Top-line analysis showed a highly statistically significant and clinically meaningful improvement in overall survival for CC-486
Celgene plans regulatory submissions beginning in 1H 2020
SUMMIT, N.J.–(BUSINESS WIRE)– Celgene Corporation (NASDAQ: CELG) today announced top-line results from the international phase 3, randomized, double-blind, placebo-controlled study, QUAZAR AML-001. The study evaluated the efficacy and safety of investigational therapy CC-486 as maintenance therapy in patients with newly diagnosed acute myeloid leukemia (AML) who achieved first complete response (CR) or complete response with incomplete blood count recovery (CRi) with induction chemotherapy (with or without consolidation). The study demonstrated that maintenance treatment with CC-486 resulted in a highly statistically significant and clinically meaningful improvement in overall survival compared to placebo. The key secondary endpoint of relapse-free survival (RFS) also showed a statistically significant improvement. Read the full press release HERE.
The FDA recently approved Inrebic® (Fedretinib) for Myelofibrosis, the first new treatment in decades. Available as a once-daily oral dose, this is a new option for patients. Learn more: https://ir.celgene.com/press-releases/press-release-details/2019/US-FDA-Approves-INREBIC-Fedratinib-as-First-New-Treatment-in-Nearly-a-Decade-for-Patients-With-Myelofibrosis/default.aspx
JOHNS CREEK, Ga.
The Pharmacy Anti-Steering and Transparency Act, which will go into effect Jan. 1, 2020, prohibits insurers and benefits managers who have ownership in a pharmacy from steering patients to that business. The law endeavors to reduce conflicts of interests, increase transparency and give patients more choice.
The law was inspired in part by local pharmacist Jennifer Shannon, who saw first-hand how coercive steering practices can negatively impact patient care.
A recently published Phase III Trial by Athenex, Inc. showed that oral paclitaxel in combination with encequidar was superior to IV paclitaxel for Overall Response Rate in Metastatic Breast Cancer. Patients in the oral combination group also had less incidence of neuropathy than the intravenous group.