The Saudi Food and Drug Authority (SFDA) has granted Breakthrough Designation to Itovebi (Inavolisib( developed by Roche. The investigational therapy is intended for use in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or after completing adjuvant endocrine therapy.

Composition and Mechanism of Action
Itovebi contains the active substance Inavolisib, a selective PI3K inhibitor that primarily targets the PI3Kα isoform, which is frequently mutated in breast cancer. Studies have shown that combining Inavolisib with palbociclib and fulvestrant leads to enhanced tumor growth inhibition compared to using either treatment alone or in combination.

Clinical Evidence Supporting the Designation

The breakthrough designation of Inavolisib was based on compelling results from the Phase III INAVO120 clinical trial, which demonstrated that adding Inavolisib to the standard regimen of palbociclib and fulvestrant more than doubled progression-free survival (PSF) in the target population. This significant clinical benefit reflects the potential of Inavolisib to address an unmet medical need in patients with limited treatment options.

Regulatory Status and Implications

The SFDA emphasizes that this designation allows Inavolisib to be submitted and reviewed under the Breakthrough Track, subject to specific regulatory controls and mechanisms. This designation does not constitute a marketing authorization of the drug in Saudi Arabia. A final decision regarding registration will be announced following a full technical and scientific evaluation of the complete registration dossier.

The SFDA Breakthrough Medicine Program Expedites Access to Targeted Treatments

The Program aims to expedite access to innovative and effective treatments for serious diseases where existing therapies may be inadequate. To qualify for this designation, a drug must have completed clinical trials demonstrating promising efficacy and safety, offer a significant therapeutic advantage over current options, target serious or life-threatening conditions, and exhibit a positive benefit-risk balance. Notably, the product should not be registered with any other regulatory authority at the time of application.

For further information about the Breakthrough Medicines Program, please refer to the guide available on the SFDA website: https://sfda.gov.sa/en/regulations/89310 or contact the SFDA via email at Designation.Drug@sfda.gov.sa.