Global Oncology

The EMA’s CHMP has issued a positive opinion for mirdametinib for pediatric and adult patients with NF1-associated plexiform neurofibromas.

Multiple experts on artificial intelligence in cancer care discuss its ever-expanding role in several areas of oncology.

Osimertinib, with conditions, has been approved by Health Canada for locally advanced, unresectable NSCLC, harboring EGFR mutations.

Tafasitamab plus lenalidomide has received NMPA approval for patients with relapsed/refractory DLBCL who are ineligible for ASCT.

Two belantamab mafodotin–based combinations have been approved in Japan for relapsed/refractory multiple myeloma.

First-line cemiplimab extended median PFS and OS vs chemotherapy in patients with untreated advanced NSCLC with brain metastases.

China’s NMPA approved bireociclib for 2 indications in adult patients with HR+/HER2– breast cancer.

Perioperative nivolumab plus chemotherapy was approved by the European Commission for use in resectable PD-L1–positive non–small cell lung cancer.

Switzerland has approved piflufolastat (18F) as an imaging agent to detect PSMA-positive lesions in prostate cancer.

Capecitabine/bevacizumab had favorable efficacy and safety profiles among older patients with metastatic colorectal cancer.

Disitamab vedotin plus toripalimab improved PFS and OS vs chemotherapy in HER2-expressing metastatic urothelial carcinoma.

BTK mutations occurred at low rates in patients with CLL who had disease progression after receiving zanubrutinib or ibrutinib in the phase 3 ALPINE study.

The Czech Republic’s State Institute for Drug Control has approved the Illuccix PSMA-PET imaging kit in adult patients with prostate cancer.

SCG101 T-cell therapy was safe and induced sustained HBV clearance and antitumor activity in patients with advanced HBV-related hepatocellular carcinoma.

The European Commission has approved acalabrutinib plus bendamustine and rituximab for previously untreated, transplant-ineligible mantle cell lymphoma.

A priority review was granted to zurletrectinib in China for the treatment of patients with NTRK gene fusion–positive advanced solid tumors.

The EMA’s CHMP has recommended at-home administration of pertuzumab, trastuzumab and hyaluronidase combination therapy for HER2+ breast cancer.

The EMA’s CHMP has recommended the approval for acalabrutinib/venetoclax with or without obinutuzumab in untreated CLL.

China’s NMPA approved ivonescimab for the first-line treatment of PD-L1–positive advanced non–small cell lung cancer.

Linvoseltamab earned EC approval for relapsed/refractory multiple myeloma after at least 3 prior lines of therapy.

The EMA’s CHMP issued a positive opinion for zanidatamab in previously treated HER2-positive biliary tract cancer.

The EMA’s CHMP has recommended the approval of brentuximab vedotin plus ECADD for newly diagnosed, stage IIB/III/IV Hodgkin lymphoma.

China’s NMPA has approved orelabrutinib for the first-line treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma.

China’s NMPA has approved the sNDA for toripalimab as a first-line treatment for patients with unresectable or metastatic melanoma.

Japan’s Ministry of Health has received a supplemental new drug application for T-DXd for HER2-positive advanced or recurrent solid tumors.