Global Oncology

Japan approved subcutaneous pembrolizumab and berahyaluronidase alfa across all indications for which intravenous pembrolizumab is approved in the country.

The CHMP recommended perioperative pembrolizumab plus enfortumab vedotin for resectable muscle-invasive bladder cancer.

The CHMP recommended approval of adjuvant T-DXd for HER2-positive early breast cancer with residual invasive disease after neoadjuvant therapy.

CHMP has recommended EU marketing authorization for relacorilant combined with nab-paclitaxel in platinum-resistant ovarian cancer.

The positive CHMP opinion for teclistamab in second- and later-line relapsed/refractory multiple myeloma is supported by MajesTEC-9 data.

CHMP offerred a positive opinion supporting extension of melflufen to third-line, lenalidomide-refractory multiple myeloma.

Japan approved T-DXd plus pertuzumab for HER2-positive disease and Dato-DXd for triple-negative disease in first-line metastatic breast cancer.

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T-DXd plus pertuzumab was approved in the European Union as first-line treatment for unresectable or metastatic HER2-positive breast cancer.

The combination met its primary end point in the phase 3 SANOVO trial, though full efficacy and safety data have not yet been reported.

The selective ROCK2 inhibitor TDI01 generated organ-wide responses in previously treated moderate-to-severe chronic graft-versus-host disease, with the 400-mg dose performing best.

The conditional approval of fanregratinib is supported by pivotal phase 2 data showing a 42.5% objective response rate in pretreated FGFR2-altered intrahepatic cholangiocarcinoma.

Ivonescimab plus chemotherapy significantly improved overall survival vs durvalumab plus chemotherapy in advanced biliary tract cancer.

Patients who received MBTF prior to allo-HSCT achieved promising survival outcomes and manageable safety in relapsed/refractory acute myeloid leukemia.

The European Commission approved sacituzumab govitecan plus pembrolizumab for treatment-naive, PD-L1–positive, metastatic triple-negative breast cancer.

The NMPA accepted the NDA for the PD-L1/4-1BB–directed bispecific antibody opamtistomig in previously treated advanced extrapulmonary NEC.

The European Commission approved teclistamab plus daratumumab for relapsed/refractory multiple myeloma after at least 1 prior therapy, offering the regimen as early as second line.

T-DXd plus pertuzumab was approved in China as first-line treatment for unresectable or metastatic HER2-positive breast cancer.

Natera has submitted Signatera to Japan's PMDA for approval as a companion diagnostic in muscle-invasive bladder cancer.

Dato-DXd was approved in the European Union as monotherapy for patients with first-line metastatic TNBC who are not candidates for immunotherapy.

The CHMP recommended EU approval of T-DXd plus pertuzumab as first-line therapy for HER2-positive metastatic breast cancer,

The CHMP has recommended the approval of sacituzumab govitecan/pembrolizumab for treatment-naive, PD-L1-positive metastatic TNBC in the European Union.

Camizestrant plus a CDK4/6 inhibitor was approved in the European Union for ER-positive, HER2-negative advanced breast cancer with an emergent ESR1 mutation.

An updated HARMONi analysis showed a consistent OS benefit with ivonescimab plus chemotherapy in EGFR-mutated NSCLC.

Laure-Anne Teuwen, MD, PhD, debates the real-world advantages of subcutaneous pembrolizumab.