FDA approves Roche's new treatment for subset of breast cancer patients

The FDA has approved Roche’s inavolisib plus Pfizer’s Ibrance and fulvestrant in a subtype of breast cancer over a month before the target action date, the agency announced Thursday.

The treatment, which will be marketed as Itovebi, is now approved for adults with endocrine-resistant, locally advanced or metastatic, PIK3CA-mutated HR-positive HER2-negative breast cancer when used in combination with the other therapies. The approval is based on data from the INAVO120 trial, which showed that progression-free survival was 15 months in the combo arm compared to 7.3 months in the arm that combined a placebo with palbociclib and fulvestrant.

The trial also assessed overall response rate, which was 58% in the treatment arm and 25% in the placebo combo arm.

The PIK3CA mutation is found in about 40% of HR-positive breast cancers, and it’s linked to tumor growth, disease progression and treatment resistance, according to Roche, which noted in its own statement that Itovebi is the first targeted therapy approved for people with HR-positive disease. It expects that Itovebi will be available in the US “in the coming weeks.”

Levi Garraway

Levi Garraway, Genentech’s CMO and head of global product development, described the approval as “an important new first-line option” for this group of patients.

Back in December, Roche touted full data for its treatment, saying then it hoped that inavolisib would be the first drug approved as a first-line treatment in the disease. During the company’s pharma day in London in September, Roche Pharmaceuticals CEO Teresa Graham said the company expects inavolisib to bring in between CHF 2 billion ($2.37 billion) and CHF 3 billion ($3.55 billion) in peak sales.

Charlie Fuchs

Charlie Fuchs, head of product development in oncology at Genentech and Roche, told Endpoints News that the treatment has a “really convincing benefit” of a 57% reduction in the risk of disease progression or death in the first-line setting.

“What this conveys is a reasonably tolerable and effective therapy that can change the natural history,” Fuchs said.

The company has said that data from the trial are also being used for regulatory submissions to other regulators, including the European Medicines Agency.