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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FDA Approves Companion Diagnostics for Encorafenib/Binimetinib in BRAF V600E+ Metastatic NSCLC
October 13th 2023The FDA has approved FoundationOne® CDx and FoundationOne Liquid CDx for use as companion diagnostics to identify patients with metastatic non–small cell lung cancer harboring BRAF V600E mutations who may benefit from treatment with the combination of encorafenib plus binimetinib.
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First-Line UV1 Vaccine Plus Pembrolizumab Sustains OS in Unresectable or Metastatic Melanoma
October 12th 2023First-line treatment with the universal cancer vaccine UV1 in combination with pembrolizumab sustained overall survival in patients with advanced unresectable or metastatic malignant melanoma, according to updated data from cohort 1 of the phase 1 UV1-103 trial.
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FDA Approves FoundationOne CDx Companion Diagnostic for Selpercatinib in RET+ Solid Tumors
October 10th 2023The FDA has approved FoundationOne CDx for use as a companion diagnostic for selpercatinib, which was approved by the FDA for the treatment of adult patients with locally advanced or metastatic solid tumors harboring a RET gene fusion whose disease has progressed on or following prior systemic treatment, or who have no satisfactory alternative treatment options.
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BXCL701 Plus Pembrolizumab Generates Positive OS Data in Small Cell Neuroendocrine mCRPC
October 10th 2023Treatment with the combination of the investigational oral innate immune activator BXCL701 and pembrolizumab led to a median overall survival of 13.6 months in patients with small cell neuroendocrine carcinoma metastatic castration-resistant prostate cancer.
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MRD Could Guide Venetoclax/Ibrutinib Duration in Previously Untreated, Intermediate-Risk CLL
October 8th 2023The duration of treatment with the combination of venetoclax and ibrutinib could be guided by both toxicities and minimal residual disease kinetics in previously untreated patients with intermediate-risk chronic lymphocytic leukemia, according to interim results from the phase 2 ERADIC trial.
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FDA Places Partial Clinical Hold on IND for Lacutamab in CTCL/PTCL
October 7th 2023The FDA has placed a partial clinical hold on investigational new drug application for lacutamab, leading to a pause in new patient enrollment for the phase 2 TELLOMAK trial and a phase 1b trial, which are evaluating the agent in patients with advanced cutaneous T-cell lymphoma and peripheral T-cell lymphoma, respectively.
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