Withdrawal of Application to Change the EU Marketing Authorisation for Cervarix
Withdrawal concerns application to use Cervarix in individuals from the age of 9 years for the prevention of head and neck cancers
Oncology News
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1533 results
Dalpiciclib plus Fulvestrant in Pretreated HR-positive, HER2-negative Advanced Breast Cancer
The results from a randomised, phase III DAWNA-1 study with a new, orally administered, selective CDK4/6 inhibitor
ctDNA-Guided Therapy with Pertuzumab plus Trastuzumab for HER2-Amplified mCRC
Results from the first prospective study showing that patients with HER2-amplified metastatic colorectal cancer identified by ctDNA genotyping benefit from dual-HER2 blockade similarly to patients identified by conventional tissue analysis
EMA Recommends Granting a Conditional Marketing Authorisation for Sotorasib
It is intended for the treatment of patients with advanced NSCLC with KRAS G12C mutation who have progressed after at least one prior line of systemic therapy
FDA Approves Pembrolizumab for Adjuvant Treatment of Renal Cell Carcinoma
Evidence for efficacy is based on the results from the KEYNOTE-564 study
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
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