News
Durvalumab approved for advanced urothelial carcinoma
The Food and Drug Administration has granted accelerated approval to the checkpoint inhibitor durvalumab for patients with locally advanced or...
News
FDA approves brigatinib for second-line advanced ALK-positive NSCLC
Approval was based on a meaningful and durable overall response rate in a two-arm, open-label, multicenter trial of 222 patients.
News
Osimertinib receives full approval for advanced EGFR-mutated NSCLC
There is a new treatment available for patients who have metastatic epidermal growth factor receptor T790M mutation–positive non–small cell lung...
News
PARP inhibitor approved as maintenance for recurrent ovarian cancer
The indication does not require a suspected or confirmed deleterious BRCA mutation.
News
FDA approves first treatment for metastatic Merkel cell carcinoma
A newly approved drug may help the body’s immune system attack metastatic MCC cells.
News
FDA approves ribociclib for HR+, HER2– advanced breast cancer
The Food and Drug Administration has approved ribociclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, in combination with an aromatase...
News
FDA approves nivolumab for advanced urothelial carcinoma
The recommended dose for advanced urothelial carcinoma is 240 mg intravenously every 2 weeks.
Article
FDA approves rucaparib for BRCA-positive advanced ovarian cancer
Approval of rucaparib (Rubraca), a PARP inhibitor, was based on an objective response rate of 54%, and a median duration of response of 9.2 months...
Article
FDA affirms bladder cancer warning with diabetes drug
The FDA reaffirmed its warning on the possible risk of bladder cancer associated with use of the type 2 diabetes drug pioglitazone.
Article
FDA approves nivolumab for advanced squamous cell carcinoma of the head and neck
The agency based its approval on an improvement in overall survival shown in the CheckMate-141 trial, which compared nivolumab with the...
Article
FDA expands indication for pembrolizumab in NSCLC
Pembrolizumab (Keytruda) is now approved to treat patients with metastatic NSCLC whose tumors have high PD-L1 expression, with no EGFR or ALK...
Article
FDA approves atezolizumab for advanced NSCLC
The FDA has approved the PD-L1 blocking antibody atezolizumab for the treatment of patients with metastatic non–small-cell lung cancer whose...
Article
FDA grants accelerated approval to olaratumab for soft tissue sarcoma
Olaratumab, a platelet-derived growth factor receptor-alpha blocking antibody, is the first new therapy approved in 40 years for the initial...
