A5064298075- Lung Cancer Treatments and Mutations
- Cancer Immunotherapy and Biomarkers
- Lung Cancer Research Studies
- Cancer Genomics and Diagnostics
- Lung Cancer Diagnosis and Treatment
- Pancreatic and Hepatic Oncology Research
- Gastric Cancer Management and Outcomes
- Colorectal Cancer Treatments and Studies
- Advanced Breast Cancer Therapies
- Head and Neck Cancer Studies
- Economic and Financial Impacts of Cancer
- Health Systems, Economic Evaluations, Quality of Life
- Pneumocystis jirovecii pneumonia detection and treatment
- Chronic Lymphocytic Leukemia Research
- Brain Metastases and Treatment
- Occupational and environmental lung diseases
- Statistical Methods in Clinical Trials
- Cancer Treatment and Pharmacology
- Colorectal and Anal Carcinomas
- Neurofibromatosis and Schwannoma Cases
- Pleural and Pulmonary Diseases
- HER2/EGFR in Cancer Research
- Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis
- Thyroid Cancer Diagnosis and Treatment
- Peptidase Inhibition and Analysis
United States Food and Drug Administration
2015-2024
Center for Drug Evaluation and Research
2015-2024
Office of Science
2023
National Cancer Institute
2010-2015
Center for Cancer Research
2015
Abstract On August 5, 2016, the U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA injection, Merck Sharp & Dohme Corp., Kenilworth, NJ) for treatment of patients with recurrent or metastatic head neck squamous cell carcinoma (HNSCC) disease progression on after platinum-containing chemotherapy. Approval was based objective response rate (ORR) duration (DoR) in a cohort nonrandomized multi-cohort trial (KEYNOTE-012) that included 174 HNSCC who had...
On June 22, 2017, the Food and Drug Administration expanded indications for dabrafenib trametinib to include treatment of patients with metastatic non-small cell lung cancer (NSCLC) harboring BRAF V600E mutations. Approval was based on results from an international, multicenter, multicohort, noncomparative, open-label trial, study BRF113928, which sequentially enrolled 93 who had received previous systemic advanced NSCLC (Cohort B, n = 57) or were treatment-naïve C, 36). All 150 mg orally...
On May 8, 2020, the FDA granted accelerated approval to selpercatinib for (i) adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC), (ii) and pediatric ≥12 years of age advanced or RET-mutant medullary thyroid who require systemic therapy, (iii) therapy are radioactive iodine refractory (if is appropriate). Approval was on basis clinically important effects overall response rate (ORR) prolonged duration responses observed in a multicenter, open-label,...
Abstract On December 11, 2015, the FDA granted accelerated approval to alectinib (Alecensa; Genentech) for treatment of patients with anaplastic lymphoma receptor tyrosine kinase (ALK)-positive, metastatic non–small cell lung cancer (NSCLC) who have progressed on or are intolerant crizotinib. This was based two single-arm trials including 225 treated 600 mg orally twice daily. The objective response rates (ORR) by an independent review committee in these studies were 38% [95% confidence...
Abstract The FDA granted accelerated approval for pralsetinib on September 4, 2020 non–small cell lung cancer (NSCLC) and December 1, thyroid cancer, for: (i) adult patients with metastatic RET fusion–positive NSCLC, (ii) pediatric ≥12 years of age advanced or RET-mutant medullary who require systemic therapy, (iii) therapy are radioactive iodine refractory (if is appropriate). Approval was based the results a multicenter, open-label, multi-cohort clinical trial (ARROW, NCT03037385),...
9000 Background: FDA-approved 1L treatment options for patients with PD-L1-high advanced NSCLC (PD-L1 score ≥50%) include IO ± chemo (± anti-angiogenics) but it is unclear if substantially improves efficacy outcomes when added to in this patient population. Methods: Data was pooled from 12 randomized controlled trials that investigated anti-PD-(L)1 regimens the of NSCLC. PD-L1 defined as proportion tumor cells stained by assay and analysis conducted ≥50%. OS, PFS, ORR were compared between...
Abstract FDA's approval of cemiplimab-rwlc on February 22, 2021, follows prior approvals pembrolizumab and atezolizumab for similar indications as first-line treatment patients with programmed death ligand-1 (PD-L1)–high advanced non–small cell lung cancer (NSCLC). Approvals these anti–PD-L1 agents were supported by statistically significant clinically meaningful improvements in overall survival (OS) international, multicenter, active-controlled randomized trials. In KEYNOTE-024, the OS HR...
