Ribociclib Receives Breakthrough Therapy Designation
The cyclin dependent kinase inhibitor received Breakthrough Therapy Designation as a first line treatment for advanced breast cancer.
Novartis’ cyclin dependent kinase (CDK4/6) inhibitor LEE011 (ribociclib) in combination with letrozole, received Breakthrough Therapy Designation from FDA as a first line treatment for hormone receptor positive, human epidermal growth factor receptor 2-negative advanced breast cancer (HR+/HER2-), the company said in an August 3, 2016 press announcement. This marks the company’s 11th Breakthrough Therapy Designation from FDA.
The Breakthrough Therapy designation is primarily based on results from a Phase III MONALEESA-2 trial in combination with letrozole. According to Novartis, Phase III trials met the primary endpoint for clinically meaningful improvement in progression free survival. If approved, the drug may be a direct competitor with Pfizer’s Ibrance (palbociclib), an oral inhibitor of cyclin-dependent kinases 4 and 6. In a Q2 earnings report, Pfizer noted Ibrance continued to perform strongly for the company.
Shilpa Medicare Launches ‘Hybrid CDMO’ at DCAT Week 2025
March 17th 2025This model is being positioned by Shilpa as a dual approach that offers comprehensive discovery, clinical, and commercial outsourcing services in addition to commercially ready, “off-the-shelf” novel formulations for b2b licensing.
