FDA Grants Priority Review to sNDA for Ruxolitinib to Treat Steroid-Refractory cGVHD
February 23rd 2021The sNDA submission for ruxolitinib to treat steroid-refractory chronic graft-versus-host disease in adult and pediatric patients 12 years and older was based on the phase 3 REACH3 study, which is assessing the safety and efficacy of ruxolitinib compared with best available therapy.
FDA Approves Cemiplimab as First-Line Treatment for Advanced, High PD-L1 NSCLC
February 22nd 2021The approval of cemiplimab in non–small cell lung cancer was supported by results from the phase 3 EMPOWER-Lung 1 trial that investigated its use as monotherapy in the first-line setting compared with platinum-doublet chemotherapy in patients with locally advanced or metastatic disease whose tumor cells expressed PD-L1.
Adjuvant Pazopanib Does Not Improve Overall Survival for Patients With Locally Advanced RCC
February 22nd 2021Follow-up data published in the European Association of Urology did not find a significant improvement in overall survival for patients with locally advanced renal cell carcinoma undergoing adjuvant pazopanib treatment.
Study Results Appear to Support Larotrectinib Use in NTRK+ Lung Cancer
February 20th 2021Patients with advanced lung cancer whose tumors harbor an NTRK gene fusion with or without central nervous system metastases were found to have high response rates, durable responses, and extended survival benefit with larotrectinib.
In B-Cell NHL, Off-the-Shelf NK Immunotherapy Shows Promise When Used With Chemotherapy and ASCT
February 19th 2021Findings presented at the 2021 Transplant & Cellular Therapy Meetings indicate that patients with B-cell non-Hodgkin lymphoma may benefit from a type of natural killer immunotherapy added to chemotherapy and transplant.
Timothy A. Yap, MBBS, PhD, FRCP, on COVID-19 Vaccination for Patients in Phase 1 Cancer Trials
February 19th 2021The medical oncologist and physician scientist based at the University of Texas MD Anderson Cancer Center explained recommendations for SARS-CoV-2 vaccination in patients participating in phase 1 oncology clinical trials.
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.