Roche wins EU endorsement for metastatic breast cancer treatment

Roche (OTCQX:RHHBY) (OTCQX:RHHBF) said that an advisory panel of the European Medicines Agency (EMA), endorsed its Itovebi combination for metastatic breast cancer treatment.

Issuing a so-called positive opinion, EMA’s Committee for Medicinal Products for Human Use (OTC:CHMP) has recommended the marketing authorization for Itovebi, in combination with palbociclib and fulvestrant, for adults with PIK3CA-mutated, ER-positive, HER2-negative advanced breast cancer that returned during or within a year after adjuvant hormone therapy.

The CHMP recommendation will next be reviewed by the European Commission (EC) before a final decision on marketing authorization, which is expected in the near future.