July CHMP recommendations: Data Byte

Among CHMP’s positive opinions this month is a recommendation for Nexviadyme avalglucosidase alfa, a long-term recombinant human GAA replacement therapy by the Genzyme unit of Sanofi (Euronext:SAN; NASDAQ:SNY), to treat Pompe disease.

Meanwhile, Roche (SIX:ROG; OTCQX:RHHBY) withdrew its application for Tecentriq atezolizumab to treat early or locally advanced triple-negative breast cancer (TNBC). In a letter to EMA, the company cited lack of evidence from the Phase III IMpassion031 study that the PD-L1 inhibitor led to a positive benefit-risk balance for the indication. In April, FDA’s ODAC voted to retain the accelerated approval for Tecentriq to treat TNBC due to a lack of alternatives...