Global Oncology

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.

A CE Mark has been granted to Optune Lua concurrent with immune checkpoint inhibitors or docetaxel for patients with metastatic non–small cell lung cancer.

Pyrotinib led to high 2-year iDFS rates in the adjuvant setting following adjuvant trastuzumab-based treatment in HER2-positive breast cancer.

Ivonescimab plus chemotherapy met the primary PFS end point vs tislelizumab plus chemotherapy in advanced squamous NSCLC.

Inati-cel generated complete remissions and MRD negativity in CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia.