FDA panel to discuss pediatric cancer products

FDA's pediatric oncology subcommittee will meet on Nov. 5 to discuss pediatric development plans for three cancer compounds. The products to be discussed are nivolumab ( BMS-936558) from Bristol-Myers Squibb Co. (NYSE:BMY); MK-3475 from Merck & Co. Inc. (NYSE:MRK); and LEE011 from Novartis AG (NYSE:NVS; SIX:NOVN).

Nivolumab, a human IgG4 mAb against programmed cell death 1 ( PDCD1; PD-1; CD279), is in Phase III testing for non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC) and advanced melanoma. MK-3475 is a humanized IgG4 mAb against PD-1 in Phase II/III testing for NSCLC and Phase III testing for melanoma. LEE011 is a cyclin dependent kinase 4 (CDK4) and CDK6 inhibitor in Phase I testing to treat solid tumors. ...