Gina Columbus

Articles by Gina Columbus

The FDA has expanded the approval for pembrolizumab (Keytruda) monotherapy for the frontline treatment of patients with stage III non–small cell lung cancer (NSCLC), who are ineligible for surgery or definitive chemoradiation, or metastatic NSCLC, with a PD-L1 expression (tumor proportion score [TPS]) level of ≥1% and do not harbor EGFR or ALK aberrations.

The FDA has granted an approval to PF-05280014 (Trazimera; trastuzumab-qyyp), a trastuzumab (Herceptin) biosimilar, to treat patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma

The FDA has expanded the approval of aprepitant (Cinvanti) injectable emulsion to include a 2-minute intravenous (IV) use for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV).

The FDA has approved subcutaneous use of trastuzumab (Herceptin) and hyaluronidase-oysk injection (Herceptin Hylecta) in combination with chemotherapy for the treatment of select patients with HER2-positive early breast cancer, and alone or in combination with paclitaxel in patients with metastatic HER2-positive breast cancer who have received at least 1 prior chemotherapy regimen.

Pembrolizumab (Keytruda) was found to reduce the risk of death by 31% in patients with PD-L1–positive (combined positive score [CPS] ≥10) advanced or metastatic esophageal or esophageal junction carcinoma who progressed on standard therapy, according to phase III findings of the KEYNOTE-181 trial.

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

The FDA has approved dasatinib (Sprycel) tablets in combination with chemotherapy for the treatment of pediatric patients ≥1 year of age with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).

The FDA has approved olaparib (Lynparza) as a maintenance treatment for patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to frontline platinum-based chemotherapy, as approved by an FDA-approved companion diagnostic assay.

Lisocabtagene maraleucel (liso-cel; JCAR017) appeared tolerable and induced an 81.3% best overall response rate and 43.8% complete response rate in heavily pretreated, high-risk patients with chronic lymphocytic leukemia (CLL) who previously received ibrutinib (Imbruvica), according to dose-finding results of a small phase I/II trial.