EMA Recommends Granting a Marketing Authorisation for Lazertinib
It is indicated in combination with amivantamab for the first-line treatment of patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations
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FDA Approves Obecabtagene Autoleucel for Adults with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukaemia
Evidence for efficacy is based on the results from the FELIX study
Adding Pembrolizumab To Preoperative Radiotherapy and Surgery Improves DFS for Patients with Stage III Soft Tissue Sarcomas of the Extremity
Findings from the SU2C-SARC032 study
Contact X-ray Brachytherapy Dose Escalation Increases the Organ Preservation Rate in Patients with Small, Early-Stage Rectal Cancer
Findings from the OPERA study
Inavolisib Plus Palbociclib–Fulvestrant Prolongs PFS in Patients with PIK3CA-mutated, HR-positive, HER2-negative Advanced Breast Cancer
Findings from the INAVO120 study
EMA Recommends Granting a Conditional Marketing Authorisation for Repotrectinib
It is intended for the treatment of patients with solid tumours with NTRK gene fusion and patients with ROS1-positive advanced NSCLC
FDA Grants Accelerated Approval to Asciminib for Newly Diagnosed Chronic Myeloid Leukaemia
Evidence for efficacy is based on the results from the ASC4FIRST study
Adding Pembrolizumab to Chemotherapy Results in Improved PFS and OS in Patients with Advanced and Recurrent Cervical Cancer Regardless of Bevacizumab Use
Findings from the subgroup analysis of the KEYNOTE-826 study
Neoadjuvant Nivolumab/Relatlimab Induces High Rates of Pathologic Responses in Patients with Locally Advanced MMR-deficient Colon Cancer
Findings from the NICHE-3 study
Neoadjuvant ICI Without Chemotherapy Demonstrates Potential Efficacy in Patients with Early-Stage TNBC
Findings from the BELLINI study
FDA Approves Inavolisib with Palbociclib and Fulvestrant for Endocrine-Resistant, PIK3CA-mutated, HR-positive, HER2-negative Advanced Breast Cancer
Evidence for efficacy is based on the results from the INAVO120 study
EMA Recommends Extension of Indications for Tislelizumab to First-Line Treatment of Gastric or GEJ Adenocarcinoma and Oesophageal Squamous Cell Carcinoma
New indications concern patients with previously untreated gastric or gastro-oesophageal junction adenocarcinoma and oesophageal squamous cell carcinoma