The Saudi Food and Drug Authority (SFDA) has granted Breakthrough Designation to Eli Lilly’s medication, Imlunestrant (Inluriyo), for the treatment of advanced breast cancer. Imlunestrant is being developed as a monotherapy for the treatment of adult patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer who have previously been treated with an endocrine based regimen.

Imlunestrant: A Selective Estrogen Receptor Inhibitor

The product contains the active ingredient Imlunestrant, which is designed to

antagonize and degrade both-wild type and mutant ERα, leading to inhibition of estrogen receptor-dependent gene transcription and cellular proliferation in ER+ breast cancer cells. This novel mechanism may help overcome endocrine resistance commonly seen in ESR1-mutant tumors.

Clinical Study: It Targets Serious and Life-Threatening disease

The designation was granted based on clinical data from a global clinical trial, which demonstrated that Imlunestrant showed an improvement in progression-free survival compared to standard treatment in the target population. These findings suggests a potentially favorable benefit-risk profile, particularly for patients with limited therapeutic options. The Breakthrough Designation is granted for treatments that show early evidence of substantial improvement over existing therapies for serious or life-threatening conditions.

Registration is Subjected to Full Scientific Evaluation

The SFDA emphasizes that this designation allows Inluriyo 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

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