EMA Recommends Granting Marketing Authorisation for Azacitidine Accord
It is a generic of Vidaza, which has been authorised in the EU since December 2008
Oncology News
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1551 results
FDA Approves Avapritinib for GIST with a PDGFRA Exon 18 Mutation
Efficacy was evaluated in NAVIGATOR trial
EMA Recommends Extension of Therapeutic Indications for Daratumumab
New indication concerns combination treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant
FDA Approves Pembrolizumab for BCG-Unresponsive, High-Risk Non-Muscle Invasive Bladder Cancer
Efficacy was evaluated in KEYNOTE-057 trial
Oligometastatic Disease Classification
Consensus recommendations from the EORTC and ESTRO’s Cancer OligoCare project
FDA Approves Olaparib for Germline BRCA-mutated Metastatic Pancreatic Adenocarcinoma
It also approved the BRACAnalysis CDx test as a companion diagnostic
FDA Approves Enzalutamide for Metastatic Castration-Sensitive Prostate Cancer
Evidence for efficacy was evaluated in the ARCHES trial
FDA Grants Accelerated Approval to Enfortumab Vedotin-ejfv for Metastatic Urothelial Cancer
It is the first Nectin-4-directed antibody-drug conjugate to receive FDA approval
FDA Approves Fam-Trastuzumab Deruxtecan-nxki for Unresectable or Metastatic HER2-positive Breast Cancer
Efficacy was evaluated in the DESTINY-Breast01 trial
EMA Recommends Extension of Therapeutic Indications for Ramucirumab
New indication concerns combination with erlotinib for the first-line treatment of adult patients with metastatic NSCLC with activating EGFR mutations
EMA Recommends a Change to the Terms of the Marketing Authorisation for Akynzeo
Positive opinion is related to a new pharmaceutical form associated with a new strength and a new route of administration
Asciminib Shows Activity in Heavily Pretreated Patients with CML
It binds to the myristoyl pocket, a previously unexploited feature of ABL1 and ABL2 kinases