Global Oncology

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.

Idecabtagene vicleucel has received marketing and manufacturing approval in Japan for its supplemental new drug application in patients with relapsed/refractory multiple myeloma who have received at least 2 prior lines of therapy.

Axatilimab induced rapid and durable responses with an acceptable toxicity profile at all doses analyzed with highest efficacy observed at the 0.3-mg/kg dose in patients with recurrent or refractory chronic graft-vs-host disease.

The European Medicines Agency has validated a type II application for the investigational T-cell engaging bispecific antibody epcoritamab-bysp for patients with relapsed/refractory follicular lymphoma following at least 2 prior lines of therapy

The Center for Drug Evaluation of China’s National Medical Products Administration has accepted the new drug application seeking the approval of the next-generation ROS1 TKI taletrectinib for the treatment of patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer with prior exposure to a ROS1 TKI.