Russia launches program to help breast cancer patients get innovative drug pyrotinib

Moscow, March 2025 — In March 2025, Russia initiated a program to assist medical oncology organizations in providing access to the tablet-based novel targeted therapy medication pyrotinib for previously treated patients with early, locally advanced, advanced or metastatic HER2-positive breast cancer (BC). The project created by Petrovax Pharm will allow patients who have no alternative options for effective therapy to receive free treatment with a unique cutting-edge product.

Breast cancer is the most common cancer in women^[1]. Despite the advances in modern medicine that have saved the lives of many patients with this diagnosis if detected in time, HER2-positive breast cancer remains one of the most prognostically unfavorable types of this cancer^[2]. Therefore, the society still urgently requires new therapeutic modalities.

Pyrotinib is a dual-acting oral tyrosine kinase inhibitor that has been shown in clinical trials^[3],[4], to increase significantly survival and disease control indicators in patients with various malignancies, particularly breast cancer. These results were achieved thanks to the unique features this drug possesses, which irreversibly binds to the EGFR (HER-1), HER2 and HER4 ErbB group receptors, resulting in the inhibition of tumor growth and angiogenesis.

Patients across Russia will be able to participate in the program if a case conference decides it to be appropriate. The project will continue until the product is officially authorized and available on the market, which is scheduled for mid-2026.

To enroll in the program, a patient requires a conclusion from a case conference of the Federal Oncology Center. The first step for patients is to contact an oncologist at their place of residence. The attending physician will decide whether the drug can be administered based on established medical criteria. The drug can be provided either through a federal oncology center or through a regional medical and preventive institution where the patient receives treatment.

The program is intended to help patients with advanced and/or metastatic HER2-positive breast cancer who have previously received therapy that included trastuzumab; early or locally advanced HER2-positive breast cancer after completion of adjuvant therapy with trastuzumab as monotherapy in an extended adjuvant regimen, who meet the requirements the program contains.