Key Developments

In June 2023, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorization for the medicinal product nivolumab (Opdivo), an immune checkpoint inhibitor when used in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable NSCLC at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥1%.
In September 2022, the University of Texas MD Anderson Cancer Center and Virogin Biotech, a biotechnology company, announced a strategic collaboration to accelerate the development of oncolytic virus research and development for treating advanced cancers. This collaboration brings together MD Anderson’s clinical trials expertise and infrastructure with Virogin’s innovative pipeline of investigational oncolytic viruses and support the clinical development of Virogin’s therapies with multiple clinical trials in various cancer types to evaluate the safety and clinical benefit of these therapies and to identify prognostic biomarkers of response.
In March 2022, Merck KGaA, a biopharmaceutical company, announced that the U.S. Food and Drug Administration had approved pembrolizumab (Keytruda) as a single agent for patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Pembrolizumab is a PD-1 checkpoint inhibitor for a subset of patients with endometrial carcinoma that is microsatellite instability high or mismatch repair deficient
In January 2022, Immunocore Ltd., a biotechnology company, announced that the U.S. Food and Drug Administration had approved tebentafusp-tebn (Kimmtrak), a bispecific gp100 peptide-HLA-directed CD3 T cell engager, for HLA-A 02:01-positive adult patients with unresectable or metastatic uveal melanoma.