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All Oncology News

The FDA has granted an approval to a prefilled syringe for lanreotide (Somatuline Depot), which has been designed to enable healthcare providers to administer the injection easier, for the treatment of adults with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors.

The FDA has lifted a partial clinical hold that was placed on the phase III CANOVA (M13-494; NCT03539744) trial, which is examining venetoclax in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma that harbors t(11;14), according to AbbVie, the company that co-develops the BCL-2 inhibitor with Roche.

The FDA has granted a priority review designation to a supplemental biologics license application for niraparib for the treatment of patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with ≥3 or more prior chemotherapy regimens, and who have either a BRCA mutation or have homologous recombination deficiency and progressed >6 months after their last platinum-based chemotherapy.

Nivolumab (Opdivo) did not achieve statistical significance for improved overall survival compared with sorafenib (Nexavar) as a frontline therapy for patients with unresectable hepatocellular carcinoma as per a prespecified analysis, missing the primary endpoint of the phase III CheckMate-459 trial.

The European Commission has approved olaparib as a single agent for the maintenance treatment of adult patients with advanced BRCA1/2-mutated germline and/or somatic high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response following first-line platinum-based chemotherapy.

The FDA has granted an accelerated approval to single-agent pembrolizumab for the treatment of patients with metastatic small cell lung cancer who have disease progression on or after platinum-based chemotherapy and ≥1 other prior line of therapy.