Global

Erdafitinib was approved by the European Commission for pretreated unresectable or metastatic urothelial carcinoma harboring FGFR3 alterations.

Enfortumab vedotin plus pembrolizumab has been approved by Health Canada for use in unresectable locally advanced or metastatic urothelial cancer.

China’s National Medical Products Administration has approved fulzerasib for the treatment of adult patients with advanced KRAS G12C–mutant NSCLC.

An NDA seeking approval of sacituzumab tirumotecan for select patients with EGFR+ non–small cell lung cancer has been accepted by the NMPA's CDE.

China’s National Medical Products Administration has approved enfortumab vedotin for adult patients with locally advanced or metastatic urothelial cancer.

The European Commission has granted conditional marketing authorization to epcoritamab for patients with relapsed or refractory follicular lymphoma.

The EMA has validated a type II variation application for trastuzumab deruxtecan for select patients with HER2-low or -ultralow metastatic breast cancer.

The EMA has expanded the indication for lisocabtagene maraleucel to include the treatment of patients with relapsed or refractory follicular lymphoma.

Ivonescimab has been granted priority review in China for the frontline treatment of patients with PD-L1–positive locally advanced or metastatic NSCLC.

Suzanne Trudel, MSc, MD, discusses the implications of results from the DREAMM-7 and DREAMM-8 trials in relapsed/refractory multiple myeloma.

Durvalumab plus chemotherapy, then durvalumab with or without olaparib, was approved in Europe for select advanced/recurrent endometrial cancer.

Consuelo Bertossi, MD, discusses centralized academic reference diagnostics and biobanking in prospective, multicenter clinical trials.

Trastuzumab deruxtecan earned conditional approval in China for HER2-positive gastric/gastroesophageal junction cancer after at least 2 lines of therapy.

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.