EMA Recommends Granting a Conditional Marketing Authorisation for Loncastuximab Tesirine
It is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma
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EMA Recommends Extension of Indications for Axicabtagene Ciloleucel
New indication concerns the treatment of patients with diffuse large cell lymphoma and high-grade B-cell lymphoma
RNF43 Mutations Warrant Further Validation for Potential to Prioritise Anti-EGFR/BRAF Combinations in Selected Patients with BRAFV600E-Mutated mCRC
Findings from an assessment of predictive value of RNF43 status in patients with BRAFV600E-mutated metastatic colorectal cancer
EMA Recommends Extension of Indications for Zanubrutinib
New indication concerns treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20-based therapy
Phase II LCMC3 Study of Neoadjuvant Atezolizumab Met Primary Endpoint with a Major Pathological Response Rate of 20% in Resectable Stage IB–IIIB NSCLC
Results of the largest study of preoperative immune checkpoint inhibitor monotherapy in patients with early-stage non-small cell lung cancer to date
FDA Approves Ibrutinib for Paediatric Patients with Chronic Graft Versus Host Disease, Including a New Oral Suspension
Evidence for efficacy is based on the results from the iMAGINE study
FDA Approves Durvalumab for Locally Advanced or Metastatic Biliary Tract Cancer
Evidence for efficacy is based on the results from the TOPAZ-1 study
FDA Approves Pemigatinib for Relapsed or Refractory Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement
Evidence for efficacy was evaluated in FIGHT-203 study
Utility of Serial ctDNA in Guiding Anti-EGFR Rechallenge in Metastatic Colorectal Cancer
Paired tissue and ctDNA sequencing identified multiple novel mutations, copy gains, and fusions that frequently co-occur as subclonal alterations
EMA Recommends Granting a Marketing Authorisation for Hybrid Thalidomide
Thalidomide Lipomed is intended for the treatment of multiple myeloma
Sacituzumab Govitecan Demonstrates Significant Improvement in Survival in Heavily Pretreated, Locally Recurrent Inoperable, or Metastatic HR-positive, HER2-negative Breast Cancer
Primary results of the TROPiCS-02 study
FDA Grants Accelerated Approval to fam-Trastuzumab Deruxtecan-nxki for HER2-Mutated NSCLC
FDA also approved companion diagnostics for selection of patients