FDA has approved the PD-1 inhibitor Libtayo (cemiplimab-rwlc) as the first immunotherapy indicated for patients with advanced basal cell carcinoma previously treated with an hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate.
The University of Texas MD Anderson Cancer Center and Mirati Therapeutics In care collaborating to expand the evaluation of Mirati's two investigational small molecule, potent and selective KRAS inhibitors – adagrasib (MRTX849), a G12C inhibitor in clinical development, and MRTX1133, a G12D inhibitor in preclinical development, as monotherapy and in combination with other agents, which target two of the most frequent KRAS mutations in cancer.
The European Commission has granted full marketing authorization to Inrebic (fedratinib) for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis, who are Janus Associated Kinase inhibitor naïve or have been treated with ruxolitinib.
FDA has granted accelerated approval to Tepmetko (tepotinib) for adult patients with metastatic non-small cell lung cancer harboring mesenchymal-epithelial transition exon 14 skipping alterations.
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.
