Global Oncology

The new drug application for sintilimab plus fruquintinib has been granted priority review by the NMPA for pMMR/non-MSI-H advanced endometrial cancer.

China’s NMPA accepted a sBLA for enfortumab vedotin plus pembrolizumab for the first-line treatment of locally advanced or metastatic urothelial cancer.

Ibrutinib with or without rituximab was effective and tolerable in patients with previously untreated, low-risk mantle cell lymphoma.

China’s NMPA has accepted an sNDA for approval of savolitinib for treatment-naive locally advanced/metastatic NSCLC with MET exon 14 skipping alterations.

The European Commission has approved neoadjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab, for high-risk, resectable NSCLC.

Investigators emphasize the importance of firming a widely understood definition of unmet needs in cancer care due to their impact on drug approvals.

The Japanese Ministry of Health, Labour and Welfare has approved zolbetuximab for CLDN18.2-positive, unresectable, advanced or recurrent gastric cancer.

The EMA’s CHMP has recommended the approval of enzalutamide with or without androgen deprivation therapy in biochemically recurrent nmHSPC.

The European Commission has approved idecabtagene vicleucel for triple-class–exposed relapsed/refractory multiple myeloma.

Christian Marth, MD, PhD, discusses the LEAP-001 trial of lenvatinib plus pembrolizumab vs chemotherapy in advanced or recurrent endometrial cancer.

Mansoor Raza Mirza, MD, discusses findings from part 2 of the ENGOT-EN6-NSGO/GOG-3031/RUBY trial in primary advanced or recurrent endometrial cancer.

China’s NMPA has approved tunlametinib for the treatment of patients with NRAS-mutated advanced melanoma after prior anti–PD-1/PD-L1 therapy.

A new drug application seeking the approval of Dato-DXd for pretreated HR-positive, HER2-negative advanced breast cancer has been filed in Japan.

Tinengotinib has been awarded orphan drug designation from the European Medicines Agency for use in select patients with biliary tract cancer.

The EMA has received a type II variation application for an indication extension of D-VRd for the treatment newly diagnosed multiple myeloma.

R. Lor Randall, MD, FACS, discusses the top takeaways from the inaugural 2024 Birmingham Orthopedic Oncology Meeting.

China’s National Medical Products Administration has accepted the second NDA for first-line taletrectinib for ROS1-positive non–small cell lung cancer.

The National Institute for Health and Care Excellence recommends the approval of dostarlimab plus chemotherapy for advanced/recurrent endometrial cancer.

China’s NMPA has approved zevor-cel for the treatment of adult patients with relapsed/refractory multiple myeloma after at least 3 lines of therapy.

HIPEC was not associated with additional complications or worse survival in patients with FIGO stage IV ovarian cancer vs those with stage III disease.

Most oncology drugs approved by the EMA recover research and development costs within a few years, even if the drug is providing little added benefit.

The European Medicines Agency has validated a marketing authorization application seeking the approval of nirogacestat for patients with desmoid tumors.

The European Medicines Agency’s CHMP has recommended the approval of tislelizumab in the first- and second-line for non–small cell lung cancer.

Pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab has been recommended for approval in high-risk NSCLC by the EMA's CHMP.

Swissmedic has accepted for review a marketing authorization application seeking the approval of Piflufolastat (18F) for prostate cancer.