Drugs in the Pipeline
AbbVie announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation to veliparib, an investigational combination with chemotherapies or radiation for the treatment of advanced squamous non-small cell lung cancer (NSCLC).
Drugs in the Pipeline
In March 2016, tesevatinib was designated Orphan Drug status for the treatment of autosomal recessive polycystic kidney disease (ARPKD).
Drugs in the Pipeline
Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Opdivo (nivolumab), to potentially treat recurrent or metastic squamous cell carcinoma of the head and neck (SCCHN) after platinum based therapy.
Drugs in the Pipeline
Pfizer has begun enrolling patients in a Phase 3 study of lorlatinib, called 'CROWN'. The trial will be an open-label randomized, two-arm study comparing lorlatinib to crizotinib in the first-line treatment of patients with metastatic ALK-positive NSCLC.
Drugs in the Pipeline
Genentech announced that the Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq (atezolizumab)
Drugs in the Pipeline
The sBLA is based on results from the Phase 2 KEYNOTE-224 trial, which enrolled 104 individuals with advanced hepatocellular carcinoma previously treated with sorafenib who were either intolerant to or showed progression of disease after treatment.
Drugs in the Pipeline
REACH-2 was a randomized, double-blind, placebo-controlled trial that enrolled 292 patients with hepatocellular carcinoma (HCC) who were intolerant to, or had disease progression while on or following treatment with sorafenib and had a high alpha-fetoprotein (AFP-High) defined as AFP ≥400ng/mL.
Drugs in the Pipeline
Dacomitinib is a pan-human epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor.
Drugs in the Pipeline
Enfortumab vedotin is an investigational ADC composed of an anti-Nectin-4 monoclonal antibody attached to monomethyl auristatin E, a microtubule-disrupting agent.