Global Oncology

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.

Arndt Vogel, MD, on the final overall survival data for camrelizumab plus rivoceranib in unresectable hepatocellular carcinoma.

Byoung Chol Cho, MD, PhD, discusses findings from the CHRYSALIS-2 trial of amivantamab plus lazertinib in patients with atypical EGFR-mutant NSCLC.

Viktor Grünwald, MD, PhD, on patterns of progression and subsequent therapy for patients with advanced RCC treated during the phase 3 CLEAR trial.

Ivonescimab monotherapy improved PFS vs pembrolizumab in the first-line treatment of PD-L1–positive NSCLC in China.

The European Commission approved nivolumab plus cisplatin and gemcitabine for first-line treatment in unresectable or metastatic urothelial carcinoma.

Marketing authorization applications for the denosumab biosimilar HLX14 have been validated by the EMA.

Kohei Shitara, MD, discusses the background of the phase 3 CheckMate 649 study in advanced gastric cancer, GEJ cancer, and esophageal adenocarcinoma.

Two biosimilars for reference denosumab have received marketing authorization from the European Commission.

Olaparib, durvalumab, and fulvestrant produced a 66.7% 24-week PFS rate in patients with endocrine-resistant, ER-positive, HER2-negative breast cancer.