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Gina Columbus

Articles by Gina Columbus

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

The FDA has approved olaparib 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.

Neratinib led to a statistically significant improvement in centrally confirmed progression-free survival compared with lapatinib and capecitabine in patients with HER2-positive metastatic breast cancer who have failed 2 or more prior lines of HER2-directed therapy.

The European Medicines Agency's Committee for Medicinal Products for Human Use has granted a positive opinion to dasatinib in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended to expand the approval of 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.

Adjuvant treatment with capecitabine in patients with early-stage triple-negative breast cancer did not significantly improve disease-free or overall survival compared with observation, according to results from the phase III GEICAM/CIBOMA trial that were presented at the 2018 San Antonio Breast Cancer Symposium.

Two-year maintenance therapy with ixazomib led to a 39% improvement in progression-free survival compared with placebo in patients with newly diagnosed multiple myeloma who achieved a partial response to induction treatment with a proteasome inhibitor and/or an immunomodulatory agent following autologous stem cell transplant.

Concurrent treatment with ibrutinib and the CD19-targeted chimeric antigen receptor T-cell therapy JCAR014 was well tolerated and led to an overall response rate of 83% in patients with relapsed or refractory chronic lymphocytic leukemia.

The European Commission has granted approval to the biosimilar Ziextenzo, a biosimilar for pegfilgrastim, as a treatment to reduce the duration of neutropenia and incidence of febrile neutropenia that is associated with anticancer chemotherapy.