The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of an expanded label for Keytruda (pembrolizumab).
FDA has approved a combination of Opdivo (nivolumab) and Cabometyx (cabozantinib) as first-line treatment for patients with advanced renal cell carcinoma.
The European Commission has approved Keytruda as a monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.
FDA has approved Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma who have received a prior trastuzumab-based regimen.
FDA has granted accelerated approval to Darzalex Faspro (daratumumab plus hyaluronidase) in combination with bortezomib, cyclophosphamide and dexamethasone for newly diagnosed light chain (AL) amyloidosis.
FDA has accepted the supplemental Biologics License Application of Opdivo (nivolumab) for the treatment of patients with resected esophageal or gastroesophageal junction cancer in the adjuvant setting, after neoadjuvant chemoradiation therapy.
FDA has accepted the supplemental Biologics License Application for Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma.
FDA has made labeling updates for the preparation of vinca alkaloids, a group of chemotherapy agents that includes vincristine sulfate injection, vinblastine sulfate (for) injection, and vinorelbine tartrate injection.
FDA has approved Xalkori (crizotinib) for pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma that is ALK-positive.
FDA has granted orphan drug designation to Pvsripo for the treatment of advanced melanoma (stage IIB-IV).
