Global Bulletin

European Commission Approves Pembrolizumab in MSI-H/dMMR Solid Tumors
May 06, 2022

Pembrolizumab has been approved by the European Commission in 5 indications of solid tumors that are microsatellite instability–high or deficient mismatch repair.

European Commission Approves Pembrolizumab Plus Chemotherapy With or Without Bevacizumab for Cervical Cancer
May 03, 2022

Patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 can receive treatment with pembrolizumab plus chemotherapy with or without bevacizumab following approval by the European Commission.

Enfortumab Vedotin Approved by European Commission for Pretreated Locally Advanced or Metastatic Urothelial Cancer
April 16, 2022

European patients with locally advanced or metastatic urothelial cancer can now receive treatment with enfortumab vedotin following treatment with a platinum-containing regimen and a PD-(L)1 inhibitor.

Tepotinib Approved by European Commission for Advanced MET exon 14+ NSCLC
February 18, 2022

The European Commission has approved tepotinib for use in patients with advanced non–small cell lung cancer with MET exon 14 skipping alterations.

First-Line Lorlatinib Receives Approval From the European Commission for ALK+ Advanced NSCLC
January 31, 2022

The European Commission approves the use of lorlatinib for the treatment of ALK-positive advanced non–small cell lung cancer.

Hong Kong Department of Health Approves Pemigatinib for Adults With FGFR2+ Locally Advanced/Metastatic Cholangiocarcinoma
January 25, 2022

Pemigatinib is a new treatment option following approval from the Hong Kong Department of Health for patients with locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement following progression on at least 1 prior line of therapy.

Sotorasib Earns Approval in Japan for KRAS G12C+ NSCLC
January 20, 2022

The Japan Ministry of Health, Labour and Welfare granted approval to the KRAS inhibitor sotorasib for the treatment of adults with KRAS G12C–mutated non–small cell lung cancer.

Sugemalimab Study Meets Primary End Point for Refractory Extranodal Natural Killer/T-Cell Lymphoma, Moves Forward With NMPA of China
January 19, 2022

Sugemalimab showed promise in the phase 2 GEMSTONE-201 trial in a group of patients with extranodal natural killer/T-cell lymphoma; developer CStone is set to submit a new drug application for the treatment to the National Medical Products Administration of China.