9001 Background: While existing data suggest a detriment of immune checkpoint inhibitors (ICI) in other targetable mutations non-small cell lung cancer (NSCLC), limited retrospective analyses patients with Kirsten rat sarcoma oncogene ( KRAS)-mutated NSCLC benefit from ICI the front-line (1L). To better define this benefit, pooled 12 registrational clinical trials investigating 1L or without chemotherapy (chemo) documented KRAS status (mutant wildtype) was evaluated for efficacy ICI+chemo,...
On September 21, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selpercatinib (Retevmo®, Eli Lilly Company) for treatment of adult patients with locally advanced or metastatic solid tumors a rearranged during transfection (RET) gene fusion that have progressed on following prior systemic who no satisfactory alternative options. The was based data from Study LOXO-RET-17001 (LIBRETTO-001; NCT03157128), an international, non-randomized, multi-cohort clinical...
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 March 4, 2022, the US Food and Drug Administration (FDA) approved nivolumab plus platinum-doublet chemotherapy for neoadjuvant treatment of patients with resectable non-small-cell lung cancer (NSCLC). We discuss FDA's review key data regulatory considerations supporting this approval.
9001 Background: IO + chemotherapy ± anti-angiogenics comprise FDA-approved 1L regimens for metastatic NSCLC, with IO-only therapy approved only PD-L1-positive NSCLC. Patients PD-L1 scores 1-49% have many therapeutic options, and little is known about how subgroups of patients experience benefit across treatment regimens. Methods: Data was pooled from 8 randomized controlled trials investigating anti-PD-(L)1 as or in chemo-IO the advanced score defined proportion tumor cells stained by...
Abstract On October 15, 2021, the FDA approved atezolizumab as adjuvant therapy in patients with stage II to IIIA non–small cell lung cancer (NSCLC) whose tumors have programmed death ligand 1 (PD-L1) expression on ≥1% of tumor cells (TC), detected by an FDA-approved test. The approval was based results from IMpower010 trial, which 1,005 NSCLC who had completed resection and cisplatin-based chemotherapy were randomly assigned 1:1 receive for 16 cycles or best supportive care. primary...
Abstract Background Programmed death ligand 1 (PD-L1) expression is recognized as a key biomarker in the treatment of non–small cell lung cancer (NSCLC) with anti-PD(L)1 inhibitors. Previous work has highlighted that outcomes patients NSCLC treated inhibitors generally improve increasing PD-L1 expression. The objectives these analyses are to quantitate effect on outcomes, characterize potentially nonlinear relationship between and assess potential differences relationships across subgroups....
Abstract On March 30, 2017, the U.S. Food and Drug Administration (FDA) approved osimertinib for treatment of patients with metastatic, epidermal growth factor receptor (EGFR) T790M mutation-positive, non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed following EGFR tyrosine kinase inhibitor (TKI) therapy. Approval was based on demonstration a statistically significant difference in primary endpoint progression-free survival (PFS) when...
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 (
On December 12, 2014, the U.S. Food and Drug Administration (FDA) approved ramucirumab for use in combination with docetaxel treatment of patients metastatic non-small cell lung cancer (NSCLC) disease progression on or after platinum-based chemotherapy. Patients epidermal growth factor receptor anaplastic lymphoma kinase genomic tumor aberrations should have FDA-approved therapy these prior to receiving ramucirumab. This approval was based an improvement overall survival (OS) acceptable...
Clinical trial sponsors rely on eligibility criteria to control the characteristics of patients in their studies, promote safety participants, and optimize interpretation results. However, recent years, complex often overly restrictive inclusion exclusion have created substantial barriers patient access novel therapies, hindered recruitment completion, limited generalizability A LUNGevity Foundation working group developed a framework for lung cancer clinical criteria. The goals this are (1)...
Clinical trials have demonstrated the benefit of PD-1/PD-L1 blocking antibodies for treatment patients with advanced non-small cell lung cancer (NSCLC) in defined patient populations that often exclude moderate or severe hepatic renal impairment. We assessed association between overall survival (OS) and baseline organ function NSCLC treated real-world data (RWD; patient-level from electronic health records) pooled clinical trial submitted to US Food Drug Administration (FDA). The...