EMA Publishes Guidance to Provide Key Methods and Good Regulatory Practices on the Planning and Conduct of Registry-Based Studies
Generating high-quality evidence from registry-based studies
Oncology News
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FDA Approves Asciminib for Philadelphia Chromosome-Positive Chronic Myeloid Leukaemia
Evidence for efficacy is based on the results from the ASCEMBL and CABL001X2101 studies
EMA Recommends Granting a Conditional Marketing Authorisation for Amivantamab
It is indicated for treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations, after failure of platinum-based therapy
Long-Term Outcomes in Patients with Metastatic Melanoma Treated with Anti-PD1 Therapy Based on PET Response
PET may have utility in predicting long term benefit and help guide discontinuation of therapy
Germline Pathogenic Variants in CDH1, BRCA2, CHEK2, ATM, and PALB2 Associated with Increased Risk of Invasive Lobular Carcinoma
Multigene panel testing may be appropriate for women with invasive lobular carcinoma and to identify women at risk
Cure Probability Models for Evaluation of Patients with a Previous Cancer Diagnosis for Solid Organ Transplantation
Evaluation and referral of patients with cancer based on cure probability could increase safety and overall population-level benefit of transplantation
EMA Recommends Granting a Marketing Authorisation for Sacituzumab Govitecan
It is indicated for the treatment of adult patients with unresectable or metastatic TNBC who have received two or more prior systemic therapies
FDA Approves Atezolizumab as Adjuvant Treatment for Non-Small Cell Lung Cancer
Evidence for efficacy is based on the results from the IMpower010 study
EMA Recommends Granting a Marketing Authorisation for Zanubrutinib for the Treatment of Waldenström’s Macroglobulinaemia
It is indicated in patients who have received at least one prior therapy, or in first-line treatment for patients unsuitable for chemo-immunotherapy
Nivolumab Plus Low-Dose Ipilimumab Demonstrates Clinical Benefit in First-Line Treatment for MSI-H/dMMR mCRC
Findings from the CheckMate 142 study in patients with microsatellite instability-high/mismatch repair-deficient metastatic colorectal cancer
Adjuvant Abemaciclib Combined with Endocrine Therapy Improves IDFS in HR-Positive, HER2−Negative, Node-Positive, High-Risk, Early Breast Cancer
Updated results from the monarchE study point to abemaciclib benefit regardless of Ki-67 status
Zilovertamab Vedotin Is Safe and Demonstrates Activity In Heavily Pretreated Patients With Lymphoid Malignancies
Findings from a phase I study of selective ROR1 targeting