Global Oncology

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.

Nadofaragene firadenovec was safe and produced high CR rates at 3 months in Japanese patients with high-risk BCG-unresponsive NMIBC and CIS.

Pembrolizumab/chemotherapy was approved by Health Canada for the treatment of patients with unresectable advanced or metastatic pleural mesothelioma.

China’s NMPA has accepted an sNDA for review, seeking the approval of repotrectinib for advanced solid tumors harboring NTRK fusions.

Dostarlimab/chemotherapy was granted an expanded approval by Health Canada to treat patients with primary advanced or first recurrent endometrial cancer.