Global Oncology

The European Commission has approved imetelstat for the treatment of patients with transfusion-dependent anemia in lower-risk myelodysplastic syndrome.

Amivantamab plus lazertinib was approved in Canada for first-line EGFR-mutated locally advanced or metastatic non–small cell lung cancer.

The Chinese NMPA has approved sacituzumab tirumotecan for EGFR-mutant advanced NSCLC following progression on an EGFR TKI and chemotherapy.

China’s NMPA has accepted an MAA seeking the approval of foritinib for ALK-positive advanced non–small cell lung cancer.

Nivolumab plus ipilimumab was approved by the European Commission for first-line, unresectable or advanced HCC.

First-line olverembatinib plus low-intensity chemotherapy has received breakthrough therapy designation in China for patients with Ph-positive ALL.

NOMA has approved the PET imaging agent for the identification of PSMA-positive lesions in patients with prostate cancer.

Regina Barragan-Carrillo, MD, discusses a study of RCC clinical trial availability and barriers to opening RCC clinical trials in lower-income countries.

The CHMP has recommended the approval of perioperative durvalumab plus neoadjuvant chemotherapy for patients with resectable NSCLC.

The CHMP has recommend the approval of subcutaneous daratumumab plus VRd for newly diagnosed multiple myeloma.

CHMP has recommended glofitamab plus gemcitabine and oxaliplatin for R/R DLBCL.

The CHMP has recommended the European approval of pirtobrutinib for relapsed/refractory CLL previously treated with a covalent BTK inhibitor.

The CHMP has issued a positive opinion for linvoseltamab in relapsed/refractory multiple myeloma.

The CHMP has recommended the approval of trastuzumab deruxtecan for HER2-low or HER2-ultralow metastatic breast cancer.

China’s NMPA has granted priority review to an NDA for neoadjuvant ipilimumab injection plus sintilimab in MSI-H or dMMR colon cancer.

Isatuximab plus VRd has been approved in Japan for transplant-ineligible, newly diagnosed multiple myeloma.

The Ministry of Health, Labour, and Welfare in Japan has approved epcoritamab for relapsed or refractory follicular lymphoma.

The FDA and European Commission have approved 2 biosimilars referencing denosumab for cancer-related bone loss and other indications.

The UK Medicines and Healthcare Products Regulatory Agency has approved the kit for the preparation of gallium-68 gozetotide injection.

Phase 1 study data demonstrated that ATG-022 has a manageable safety profile and produced activity in patients with gastric cancer and CLDN 18.2 expressions.

The European Commission has approved serplulimab in combination with carboplatin and etoposide for the frontline treatment of adult patients with ES-SCLC.

The EMA’s CHMP has issued a positive opinion supporting the approval of subcutaneous amivantamab in EGFR-mutated NSCLC.

The CHMP has recommended approval for durvalumab in limited-stage small cell lung cancer following platinum-based chemoradiation.

Datopotamab deruxtecan approaches approval in Europe as an option for patients with previously treated hormone receptor–positive breast cancer.

The EMA’s CHMP has adopted a positive opinion regarding frontline nivolumab plus ipilimumab in unresectable or advanced hepatocellular carcinoma.