Bayer Advances PI3K Inhibitor for CancerBy
Bayer HealthCare has expanded its global clinical development program for the investigational oncology compound copanlisib, which now includes two new Phase III studies and one additional Phase II study exploring new treatment options for various subtypes of non-Hodgkin's lymphoma (NHL). Copanlisib is a novel intravenous pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor. The PI3K pathway is one of the most frequently altered pathways in cancer, and the PI3K isoforms regulate many cellular functions, such as growth control, metabolism and transcription initiation. Copanlisib is one of the company's key pipeline assets currently in clinical development.
Copanlisib was recently granted Orphan Drug Designation (ODD) by the US Food and Drug Administration’s Office of Orphan Products Development (OOPD) in the US for the treatment of follicular lymphoma (FL), a histologic subtype of NHL. The ODD program provides orphan status to drugs and biologics that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders. Orphan drugs are mainly drugs for rare diseases. The FDA regards any disease that affects less than 200,000 patients in the US as rare.
Source: Bayer HealthCare