Global Oncology

Osimertinib received approval in China in combination with pemetrexed and platinum-based chemotherapy for patients with advanced EGFR-mutant NSCLC.

The Japanese PMDA has approved first-line osimertinib plus chemotherapy for EGFR-mutated advanced non–small cell lung cancer.

China’s NMPA approved toripalimab plus nab-paclitaxel for the first-line treatment of recurrent or metastatic triple-negative breast cancer.

The Ministry of Health, Labour, and Welfare in Japan has approved momelotinib for use in patients with myelofibrosis.

An expanded indication for dostarlimab plus chemotherapy for all adult patients with primary advanced or recurrent endometrial cancer is under EMA review.

Valemetostat tosilate has been approved by the Japan Ministry of Health, Labor and Welfare for the treatment of patients with relapsed/refractory PTCL.

The European Commission has approved fruquintinib for select patients with pretreated metastatic colorectal cancer.

The EMA has validated an extension application for the subcutaneous formulation of nivolumab in adult patients with solid tumor indications.

Tafasitamab plus lenalidomide has been granted priority review in China for transplant-ineligible, relapsed/refractory diffuse large B-cell lymphoma.

Capivasertib/fulvestrant was approved in the EU for pretreated, ER-positive, HER2‑negative advanced cancer with 1 or more PIK3CA, AKT1, or PTEN alterations.

Golidocitinib has received approval from China’s NMPA for relapsed/refractory peripheral T-cell lymphoma.

Sujith Samarasinghe, MD, discusses key results from the phase 2 ALLTOGETHER 1 DS trial in Down Syndrome B-cell acute lymphoblastic leukemia.

Suzanne Trudel, MSc, MD, discusses key results and subgroup analyses from the phase 3 DREAMM-7 trial of BVd in relapsed/refractory multiple myeloma.

Adding fixed-duration glofitamab-gxbm (Columvi) to gemcitabine and oxaliplatin led to a statistically significant and clinically meaningful improvement in survival vs rituximab (Rituxan) plus gemcitabine/oxaliplatin in patients with relapsed/refractory diffuse large B-cell lymphoma not eligible for autologous stem cell transplant.

Consuelo Bertossi, MD, discusses the role of TP53 mutations and their prognostic significance in chronic lymphocytic leukemia.

Michael R. Grunwald, MD, FACP, discusses disease progression in patients with low-risk myelofibrosis enrolled in the prospective MOST study.

Frontline toripalimab plus bevacizumab improved progression-free survival and overall survival vs sorafenib in patients with advanced hepatocellular carcinoma.

The European Commission has approved alectinib for adjuvant use in adult patients with ALK+ non–small cell lung cancer at high risk of recurrence.

China’s National Medical Products Administration has accepted the biologics license application for zanidatamab in second-line HER2+ biliary tract cancer.

Timothy Hughes, MD, MBBS, FRACP, FRCPA discussed findings from the ASC4FIRST trial comparing asciminib vs investigator-selected TKIs in CP-CML.

The European Commission granted orphan drug designation to UCART22 for acute lymphoblastic leukemia.

Jean-Marc Classe, MD, PhD, discusses lymphadenectomy omission following cytoreductive surgery after chemotherapy in advanced epithelial ovarian cancer.

The European Medicines Agency’s CHMP has recommended the approval of frontline osimertinib plus chemotherapy for EGFR-mutated non–small cell lung cancer.

Thierry Facon, MD, discusses findings from the phase 3 IMROZ trial investigating Isa-VRd in patients with newly diagnosed multiple myeloma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion for Avzivi, a monoclonal antibody referencing bevacizumab.