Global Oncology

Nuvisertib has received orphan drug designation from the EMA for patients with myelofibrosis.

A supplemental application has been submitted to Brazil’s health regulatory agency, seeking the approval of tafasitamab for follicular lymphoma.

Ivonescimab plus chemotherapy is under review in China for the frontline treatment of patients with advanced squamous non–small cell lung cancer.

Health Canada has expanded the approval of asciminib to include newly diagnosed and pretreated Ph-positive CML.

DZD8586 was active with a tolerable safety profile in heavily pretreated, relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

The EMA’s CHMP recommended the approval of vimseltinib for symptomatic tenosynovial giant cell tumor.

Perioperative tislelizumab received a positive CHMP opinion for resectable non–small cell lung cancer at high risk of recurrence.

The CHMP has issued a positive opinion for the use of vorasidenib in IDH1/IDH2-mutant grade 2 glioma

The European Commission has approved cabozantinib for the treatment of patients with pancreatic and extrapancreatic neuroendocrine tumors.

The European Commission and Health Canada have approved belantamab mafodotin-based combinations for relapsed/refractory multiple myeloma.

The European Commission has approved inavolisib plus palbociclib/fulvestrant in PIK3CA-mutant ER-positive, HER2-negative advanced breast cancer.

Subcutaneous daratumumab received EU approval for the treatment of patients with smoldering multiple myeloma at high risk of developing multiple myeloma.

Ibrutinib has received an expanded indication from the European Commission for the treatment of patients with newly diagnosed MCL eligible for transplant.

Among patients with advanced melanoma and the target HLA type—representing 80% of the study population—treatment with iSCIB1+ yielded an ORR of 69%.

Mirdametinib received conditional EU approval for treating NF1-associated plexiform neurofibromas in patients 2 years of age and older.

The European Commission approved obe-cel for adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia.

Darolutamide receives EU approval with ADT for metastatic hormone-sensitive prostate cancer.

Mats Jerkeman, MD, discusses long-term follow-up data of the Nordic MCL2 and MCL3 trials in younger patients with mantle cell lymphoma.

Regorafenib plus trifluridine/tipiracil was active in patients with pretreated metastatic colorectal cancer.

The European Commission has approved tislelizumab plus gemcitabine/cisplatin for adults with recurrent or metastatic nasopharyngeal carcinoma.

Bexobrutideg received European Medicines Agency orphan drug designation for Waldenström macroglobulinemia.

The EHA-EMN guidelines now include melphalan flufenamide for certain patients with relapsed/refractory multiple myeloma.

The combination of nogapendekin alfa inbakicept and BCG is now approved in the United Kingdom for the treatment of patients with NMIBC with CIS.

European approval is being sought for the combination of niraparib, abiraterone acetate, and prednisone or prednisolone for HRR-mutated mHSPC.

Nivolumab plus ipilimumab maintained an ORR benefit across subgroups of Chinese patients with unresectable hepatocellular carcinoma.