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Gina Columbus

Articles by Gina Columbus

The FDA has recommended that Aveo Oncology should not submit a new drug application for tivozanib with the preliminary overall survival data from the phase III TIVO-3 trial of patients with highly refractory, advanced or metastatic renal cell carcinoma.

The European Commission has approved an expanded indication for single-agent rucaparib as a maintenance therapy in adult patients with platinum-sensitive, relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy, regardless of BRCA status.

The frontline combination of ibrutinib (Imbruvica) and nab-paclitaxel (Abraxane)/gemcitabine did not show a statistically significant benefit in progression-free or overall survival versus placebo plus nab-paclitaxel/gemcitabine in patients with metastatic pancreatic cancer.

The FDA has granted an approval to SB3 (Ontruzant; trastuzumab-dttb), a trastuzumab biosimilar, for the treatment of patients with HER2-overexpressing breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma.