Bemcentinib Plus SOC Is Well Tolerated, But Does Not Improve Efficacy in Metastatic Melanoma
November 20th 2023The addition of bemcentinib to the standard-of-care therapies of pembrolizumab or dabrafenib plus trametinib was well tolerated in patients with metastatic melanoma; however, it did not lead to improvements in overall response rate, progression-free survival, or overall survival vs SOC alone.
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FDA’s ODAC to Review Data for Ide-Cel in Triple-Class Exposed R/R Myeloma
November 20th 2023The FDA’s Oncologic Drugs Advisory Committee will meet to review data from the supplemental biologics license application seeking the approval of idecabtagene vicleucel for use in earlier lines of treatment for patients with triple-class exposed relapsed/refractory multiple myeloma.
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Interrupting combination treatment with axitinib and avelumab and switching to avelumab maintenance after a response at 36 weeks led to a decrease in treatment-related toxicities and delayed tumor progression in previously untreated patients with metastatic clear cell renal cell carcinoma.
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The FDA has approved capivasertib plus fulvestrant for the treatment of patients with HR-positive, HER2-negative, locally advanced or metastatic breast cancer harboring 1 or more PIK3CA, AKT1, or PTEN alterations, following progression on at least 1 endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
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The FDA has approved pembrolizumab in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic, HER2-negative gastric or gastroesophageal junction adenocarcinoma.
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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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