The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the extension of the marketing authorization of Adcetris (brentuximab vedotin) and recommended its approval in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, and dexamethasone, a chemotherapy regimen, in adult patients with newly diagnosed stage 2b with risk factors/3/4 Hodgkin lymphoma.
The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended a fixed-duration regimen of Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab for approval in the EU for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia.
FDA approved penpulimab-kcqx with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma. FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
BrainChild Bio Inc. announced that its investigational B7-H3 targeting autologous CAR T-cell therapy has been granted Breakthrough Therapy designation by FDA for the treatment of diffuse intrinsic pontine glioma, an incurable pediatric brain tumor.
FDA on April 11 approved nivolumab (Opdivo) with ipilimumab (Yervoy) for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma.
FDA announced on April 10 its efforts to advance public health by replacing animal testing in the development of monoclonal antibody therapies and other drugs with more effective, human-relevant methods.
FDA granted full approval for Vitrakvi (larotrectinib), a first-in-class TRK inhibitor for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.
FDA approved Biocon Biologics Ltd’s Jobevne (bevacizumab-nwgd), a biosimilar bevacizumab for intravenous use. Jobevne, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin (bevacizumab).
FDA approved AstraZeneca’s durvalumab (Imfinzi) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer.
AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab has been recommended for approval in the EU for the treatment of adult patients with previously untreated mantle cell lymphoma who are not eligible for autologous hematopoietic stem cell transplantation.
