Global

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.

The EMA's CHMP has recommended the conditional marketing authorization of odronextamab for relapsed/refractory FL and DLBCL.

Osimertinib received approval in China in combination with pemetrexed and platinum-based chemotherapy for patients with advanced EGFR-mutant NSCLC.

The Japanese PMDA has approved first-line osimertinib plus chemotherapy for EGFR-mutated advanced non–small cell lung cancer.

China’s NMPA approved toripalimab plus nab-paclitaxel for the first-line treatment of recurrent or metastatic triple-negative breast cancer.

The Ministry of Health, Labour, and Welfare in Japan has approved momelotinib for use in patients with myelofibrosis.

An expanded indication for dostarlimab plus chemotherapy for all adult patients with primary advanced or recurrent endometrial cancer is under EMA review.

Valemetostat tosilate has been approved by the Japan Ministry of Health, Labor and Welfare for the treatment of patients with relapsed/refractory PTCL.

The European Commission has approved fruquintinib for select patients with pretreated metastatic colorectal cancer.

The EMA has validated an extension application for the subcutaneous formulation of nivolumab in adult patients with solid tumor indications.

Tafasitamab plus lenalidomide has been granted priority review in China for transplant-ineligible, relapsed/refractory diffuse large B-cell lymphoma.

Capivasertib/fulvestrant was approved in the EU for pretreated, ER-positive, HER2‑negative advanced cancer with 1 or more PIK3CA, AKT1, or PTEN alterations.

Golidocitinib has received approval from China’s NMPA for relapsed/refractory peripheral T-cell lymphoma.

Sujith Samarasinghe, MD, discusses key results from the phase 2 ALLTOGETHER 1 DS trial in Down Syndrome B-cell acute lymphoblastic leukemia.

Suzanne Trudel, MSc, MD, discusses key results and subgroup analyses from the phase 3 DREAMM-7 trial of BVd in relapsed/refractory multiple myeloma.

Adding fixed-duration glofitamab-gxbm (Columvi) to gemcitabine and oxaliplatin led to a statistically significant and clinically meaningful improvement in survival vs rituximab (Rituxan) plus gemcitabine/oxaliplatin in patients with relapsed/refractory diffuse large B-cell lymphoma not eligible for autologous stem cell transplant.

Consuelo Bertossi, MD, discusses the role of TP53 mutations and their prognostic significance in chronic lymphocytic leukemia.

Michael R. Grunwald, MD, FACP, discusses disease progression in patients with low-risk myelofibrosis enrolled in the prospective MOST study.