FDA Grants Priority Review to BLA for Vicineum for Treatment of High-Risk, BCG-Unresponsive NMIBC
February 18th 2021The biologics license application is for the locally administered fusion protein Vicineum for the treatment of high-risk, bacillus Calmette-Guérin (BCG)–unresponsive non-muscle invasive bladder cancer.
FDA Accepts sNDA for Zanubrutinib for Treatment of Waldenström Macroglobulinemia
February 17th 2021A supplemental new drug application submission was primarily based on safety and efficacy data from the global phase 3 ASPEN trial of zanubrutinib compared with ibrutinib for the treatment of Waldenström macroglobulinemia.
Salma Jabbour, MD, on the Results of the Ongoing KEYNOTE-799 Study
February 17th 2021The chief of Gastrointestinal Radiation Oncology at the Rutgers Cancer Institute of New Jersey discussed updated results from the study of pembrolizumab plus concurrent chemoradiation therapy in patients with unresectable, locally advanced, stage III non–small cell lung cancer.
FDA Grants Priority Review to Sotorasib to Treat Patients With KRAS G12C–Mutated NSCLC
February 17th 2021Amgen announced that their new drug application for sotorasib was granted priority review by the FDA to treat patients with KRAS G12C–mutated locally advanced or metastatic non–small cell lung cancer.
Adjuvant Osimertinib Does Not Adversely Affect Health-Related QOL for EGFR+ NSCLC
February 15th 2021Patients with EGFR-positive non–small cell lung cancer who received treatment with osimertinib following surgery versus placebo experienced no clinically meaningful differences in health-related quality of life, according to results of a pivotal phase 3 trial.
Jonathan Thompson, MD, MS, on AEs and Limitations Reported in the Phase 2 BGBC008 Study
February 15th 2021The trial demonstrated that combination treatment with bemcentinib and pembrolizumab was well tolerated and clinically active in patients with checkpoint inhibitor (CPI)–naïve and CPI–refractory composite AXL (cAXL)–positive non–small cell lung cancer.
FDA Approves Trilaciclib for Patients With SCLC Being Treated With Chemo
February 12th 2021The approval of trilaciclib was based on results from a pooled analysis of intent-to-treat datasets from 3 studies of patients with extensive-stage small cell lung cancer in which patients received standard chemotherapy plus either trilaciclib or placebo.
PSMA-Targeted Agent Identified Disease in Majority of Patients with Relapsed Prostate Cancer
February 12th 2021The potential to identify occult prostate cancer and accurately characterize disease burden was observed with the novel prostate specific membrane antigen (PSMA)–targeted radiopharmaceutical for PET imaging technique.