FDA approved Truqap (capivasertib) with fulvestrant for adult patients with hormone receptor-positive, human epidermal growth factor receptor-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
FDA has granted approval for the HistoSonics’ Edison histotripsy device to treat liver tumors. Â
FDA approved Fruzaqla (fruquintinib), an oral targeted therapy for adults with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.Â
FDA revised the existing indication of Keytruda (pembrolizumab) with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.Â
FDA approved Keytruda (pembrolizumab) to be used with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract cancer.
FDA has approved Loqtorz (toripalimab-tpzi) with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma.Â
FDA has approved Tibsovo (ivosidenib) for adult patients with relapsed or refractory myelodysplastic syndromes with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test.
FDA has approved Keytruda (pembrolizumab) with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable (tumors ≥4 cm or node positive) non-small cell lung cancer.Â
FDA approved nivolumab (Opdivo) for the adjuvant treatment of completely resected stage 2B/C melanoma in patients 12 years and older.
Julie Beitz was named principal drug regulatory expert at Hyman, Phelps & McNamara, P.C., a law firm focused on FDA.