FDA Approves Osimertinib as Adjuvant Therapy for NSCLC with EGFR Exon 19 Deletions or Exon 21 L858R Mutations
Efficacy was demonstrated in ADAURA study
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FDA Approves Margetuximab for Metastatic HER2-positive Breast Cancer
Evidence for efficacy was evaluated in SOPHIA study
EMA Recommends Granting a Marketing Authorisation for Fedratinib
JAK inhibitor is intended for the treatment of primary myelofibrosis and of myelofibrosis secondary to polycythaemia vera or essential thrombocythaemia
EMA Recommends Granting a Marketing Authorisation for Tucatinib
It is intended for the treatment of HER2-positive locally advanced or metastatic breast cancer
EMA Recommends Granting a Marketing Authorisation Under Exceptional Circumstances for Moxetumomab Pasudotox
It is intended for the treatment of relapsed or refractory hairy cell leukaemia
EMA Recommends Granting a Marketing Authorisation for Generic Sunitinib
Sunitinib Accord is a generic of Sutent, which has been authorised in the EU since 2006
EMA Recommends Extension of Indications for Avelumab
New indication concerns the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma
EMA Recommends Granting a Conditional Marketing Authorisation for Selpercatinib
It is intended for the treatment of RET-fusion positive NSCLC, RET-fusion positive thyroid cancer and RET-mutant medullary-thyroid cancer
EMA Recommends Granting a Conditional Marketing Authorisation for Trastuzumab Deruxtecan
It is intended for the treatment of metastatic HER2-positive breast cancer
EMA Recommends Extension of Indications for Pembrolizumab
New indication concerns the first-line treatment of metastatic MSI-H or dMMR colorectal cancer
Intratumoural and Intracavitary Administration of Ipilimumab Plus Nivolumab Is Feasible and Safe in Recurrent Glioblastoma
Patients received intratumoural administration of ipilimumab plus nivolumab that was followed by intracavitary nivolumab plus nivolumab given intravenously
TG4001 Therapeutic Vaccination Plus Avelumab-Mediated PD-L1 Blockade Improves Tumour Microenvironment in HPV-Positive Malignancies
This combination changes “cold” tumour microenvironments to “hot” in Human Papillomavirus-positive malignancies