Global Oncology

A sNDA seeking the approval of toripalimab for frontline use in patients with unresectable or metastatic melanoma is under review by the NMPA.

The Nectin-4–directed antibody-drug conjugate 9MW2821 has received breakthrough therapy designation in China for pretreated, advanced urothelial carcinoma.

Trastuzumab deruxtecan elicited responses in patients with HER2-positive biliary tract cancer, according to data from a single-arm, phase 2 trial.

The European Medicines Agency has approved Avzivi, a biosimilar referencing bevacizumab.

China’s NMPA has accepted an sBLA for ivonescimab in first-line, PD-L1–positive non–small cell lung cancer.

The EMA’s CHMP has recommended toripalimab plus chemotherapy for metastatic nasopharyngeal carcinoma and advanced esophageal squamous cell carcinoma.

The EMA's CHMP has recommended zolbetuximab plus chemotherapy in select locally advanced unresectable or metastatic HER2-negative gastric or GEJ cancer.

The EMA’s CHMP has recommended the approval of amivantamab plus chemotherapy for pretreated, EGFR-mutated advanced non–small cell lung cancer.

First-line sugemalimab plus chemotherapy has been approved in Europe for metastatic non–small cell lung cancer.

The CHMP has recommended pembrolizumab plus enfortumab vedotin-ejfv in frontline unresectable or metastatic urothelial carcinoma.

NICE recommends pembrolizumab plus platinum- and fluoropyrimidine-based chemotherapy for untreated HER2-negative advanced gastric or GEJ adenocarcinoma.

Thierry Facon, MD, discusses clinical implications from the phase 3 IMROZ trial

The marketing authorization application seeking the approval of vimseltinib for the treatment of tenosynovial giant cell tumor is under EMA review.

The type II variation application for frontline nivolumab plus ipilimumab in unresectable/advanced hepatocellular carcinoma was validated by the EMA.

The EMA has accepted a marketing authorization application seeking approval of belantamab mafodotin regimens in relapsed/refractory multiple myeloma.

The National Medical Products Administration accepted for review the supplemental new drug application for toripalimab plus bevacizumab in advanced HCC.

Timothy Hughes, MD, MBBS, FRACP, FRCPA, on safety data for asciminib in Philadelphia chromosome–positive chronic-phase chronic myeloid leukemia.

Bexarotene has been granted marketing authorization in Hong Kong for the treatment of pretreated cutaneous manifestations of cutaneous T-cell lymphoma.

Health Canada has approved osimertinib/chemotherapy for advanced non–small cell lung cancer harboring EGFR exon 19 deletions or exon 21 L858R mutations.

Selinexor has received approval as monotherapy for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma in China.

Frontline osimertinib plus chemotherapy has been approved in the European Union for adult patients with advanced EGFR-mutated non–small cell lung cancer.

The EMA recommends durvalumab plus chemotherapy, followed by olaparib and durvalumab for pMMR endometrial cancer, and single-agent durvalumab for dMMR disease.

TAS-102 followed by regorafenib is an optimal sequence vs regorafenib followed by TAS-102 in select patients with metastatic colorectal cancer.

The EMA’s CHMP has recommended a conditional marketing authorization for epcoritamab for patients with relapsed/refractory follicular lymphoma.

The EMA's CHMP has adopted a positive opinion regarding erdafitinib in patients with FGFR3+ unresectable or metastatic urothelial carcinoma.