Ocrelizumab/Hyaluronidase-ocsq

Roche’s PI3K inhibitor Itovebi (inavolisib) has been approved by the US Food and Drug Administration (FDA) as part of a combination treatment for advanced breast cancer. The drug has been authorised for use alongside Pfizer’s CDK4/6 inhibitor Ibrance (palbociclib) and fulvestrant hormone therapy to treat adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer. The FDA’s decision was supported by positive results from the late-stage INAVO120 study, in which the Itovebi-based regimen reduced the risk of disease worsening or death by 57% compared with Ibrance and fulvestrant alone in the first-line setting. Overall survival (OS) data was immature at the time of primary analysis, but a “clear positive trend” was observed with the triplet therapy, Roche said, adding that OS will continue to be assessed. Approximately 310,720 women are expected to be diagnosed with invasive breast cancer in the US this year. HR-positive breast cancer is the most common subtype of the disease and PIK3CA mutations, which have been linked to tumour growth, disease progression and treatment resistance, are found in approximately 40% of HR-positive metastatic breast cancers. Roche said that Itovebi will be available in the US in the coming weeks, adding that results from INAVO120 are also being submitted to other global health authorities, including the European Medicines Agency. The company’s chief medical officer and head of global product development, Levi Garraway, said: “With the approval of this Itovebi-based regimen, we continue our long-standing track record of cancer therapeutic discovery by offering an important new first-line option for people living with HR-positive breast cancer with a PIK3CA mutation. “Despite the high prevalence of PIK3CA mutations in this setting, treatment options have thus far remained limited, which makes [this] approval all the more significant.” The authorisation comes less than a month after the FDA approved Roche’s injectable monoclonal antibody Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) to treat both relapsing and primary progressive multiple sclerosis. The company was also recently granted breakthrough device designation by the US regulator for its Alzheimer’s disease blood test Elecsys pTau217, which is being developed in collaboration with Eli Lilly.