A5044765549- Cancer Immunotherapy and Biomarkers
- Bladder and Urothelial Cancer Treatments
- Urinary and Genital Oncology Studies
- Gastrointestinal Tumor Research and Treatment
- PI3K/AKT/mTOR signaling in cancer
- Chronic Lymphocytic Leukemia Research
- Gastric Cancer Management and Outcomes
- Gastrointestinal disorders and treatments
- Lung Cancer Treatments and Mutations
- Pancreatic and Hepatic Oncology Research
- Vascular Malformations and Hemangiomas
- Lung Cancer Diagnosis and Treatment
- Neuroblastoma Research and Treatments
- Adenosine and Purinergic Signaling
- Glioma Diagnosis and Treatment
- Pleural and Pulmonary Diseases
- Occupational and environmental lung diseases
- Cholangiocarcinoma and Gallbladder Cancer Studies
- Brain Metastases and Treatment
- Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis
- Hepatocellular Carcinoma Treatment and Prognosis
United States Food and Drug Administration
2021-2024
Center for Drug Evaluation and Research
2021-2023
Center for Devices and Radiological Health
2023
Abstract On March 16, 2023, the FDA approved dabrafenib in combination with trametinib (Tafinlar, Mekinist; Novartis Pharmaceuticals Corporation) for treatment of pediatric patients low-grade glioma (LGG) a BRAFV600E mutation who require systemic therapy. also oral formulations both drugs suitable cannot swallow pills. This approval was based on LGG cohort from study CDRB436G2201 (NCT02684058), multicenter, open-label trial which were randomly assigned 2:1 to plus (D+T) or carboplatin...
On October 21, 2022, the FDA approved tremelimumab (Imjudo) in combination with durvalumab for adult patients unresectable hepatocellular carcinoma. The approval was based on results from HIMALAYA study, which carcinoma who were naïve to previous systemic treatment randomly assigned receive one of three study arms: (n = 393), 389), or sorafenib 389). primary objective improvement overall survival (OS) compared met statistical significance a stratified HR 0.78 [95% confidence interval (CI),...
Abstract The FDA granted accelerated approval for amivantamab-vmjw (hereafter referred to as amivantamab), a bispecific antibody directed against EGFR and mesenchymal–epithelial transition receptor, on May 21, 2021, the treatment of adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) exon 20 insertion mutations whose disease has progressed after platinum-based chemotherapy. Approval was based results an ongoing, multicenter, nonrandomized, open-label,...
On October 2, 2020, FDA approved nivolumab with ipilimumab as first-line treatment for adult patients unresectable malignant pleural mesothelioma (MPM). The approval was based on results from Study CA209743 (CHECKMATE-743), an open-label trial of MPM randomized to receive and up 2 years (
Abstract On April 5, 2022, FDA granted accelerated approval to alpelisib for the treatment of adult and pediatric patients 2 years age older with severe manifestations PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy. Efficacy was evaluated using real-world data (RWD) from EPIK-P1 (NCT04285723), a single-arm clinical study in or life-threatening PROS received as part an expanded access program (EAP) compassionate use. The primary endpoint confirmed radiologic response...
Abstract On December 15, 2023, the FDA granted traditional approval to enfortumab vedotin-ejfv plus pembrolizumab (EV + Pembro) for patients with locally advanced or metastatic urothelial carcinoma (la/mUC). Substantial evidence of effectiveness was obtained from EV-302/KEYNOTE-A39 (NCT04223856), an open-label, randomized trial evaluating EV Pembro versus cisplatin carboplatin gemcitabine (Plat Gem) in previously untreated la/mUC. A total 886 were (1:1) receive 1.25 mg/kg intravenously on...
Abstract On September 30, 2022, the FDA granted accelerated approval to futibatinib for treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) FGFR2 fusions other rearrangements. Approval was based on Study TAS-120–101, a multicenter open-label, single-arm trial. Patients received 20-mg orally once daily. The major efficacy outcome measures were overall response rate (ORR) and duration (DoR) as determined by an...
<div>Abstract<p>On April 5, 2022, FDA granted accelerated approval to alpelisib for the treatment of adult and pediatric patients 2 years age older with severe manifestations PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy. Efficacy was evaluated using real-world data (RWD) from EPIK-P1 (NCT04285723), a single-arm clinical study in or life-threatening PROS received as part an expanded access program (EAP) compassionate use. The primary endpoint confirmed...
On May 15, 2020, the FDA approved ripretinib for adult patients with advanced gastrointestinal stromal tumor who have received prior treatment three or more kinase inhibitors, including imatinib. The approval was based on results from INVICTUS (NCT03353753), an international, multi-center, double-blind, placebo-controlled trial. Patients were randomly allocated (2:1) to receive either 150 mg once daily (n = 85) matching placebo 44). trial demonstrated a statistically significant improvement...
<div>Abstract<p>On April 5, 2022, FDA granted accelerated approval to alpelisib for the treatment of adult and pediatric patients 2 years age older with severe manifestations PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy. Efficacy was evaluated using real-world data (RWD) from EPIK-P1 (NCT04285723), a single-arm clinical study in or life-threatening PROS received as part an expanded access program (EAP) compassionate use. The primary endpoint confirmed...
<p>Kaplan-Meier curves of overall survival in EV-302</p>
<div>Abstract<p>On December 15, 2023, the FDA granted traditional approval to enfortumab vedotin-ejfv plus pembrolizumab (EV + Pembro) for patients with locally advanced or metastatic urothelial carcinoma (la/mUC). Substantial evidence of effectiveness was obtained from EV-302/KEYNOTE-A39 (NCT04223856), an open-label, randomized trial evaluating EV Pembro versus cisplatin carboplatin gemcitabine (Plat Gem) in previously untreated la/mUC. A total 886 were (1:1) receive 1.25 mg/kg...
<p>Kaplan-Meier curves of BICR-assessed progression-free survival in EV-302</p>
<div>Abstract<p>On May 15, 2020, the FDA approved ripretinib for adult patients with advanced gastrointestinal stromal tumor who have received prior treatment three or more kinase inhibitors, including imatinib. The approval was based on results from INVICTUS (NCT03353753), an international, multi-center, double-blind, placebo-controlled trial. Patients were randomly allocated (2:1) to receive either 150 mg once daily (<i>n</i> = 85) matching placebo 44). trial...
<div>Abstract<p>On May 15, 2020, the FDA approved ripretinib for adult patients with advanced gastrointestinal stromal tumor who have received prior treatment three or more kinase inhibitors, including imatinib. The approval was based on results from INVICTUS (NCT03353753), an international, multi-center, double-blind, placebo-controlled trial. Patients were randomly allocated (2:1) to receive either 150 mg once daily (<i>n</i> = 85) matching placebo 44). trial...