Roche, Genentech: Inabolisib receives FDA breakthrough status for treatment of mutated breast cancer

(RTTNews) – Swiss pharmaceutical giant Roche Holding (RHHBY) and its U.S. arm Genentech announced on Tuesday that the U.S. Food and Drug Administration has granted breakthrough therapy to Inavoliv to treat advanced hormone receptor-positive, HER2-negative breast cancer with PIK3CA. It was announced that it had been granted drug designation. mutation.

This designation is given to inavolisib, an investigational oral treatment in combination with palbociclib (Ibrance) and fulvestrant. It is intended for treatment of adult patients with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer after recurrence and within 12 months of completion of adjuvant endocrine therapy .

This designation is based on results from Phase III INAVO120, which showed that inavolisib-based regimens more than doubled progression-free survival compared to palbociclib and fulvestrant alone in the first-line setting. Shown.

The companies noted that approximately 40% of HR-positive breast cancer patients have PIK3CA mutations and often face poor prognosis and resistance to endocrine therapy.

Although overall survival or overall survival data are immature at this time, clear positive trends are observed. OS follow-up continues in the next analysis.

FDA will conduct the development and regulatory review of medicines intended to treat serious or life-threatening conditions for which preliminary clinical evidence indicates that they may represent a significant improvement over existing treatments. To accelerate, issue Breakthrough Therapy designations.

Roche’s oncology portfolio has received 29 breakthrough therapy designations to date, including the most recent.

“The FDA has granted Breakthrough Therapy Designation to inavolib in recognition of the substantial clinical benefits observed with this regimen,” said Levi Garraway, Roche’s chief medical officer and head of global product development. “This promising inavoliv-based regimen has the potential to transform society.” PI3K inhibitor class and has the potential to become the standard of care for this patient population in the first-line setting. ”

The company has also submitted INAVO120 data to other global health authorities, including the European Medicines Agency.

Inavolisib is currently being studied in various combinations in three company-sponsored phase III clinical studies (INAVO120, INAVO121, INAVO122) in locally advanced or metastatic breast cancer with PIK3CA mutations.

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