Introduction to the new drug Inavolisib developed by Roche
Inavolisib (Inavolisib) is a highly selective PI3Kα inhibitor developed by Roche, which represents an important progress in the field of precision treatment of breast cancer. The drug mainly targetsPIK3CA mutations, a common driving factor in hormone receptor-positive, HER2-negative breast cancer, and intervenes in tumor cell proliferation and drug resistance formation from the source by precisely inhibiting the abnormally activated PI3K signaling pathway.
In clinical application, inaliset is not used as a single drug, but in combination with palbociclib (Palbociclib) and fulvestrant (Fulvestrant) to form a systemic treatment plan. This combined strategy fully embodies the therapeutic concept of "multi-target synergistic inhibition", which on the one hand blocks the progression of the tumor cell cycle and on the other hand reverses the endocrine resistance mechanism, thereby delaying disease progression.

Inalise is mainly suitable for patients with PIK3CA mutated breast cancer who have progressed or relapsed after endocrine therapy. Studies have shown that compared with early PI3K inhibitors, inaliset maintains anti-tumor activity while having a relatively more controllable impact on normal tissues, improving treatment tolerance. This feature also makes it more practical when combined with CDK4/6 inhibitors and endocrine therapy.
From the perspective of drug research and development, the emergence of inalise marks the transition from "broad-spectrum inhibition" to "precise regulation" of PI3K targeted therapy Its high selectivity helps reduce unwanted signaling pathway interference, thereby increasing the therapeutic window. This is also an important part of Roche’s layout for precision treatment of breast cancer.
In clinical practice, whether to use inalised usually needs to be based on clear PIK3CA mutation detection results. With the popularization of molecular testing technology, more and more patients can be matched to appropriate targeted solutions through accurate typing. For patients with endocrine-resistant HR-positive breast cancer, the combination regimen of inaliset provides new possibilities for long-term disease control.
Reference materials:https://www.itovebi-hcp.com/
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