European Commission Grants Approval to Second-Line Axicabtagene Ciloleucel for R/R DLBCL/HGBL
October 22nd 2022The European Commission based its approval of axicabtagene ciloleucel as a second-line therapy for patients with relapsed/refractory diffuse large B-cell lymphoma or high-grade B-cell lymphoma on the efficacy findings of the phase 3 ZUMA-7 trial.
Pembrolizumab Granted 4 Approvals in Japan for High-Risk TNBC, RCC, and More
October 2nd 2022Japan’s Ministry of Health, Labor and Welfare approved pembrolizumab for use in 4 indications, including high-risk, early-stage triple-negative breast cancer, stage IIB or IIC melanoma, adjuvant renal cell carcinoma, and recurrent/metastatic cervical cancer.
First-Line Olaparib/Bevacizumab Maintenance Combo Approved in China for HRD+ Advanced Ovarian Cancer
September 23rd 2022Olaparib and bevacizumab has been approved in China as a frontline maintenance treatment for patients with advanced homologous recombination deficiency–positive ovarian cancer based on results from the phase 3 PAOLA-1 trial.
EMA Gives Positive CHMP Opinion for Teclistamab Relapsed/Refractory Myeloma Indication
July 27th 2022Patients with relapsed/refractory multiple myeloma appear to benefit from treatment with teclistamab, which was given a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use.
European Commission Approves Capmatinib in NSCLC With MET Exon 14 Skipping Mutation
June 22nd 2022Based 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 NSCLC
June 21st 2022Results 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 Cancer
June 14th 2022Based 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.
Final PFS Analysis Shows Promise of Sugemalimab in Stage III Non–Small Cell Lung Cancer
May 18th 2022Final 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.