Global Oncology

The EMA granted orphan designation to ADX-2191 for the management of LBCL of immune-privileged sites, including primary vitreoretinal lymphoma.

The combination of anlotinib plus chemotherapy has been approved in China for the treatment of patients with advanced soft tissue sarcoma.

As the FDA aims to reduce drug review times, the 15% tariff rate imposed on pharmaceuticals from Europe could affect drug access in the oncology space.

The European Commission approved neoadjuvant tislelizumab plus chemotherapy, followed by adjuvant tislelizumab, for resectable non–small cell lung cancer.

UM171 cell therapy has earned European Commission approval for the treatment of patients with hematologic malignancies requiring HSCT.

Ivonescimab plus chemotherapy improved overall survival in previously treated, advanced non–small cell lung cancer harboring EGFR mutations.

Trastuzumab deruxtecan has been approved in Japan for patients with HR+, HER2-low or -ultralow metastatic breast cancer.

Datopotamab deruxtecan is approved in China for hormone receptor–positive, HER2-negative metastatic breast cancer after prior endocrine therapy and chemotherapy.

Pegtarazimod has received orphan drug designation from the European Medicines Agency for the management of graft-vs-host disease.

Venetoclax plus obinutuzumab generated safe and efficacious real-world outcomes in first-line CLL with comorbidities.

Health Canada has granted marketing authorization to darolutamide for the treatment of adult patients with metastatic castration-sensitive prostate cancer.

Glofitamab plus GemOx received approval in Canada for patients with relapsed or refractory DLBCL not otherwise specified who are not eligible for ASCT.

The European approval of a zanubrutinb tablet formulation covers indications in CLL, Waldenström macroglobulinemia, MZL, and follicular lymphoma.

Alpha1H met all primary and secondary end points in a phase 2 study in non–muscle-invasive bladder cancer.

Nivolumab plus ipilimumab earned approval from Health Canada for select patients with unresectable colorectal cancer and hepatocellular carcinoma.

The NMPA has granted breakthrough therapy designation to ATG-022 for previously treated gastric and gastroesophageal junction adenocarcinoma.

The European Commission approved nirogacestat for the treatment of progressing desmoid tumors requiring systemic treatment.

PLD plus ifosfamide produced an ORR of 33% and a DCR of 83% in advanced soft tissue sarcoma, with manageable toxicity.

Bortezomib plus mitoxantrone hydrochloride liposome and dexamethasone produced responses with manageable safety in relapsed/refractory myeloma

The antibody-drug conjugate SHR-A1811 demonstrated a comparable pCR rate to SHR-A1811/pyrotinib and PCbHP in HER2-positive breast cancer.

Treatment with the combination of anlotinib and toripalimab produced durable efficacy in soft tissue sarcoma and bone sarcoma.

Perioperative pembrolizumab has received the green light for use in combination with radiotherapy with or without cisplatin in PD-L1–positive HNSCC.

Real-world data supported the clinical effectiveness of first-line palbociclib plus endocrine therapy in HR-positive, HER2-negative breast cancer.

The FDA has cleared iPETcertum for PET and PET-CT/MRI scan enhancement in patients with cancer and suspicious lesions.

Extended follow-up showed sintilimab plus anlotinib yielded durable efficacy and tolerability in PD-L1–positive recurrent/metastatic cervical cancer.