European Medicines Agency Recommends T-DXd for Approval in European Union in Advanced HER2+ Breast CancerJune 29th 2022
The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended for approval trastuzumab deruxtecan for patients with unresectable or metastatic HER2-positive breast cancer.
European Commission Approves Capmatinib in NSCLC With MET Exon 14 Skipping MutationJune 22nd 2022
Based on results from the phase 2 GEOMETRY mono-1 trial, the European Commission has approved capmatinib for patients with non–small cell lung cancer who have MET exon 14 skipping mutations, and a need for systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
UK’s MHRA Accepts Marketing Authorization Application for Aumolertinib in EGFR+ Advanced NSCLCJune 21st 2022
Results from the phase 3 AENA trial led to the United Kingdom’s Medicine and Healthcare products Regulatory Agency accepting a marketing authorization application for aumolertinib for review in patients with locally advanced or metastatic non–small cell lung cancer with activating EGFR mutations, and those with locally advanced or metastatic EGFR T790M mutation–positive non–small cell lung cancer.
Tislelizumab Approved By China NMPA for Recurrent or Metastatic Nasopharyngeal CancerJune 14th 2022
Based on results of the phase 3 RATIONALE-309 trial, the China National Medical Products Administration has approved tislelizumab plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal cancer.
Neoadjuvant Pembrolizumab/Chemotherapy Approved by European Commission for Locally Advanced, Early-Stage TNBCMay 29th 2022
European patients with locally advanced or early-stage triple-negative breast cancer at high risk of recurrence can now receive treatment with neoadjuvant pembrolizumab and chemotherapy, as well as pembrolizumab monotherapy post surgery following its approval by the European Commission.
Final PFS Analysis Shows Promise of Sugemalimab in Stage III Non–Small Cell Lung CancerMay 18th 2022
Final end point analysis of the GEMSTONE-301 trial confirmed that patients with stage III non–small cell lung cancer experienced significant clinical benefit and promising efficacy following consolidation therapy with sugemalimab monotherapy.
European Commission Approves Pembrolizumab Plus Chemotherapy With or Without Bevacizumab for Cervical CancerMay 3rd 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 CancerApril 16th 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.
Hong Kong Department of Health Approves Pemigatinib for Adults With FGFR2+ Locally Advanced/Metastatic CholangiocarcinomaJanuary 25th 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.
Sugemalimab Study Meets Primary End Point for Refractory Extranodal Natural Killer/T-Cell Lymphoma, Moves Forward With NMPA of ChinaJanuary 19th 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.