Drugs in the Pipeline
The NDA proposes the use of ready-to-dilute pemetrexed injection for the treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) and mesothelioma (in combination with cisplatin).
Drugs in the Pipeline
LOXO-292 is being evaluated in the ongoing Phase 1/2 LIBRETTO-001 clinical trial.
Drugs in the Pipeline
ARIAD announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for brigatinib to treat patients with metastatic ALK+ non-small cell lung cancer (NSCLC) who have progressed on crizotinib.
Drugs in the Pipeline
The sBLA submission was based on results from the Phase 1/2 CheckMate -040 study.
Drugs in the Pipeline
Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) for Priority Review.
Drugs in the Pipeline
Imfinzi, an anti-PD-L1 monoclonal antibody, was previously granted accelerated approval from the FDA for locally advanced or metastatic urothelial carcinoma in patients who have disease progression during or after platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
Drugs in the Pipeline
Merck announced that the Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab) for review.
