Global

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.

Vorasidenib has been granted regulatory submission acceptance by the FDA and EMA for IDH-mutant diffuse glioma.

Neoadjuvant tislelizumab plus platinum-based doublet chemotherapy followed by surgery and adjuvant tislelizumab demonstrated efficacy in resectable non–small cell lung cancer.

The European Medicines Agency has granted orphan drug designation to UV1 in patients with mesothelioma.

The EMA is evaluating a Type II extension of indication application for the approval of first-line amivantamab plus lazertinib in EGFR-mutated NSCLC.

NXC-201 has received orphan drug designation from the European Commission for use in patients with amyloid light-chain amyloidosis.

Health Canada will review the new drug submission seeking the approval of momelotinib in patients with myelofibrosis.

The MAA seeking the approval of tisotumab vedotin in select patients with recurrent or metastatic cervical cancer has been validated by the EMA.

The EMA has accepted for review an MAA seeking the approval of linvoseltamab for use in select patients with relapsed/refractory multiple myeloma.

A sNDA seeking approval of enfortumab vedotin plus pembrolizumab for first-line use in patients with urothelial cancer has been submitted to Japan’s MHLW.

Momelotinib gets market authorization from the European Commission for patients with MPNs and disease-related splenomegaly or moderate to severe anemia.

The EMA's CHMP has recommended the approval of idecabtagene vicleucel in patients with multiple myeloma who received at least 2 prior therapies.

Olverembatinib has been added to the NCCN's latest 2024 guidelines for management of chronic myeloid leukemia.

NICE has recommended talazoparib for the treatment of patients with advanced or metastatic HER2-negative breast cancer with germline BRCA1/2 mutations.

Kohei Shitara, MD, discusses first-line nivolumab plus chemotherapy vs chemotherapy alone in gastric cancer, GEJ cancer, or esophageal adenocarcinoma.

Riccardo Lencioni, MD, FSIR, EB, discusses the EMERALD-1 trial of TACE/durvalumab/bevacizumab in patients with unresectable hepatocellular carcinoma.

Thomas Powles, MD, MBBS, MRCP, discusses the use of enfortumab vedotin plus pembrolizumab in urothelial carcinoma based on data from the KEYNOTE-A39 trial.

The European Commission granted marketing authorization for SC atezolizumab co-formulated with Enhanze for all approved indications of IV atezolizumab.

The European Medicines Agency has granted orphan drug designation to pimicotinib for use in patients with inoperable tenosynovial giant cell tumor.

An MAA seeking the approval of lazertinib plus amivantamab in the first-line treatment of adult patients with EGFR+ NSCLC has been submitted to the EMA.

The China National Medical Products Administration has accepted the NDA seeking approval of sovleplenib in patients with primary immune thrombocytopenia.

The European Commission has granted conditional marketing authorization to adagrasib for patients with KRAS G12C+ advanced non–small cell lung cancer.

China’s NMPA has accepted the sNDA seeking the approval of cadonilimab plus chemotherapy for use in select patients with gastric or GEJ adenocarcinomas.

Rupert Bartsch, MD, discusses findings from the final analysis of the phase 2 TUXEDO-1 trial of trastuzumab deruxtecan in patients with HER2-positive breast cancer with active brain metastases.

The European Medicines Agency has validated its marketing authorization application for repotrectinib in adult patients with ROS1 TKI-naive or -pretreated locally advanced or metastatic non–small cell lung cancer harboring ROS1 fusions, as well as adult and pediatric patients with TKI-naive and pretreated NTRK-positive locally advanced or metastatic solid tumors.

The National Medical Products Administration of China has approved sugemalimab paired with fluorouracil and platinum-based chemotherapy for use in the frontline treatment of patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

The European Commission has approved new indications for pembrolizumab in combination with chemotherapy in select patients with gastric or gastroesophageal adenocarcinoma and select patients with biliary tract cancer.