FX.co ★ Roche, Genentech: Inavolisib Gets FDA Breakthrough Status To Treat Breast Cancer With Mutation

Roche Holding AG (RHHBY) and its U.S. subsidiary, Genentech, announced on Tuesday that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for inavolisib. This designation pertains to the treatment of advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation.

Inavolisib, an investigational oral therapy, has received this designation to be used in combination with palbociclib (Ibrance) and fulvestrant. The treatment is intended for adult patients with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer, especially for those who have experienced recurrence within 12 months of completing adjuvant endocrine therapy.

The Breakthrough Therapy Designation is based on results from the Phase III INAVO120 study, which demonstrated that an inavolisib-based regimen more than doubled progression-free survival compared to the combination of palbociclib and fulvestrant alone in the first-line setting.

According to the companies, approximately 40 percent of individuals with hormone receptor-positive breast cancer have a PIK3CA mutation, which often correlates with a poorer prognosis and resistance to endocrine treatment.

At this stage, overall survival (OS) data remains immature, but a clear positive trend has been observed. The follow-up for OS data will continue through the next analysis phase.

The FDA awards Breakthrough Therapy Designation to expedite the development and review of drugs that are intended to treat serious or life-threatening conditions and for which preliminary clinical evidence suggests a substantial improvement over existing therapies.

Roche's oncology portfolio has received a total of 29 Breakthrough Therapy Designations, including this latest one.

Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development, remarked, "We are pleased that the FDA has granted Breakthrough Therapy Designation for inavolisib, recognizing the significant clinical benefits observed with this regimen. This promising inavolisib-based treatment could revolutionize the PI3K inhibitor class, potentially setting a new standard of care for this patient population in the first-line setting."

The company also plans to submit the data from the INAVO120 study to other global health authorities, including the European Medicines Agency.

Inavolisib is being examined in three company-sponsored Phase III clinical studies (INAVO120, INAVO121, INAVO122) for PIK3CA-mutated locally advanced or metastatic breast cancer in various combinations.

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