Trials show that, children and young adults with relapsed or refractory B-cell acute lymphoblastic leukemia reported sustained, clinically meaningful improvement in quality-of-life scores after receiving chimeric antigen receptor T-cell therapy. To know more such updates, join us at: http://tiny.cc/9t8ybz
Friday, December 6, 2019
Friday, November 22, 2019
FDA has approved acalabrutinib for adults with chroniclymphocytic leukemia or small lymphocytic lymphoma as an initial or subsequent therapy. This would mark the second approval under Project Orbis.
FDA used the Real-Time Oncology Review pilot program in its review of the application for acalabrutinib, a process to streamline the submission of data before the completion of the entire drug application “Today, as part of a U.S., Australian and Canadian collaboration known as Project Orbis, the U.S. approved a new treatment option for those living with chronic lymphocytic leukemia or small lymphocytic lymphoma. The FDA’s Project Orbis provides a framework for concurrent submission and review of oncology drug applications among the FDA’s international partners,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in a press release.
The FDA based this supplemental approval of acalabrutinib on data from two randomized studies.
The first trial, which included 535 patients with previously untreated CLL- showed longer PFS among patients assigned acalabrutinib compared with other standard treatments.
The second trial of 310 patients with CLL also showed longer PFS with acalabrutinib vs. other standard treatments.
Common adverse events associated with acalabrutinib included anemia, neutropenia, upper respiratory tract infection, thrombocytopenia headache, diarrhea and musculoskeletal pain.
Source: Healio hemonc today
Sunday, October 27, 2019
FDA approved rivaroxaban for the prevention of venous thromboembolism in hospitalized, acutely ill patients at risk for thromboembolic complications who do not have high bleeding risk. Explore more such facts in: http://tiny.cc/9t8ybz
Saturday, October 5, 2019
FDA grants duvelisib orphan drug designation for the treatment of T-cell lymphoma. Know more oncology at: https://hematology.cmesociety.com/
Saturday, September 28, 2019
According to study, four months of induction combination chemotherapy followed by surgical exploration made secondary resection feasible for patients with nonresectable locally advanced pancreatic cancer. Know more oncology at: https://hematology.cmesociety.com/
Saturday, September 7, 2019
The FDA has given orphan drug status to CT053, an investigational chimeric antigen receptor T-cell therapy for the treatment of multiple myeloma.
CT053 (CARsgen Therapeutics) is an autologous, fully human CAR T-cell therapy that targets the B-cell maturation antigen on the surface of cancer cells.
CARsgen’s CT053 is one of the company’s three CAR T-cell products approved for early-stage clinical trials. The others include humanized CD19 CAR-T for B-cell leukemia and lymphoma and GPC3 CAR-T for hepatocellular carcinoma and non-small cell lung cancer.
“FDA orphan designation is an important regulatory milestone in the continued development and commercialization of CT053 anti-BCMA CAR-T cells,” Zonghai Li, MD, PhD, founder, CEO and chief scientific officer of CARsgen said in a press release.
Li added that CT053 showed “outstanding potency” during an exploratory phase 1 clinical study in China, where 19 of 24 patients with relapsed or refractory multiple myeloma had a complete response to therapy. In addition, there were no cases of high-grade (3 or 4) cytokine release syndrome during the study.
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.
Tuesday, August 27, 2019
Trials show that adding pembrolizumab to standard therapy failed to improve clinical outcomes for untreated or relapsed/refractory multiple myeloma. Explore more hemato-oncology at: http://bit.ly/2xaW3zT