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).
News, Oncology
The FDA has been granted to Pemfexy™ (pemetrexed for injection; Eagle Pharmaceuticals), an alternative to Alimta® (Eli Lilly), for the treatment of non-small cell lung cancer (NSCLC) and malignant pleural mesothelioma.
Drugs in the Pipeline
In March 2016, tesevatinib was designated Orphan Drug status for the treatment of autosomal recessive polycystic kidney disease (ARPKD).
News
Pembrolizumab (Keytruda; Merck) has been approved by the Food and Drug Administration (FDA) to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test.
News
For patients with EGFR mutation-positive non-small cell lung cancer (NSCLC) being treated with afatinib, dosing may be reduced to decrease adverse events without any compromise in the treatment's efficacy. These are the findings of two new large Phase 3 trials.
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.
News
The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Gilotrif (afatinib; Boehringer Ingelheim).
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)
News
The approval was based on evidence from animal study data, human pharmacokinetic and pharmacodynamics data, and clinical immunogenicity data which demonstrated Mvasi is a biosimilar to Avastin.
