FDA Grants Accelerated Approval to Erdafitinib for Metastatic Urothelial Carcinoma
Approval of FGFR inhibitor is based on data from a cohort of patients enrolled on Study BLC2001
Oncology News
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1548 results
FDA Expands Pembrolizumab Indication for First-line Treatment of NSCLC (TPS ≥1%)
Approval is based on the results from KEYNOTE‑042 study
First-line Durvalumab Improves Survival Compared to Chemotherapy in Metastatic NSCLC
Two analyses from the MYSTIC study show improved survival supporting the use of front-line durvalumab over chemotherapy in metastatic NSCLC
Maintenance immunotherapy fails to improve survival in extensive small cell lung cancer
Maintenance immunotherapy fails to improve survival in extensive-stage small cell lung cancer (SCLC), according to late-breaking results from the CheckMate 451 study to be presented today at the European Lung Cancer Congress 2019.
PROs Were Consistent with the ITT Population Across PD-L1 Subgroups in Patients with Stage III NSCLC Receiving Durvalumab or Placebo
PD-L1 expression levels were generally not a factor in Quality of Life
Studies give new insights on immunotherapy in elderly patients with advanced NSCLC
Two studies to be reported at ELCC 2019 provide new insights on the efficacy and safety of immunotherapy in elderly patients with advanced non-small-cell lung cancer (NSCLC)
LOXO-195 Shows Promise in Tumours with Acquired Resistance to First-generation TRK-targeted Agents
Results from patients enrolled in a phase I study and FDA expanded access programme presented at AACR 2019
FDA Expands Approved Use of Palbociclib for Metastatic Breast Cancer
Extended indication concerns treatment of male patients
Global Microbial Signatures Specific for Colorectal Cancer Revealed
Results from meta analysis of foecal metagenomes
EMA Recommends Extension of Indications for Plerixafor
New indication concern combination with G-CSF to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours
EMA Recommends Extensions of Indication for Lenalidomide
Change in one of the existing indications concerns combination therapy in adult patients with previously untreated multiple myeloma who are not eligible for transplant
EMA Recommends Extension of Indications for Pomalidomide
New indication concerns treatment of adult patients with multiple myeloma in combination with bortezomib and dexamethasone after at least one prior regimen including lenalidomide