The Menarini Group has signed an exclusive sub-licensing agreement with SciClone Pharmaceuticals for the development and commercialisation of Orserdu (elacestrant) to treat patients with advanced or metastatic breast cancer (mBC) in China.

SciClone will undertake the development and registration of Orserdu in China, followed by its market launch upon regulatory clearance in the country.

SciClone executive director, president and CEO Zhao Hong stated: “We believe that this agreement will enable us to work toward providing oncologists with an important option [to treat] their ER+, HER2- mBC patients whose tumours have an ESR1mutation.”

In January 2023, the US Food and Drug Administration granted approval under priority review and fast track designation to Orserdu for treating advanced or mBC in postmenopausal women or adult men with ER+, HER2-, ESR1-mutated and progressive disease after at least one line of treatment.

In September 2023, this once-daily oral endocrine monotherapy received approval from the European Commission.

Menarini’s wholly owned subsidiary Stemline Therapeutics is responsible for commercialising Orserdu in the US and the European Union (EU).

The approval of Orserdu in the US and the EU is backed by data from the Phase III EMERALD trial, which showed a statistically significant improvement in progression-free survival (PFS) with elacestrant compared with the standard-of-care.

This randomised, open-label, active-controlled trial is designed for assessing elacestrant as second or third-line monotherapy in ER+, HER2-advanced or mBC patients.

Its primary endpoints were PFS in the overall patient population and patients with ESR1 mutations.

The trial enrolled 478 patients who had received earlier treatment with one or two lines of endocrine therapy, including a CDK4/6 inhibitor.

Menarini Group CEO Elcin Barker Ergun stated: “We are proud to partner with SciClone in an effort to register a new breast cancer treatment for patients in China that can offer efficacy in a once-daily pill.”