in overall survival vs placebo plus oxaliplatin and capecitabine in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, meeting the primary end point of the phase 3 AK104-302 trial.
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FDA Accepts IND for Novel CDH17-Targeted CAR T-Cell Therapy for Advanced Gastrointestinal Cancers
November 6th 2023The FDA has cleared the investigational new drug application for CHM 2101, a novel CDH17-targeted CAR T-cell therapy, for the treatment of patients with gastrointestinal cancers.
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EU Approval Sought for Encorafenib/Binimetinib in BRAF V600+ Advanced NSCLC
November 2nd 2023The European Medicines Agency had validated a marketing authorization application seeking the approval of the combination of encorafenib and binimetinib for the treatment of adult patients with BRAF V600–mutant advanced non–small cell lung cancer.
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Adjuvant Pembrolizumab Improves OS in Select Patients With RCC After Nephrectomy
November 1st 2023Adjuvant treatment with pembrolizumab significantly improved overall survival vs placebo in patients with renal cell carcinoma at intermediate-high or high risk of recurrence after nephrectomy, or after nephrectomy and resection of metastatic lesions, meeting a key secondary end point of the phase 3 KEYNOTE-564 trial.
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FDA Grants Priority Review to Tovorafenib in Pediatric Relapsed/Progressive Low-Grade Glioma
October 30th 2023The FDA has granted priority review to a new drug application seeking the approval of tovorafenib monotherapy for the treatment of pediatric patients with relapsed or progressive low-grade glioma.
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FDA Approves Toripalimab for Recurrent or Metastatic Nasopharyngeal Carcinoma
October 27th 2023The FDA has approved toripalimab-tpzi (Loqtorzi) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with metastatic or recurrent locally advanced nasopharyngeal carcinoma, and as monotherapy for the treatment of adult patients with recurrent, unresectable, or metastatic nasopharyngeal carcinoma with disease progression on or after platinum-containing chemotherapy.
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The European Medicines Agency has accepted a marketing authorization application seeking the approval of mirvetuximab soravtansine-gynx for the treatment of patients with folate receptor alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
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FDA Accepts BLA Resubmission for N-803 in BCG-Unresponsive, High-Risk NMIBC In Situ
October 26th 2023The FDA has accepted the resubmission of a biologics license application seeking the approval of N-803 in combination with Bacillus Calmette-Guérin for the treatment of patients with BCG-unresponsive, non–muscle-invasive bladder cancer with carcinoma in situ with or without Ta or T1 disease.
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Epcoritamab Receives UK Approval for R/R DLBCL After 2 Prior Lines of Therapy
October 24th 2023The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has granted conditional marketing authorization to epcoritamab-bysp monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic therapy.
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Trastuzumab Deruxtecan Wins EU Approval for HER2-Mutated Advanced NSCLC
October 23rd 2023The European Commission has approved fam-trastuzumab deruxtecan-nxki for the treatment of patients with advanced non–small cell lung cancer whose tumors harbor an activating HER2 mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.
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Zanubrutinib Receives NICE Recommendation for Treatment of CLL
October 20th 2023The United Kingdom’s National Institute for Health and Care Excellence has issued a final draft guidance recommending the approval of zanubrutinib for the treatment of adult patients with untreated, high-risk chronic lymphocytic leukemia harboring a 17p deletion or TP53 mutation.
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Subcutaneous Nivolumab Meets PK and ORR End Points in Pretreated Advanced or Metastatic ccRCC
October 19th 2023Treatment with subcutaneous nivolumab co-formulated with recombinant human hyaluronidase demonstrated noninferior pharmacokinetics vs intravenous nivolumab in patients with advanced or metastatic clear cell renal cell carcinoma who received prior systemic therapy.
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SLS009 Plus Venetoclax/Azacitidine Displays Activity, Tolerability in Relapsed/Refractory AML
October 17th 2023The addition of SLS009 to the combination of venetoclax and azacitidine produced anti-leukemic effects and was safe in patients with relapsed/refractory acute myeloid leukemia who did not respond or stopped responding to venetoclax-based therapies.
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Neoadjuvant Daromun Elicits RFS Benefit in Locally Advanced, Fully Resectable Melanoma
October 16th 2023Neoadjuvant treatment with intratumoral daromun led to a statistically significant and clinically meaningful improvement in recurrence-free survival compared with surgery alone in patients with locally advanced, fully resectable melanoma, meeting the primary end point of the phase 3 PIVOTAL trial.
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