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Pfizer reports that following a preplanned efficacy and futility analysis, the independent Data Monitoring Committee (DMC) of the collaborative Phase III early breast cancer PALbociclib CoLlaborative Adjuvant Study (PALLAS) determined that the trial of Ibrance (palbociclib) plus standard adjuvant endocrine therapy is unlikely to show a statistically significant improvement in the primary endpoint of invasive disease-free survival (iDFS).
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Zercepac (trastuzumab), from Accord Healthcare, intended for the treatment of breast and gastric cancer.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Rozlytrek (entrectinib), from Roche, intended for the treatment of patients with ROS1-positive advanced non-small cell lung cancer (NSCLC). Rozlytrek will be available as hard capsules (100 and 200 mg). Rozlytrek targets cells with constitutive activation of TRK proteins resulting from gene fusions and the proto-oncogene tyrosine-protein kinase ROS (ROS1).