Swiss healthcare company Roche (RHHBY) on Friday said that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for its medicine Itovebi, in combination with Palbociclib and Fulvestrant, for the treatment of adult patients with an aggressive type of breast cancer.
The company said that a decision regarding the approval for the treatment is expected from the European Commission in the "near future."
CHMP’s opinion is based on results from one of the company’s late-stage study, which showed a 57% reduction in the risk of disease worsening or death with the Itovebi-based regimen compared with Palbociclib and Fulvestrant alone in patients whose breast cancer showed the presence of a PIK3CA mutation.
A PIK3CA mutation can make the disease more aggressive and worsen survival outcomes, the company said.
The Itovebi-based regimen is already approved for the treatment of adults with the form of cancer in the U.S.
Separately, Genentech, a wholly owned member of the Roche Group, on Thursday announced two-year follow-up data from its late-stage study.
The data continued to demonstrate improvement in overall survival for lymphoma patients treated with its bispecific antibody, Columvi, in combination with Gemcitabine and Oxaliplatin.
Eighty-nine percent of patients whose cancer had fully responded at the end of treatment with Columvi in combination with chemotherapy were still alive, and 82% showed no signs of cancer one year post-treatment, the company said.
On Stocktwits, retail sentiment around RHHBY has been ‘neutral’ over the past 24 hours, coupled with ‘normal’ message volume.
RHHBY stock is up by over 13% this year and about 25% over the past 12 months.
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