¡New FDA approval for breast cancer treatment!
Inavolisib
New possibility in cancer that progresses despite treatment
October 14 2024
In the second week of October 2024, Genentech, part of the Roche group, announced the approval by FDA of Inavolisib, in combination with palbociclib and fulvestrant, to treat adults with locally advanced or metastatic, hormone-refractory, mutation-positive breast cancer PIK3CA.
This oral treatment is indicated for patients who have experienced recurrence after completing adjuvant endocrine therapy. The mutation PIK3CA it is found in approximately 40% of HR-positive metastatic breast cancers. The inavolisib-based combination received Priority Review and Breakthrough Therapy designation from the FDA in Mayo 2024, based on the results of the study INAVO120.
About the INAVO120 study
The study INAVO120 [NCT04191499] it is a phase III, randomized, double-blind, placebo-controlled study that evaluates the efficacy and safety of Inavolisib in combination with palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant in people with HR-positive, HER2-negative, PIK3CA-mutated, locally advanced or metastatic breast cancer whose disease has progressed on or within 12 months of completion of adjuvant endocrine therapy (after surgery) and who have not received prior systemic therapy for metastatic disease
EHR-positive breast cancer, which accounts for about 70% of all cases, it is characterized by tumor cells that have receptors that attach to one or both hormones (estrogen or progesterone), which can drive tumor growth.
These patients face risks of disease progression and treatment side effects, creating a need for new therapeutic options. The PI3K signaling pathway is commonly deregulated in this type of cancer, frequently due to PIK3CA mutations, a mechanism that can cause resistance to standard endocrine therapy combined with cyclin-dependent kinase 4/6 inhibitors.