We went through our analytics: here is what your colleagues in oncology read in 2019.
As I look through just-published tables of age-adjusted cancer mortality, I recognize an unprecedented development:
The ink hadn't dried on the headline of the lead story in the Dec. 29 issue of The New York Times when on Jan. 2 HHS Secretary Alex Azar and newly arrived FDA Commissioner Stephen M. Hahn made the following announcement:
FDA issued a draft guidance document, “FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act.”
FDA approved Avsola (infliximab-axxq) for all approved indications of the reference product, Remicade (infliximab), including treatment of moderate-to-severe rheumatoid arthritis, moderate-to-severe Crohn's Disease in the adult and pediatric population, moderate-to-severe ulcerative colitis in the adult and pediatric population, chronic severe plaque psoriasis, psoriatic arthritis and ankylosing spondylitis.
FDA granted Breakthrough Therapy Designation for the Janssen Pharmaceutical Companies of Johnson & Johnson's JNJ-68284528 (JNJ-4528), an investigational B cell maturation antigen-directed chimeric antigen receptor T-cell therapy in previously treated patients with multiple myeloma.
A new analysis shows that a donor stem cell transplant following treatment with an immune checkpoint inhibitor is generally safe and produces good outcomes for patients with Hodgkin lymphoma, easing concerns that these patients are at heightened risk for severe immune-related complications.
Bristol-Myers Squibb Co. said the pivotal study of lisocabtagene maraleucel (liso-cel) an investigational CD19-directed CAR T-cell therapy with a defined composition of purified CD8+ and CD4+ CAR T cells in relapsed/refractory large B-cell lymphomas (TRANSCEND NHL 001) met its primary and secondary endpoints while demonstrating durable responses.
Phase II KarMMa study of ide-cel in relapsed, refractory multiple myeloma meets ORR primary endpoint
Results from the KarMMa study, a pivotal, open-label, single arm, multicenter, phase II study of idecabtagene vicleucel met its primary endpoint of overall response rate in the treatment of relapsed and refractory multiple myeloma.
Seattle Genetics Inc. announced positive pivotal data from the HER2CLIMB trial evaluating tucatinib in patients with HER2-positive metastatic breast cancer.
