The first and only targeted medicine for HR+/HER2- advanced breast cancer with a PIK3CA mutation available now for patients in Slovenia

  • Alpelisib is the  only treatment approved specifically to address PIK3CA mutation, underscoring  Novartis commitment to reimagining cancer care.
  • Every year around  3501people in Slovenia and 334,000 worldwide are diagnosed with  advanced breast cancer, and approximately 40% of those with HR+/HER2- subtype  have a PIK3CA mutation, which is associated with a poor prognosis2-11.  
  • We produce the drug  substance for this important medicine in Novartis Technical operations in  Mengeš.
4. 6. 2021

Novartis today announced that alpelisib, which is used in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy is now available for patients in Slovenia. Alpelisib is the first and only treatment specifically approved for people with advanced breast cancer whose tumors harbor a PIK3CA mutation, which stimulates tumor growth and is associated with poor response to therapy12.

“Alpelisib is an important new therapy for HR+/HER2- advanced breast cancer patients whose tumors have a PIK3CA mutation, and we look forward to making it available for patients in Slovenia,” said Predrag Bogavac, Head Novartis Oncology in Slovenia. “Knowledge of PIK3CA status can better equip doctors as they develop a personalized upfront treatment plan for patients. Alpelisib offers new hope for advanced breast cancer patients with a PIK3CA mutation, who typically face a worse overall prognosis.”

What is a mutation? Mutations are like typos in our DNA. What are the types of mutation? We know sporadic mutations – they occur at random and are not passed down form parent to child. PIK3CA is a sporadic mutation. We also know inherited mutations – they are passed down from parent to child.BRCA1/2 is an inherited mutation.

Why is it important for patients to understand PIK3CA mutation? PIK3CA mutations have been linked to cancer growth. Just as tumor's HR and HER2 status, also the mutation status informs doctor whether certain proteins fuel growth of cancer. Tumor's mutation status may affect how the doctor manages patient's cancer care.

Patients with HR+/HER2- advanced breast cancer should be selected for treatment with alpelisib based on the presence of a PIK3CA mutation in tumor or plasma specimens, using a validated test. If a mutation is not detected in a plasma specimen, tumor tissue should be tested if available.

European Commission (EC) has approved alpelisib in July 2020. This approval has followed a positive opinion granted in May 2020 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

In Slovenia, we can be proud, as we produce the drug substance for this important medicine in Novartis Technical operations in Mengeš. Thus, Slovenian knowledge contributes to the modern treatment of patients with breast cancer.


  1. Europa Donna Slovenija: Zdravljenje raka dojk. Available at: Razsejani  rak dojk | Europa Donna Slovenija (Retrieved: May 2021).
  2. Globocan 2018 (WHO), Cancer Today: Estimated number of new cases in 2018, worldwide, females, all ages_1_ 2018.
  3. Gheorghe D. Breast Cancer. Decision Resources. July 2017:1-338.
  4. Tolaney S, Toi M, Neven P, et al. Presented at: 2019 American Association for Cancer Research (AACR) Annual Meeting; March 29-April 3, 2019; Atlanta, GA.
  5. Di Leo A, Johnston S, Seok Lee K, et al. Lancet Oncol. 2018;19(1):87-100.
  6. Moynahan ME, Chen D, He W, et al. Br J Cancer. 2017;116(6):726-730002E
  7. The Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012;490(7418):61-70.
  8. Sobhani N, Roviello G, Corona SP et al. The prognostic value of PI3K mutational status in breast cancer: a meta-analysis. J Cell Biochem. 2018;119(6):4287-4292.
  9. Sabine V, Crozier C, Brookes C, et al. Mutational analysis of PI3K/AKT signaling pathway in tamoxifen exemestane adjuvant multinational pathology study. Journal of Clinical Oncology. 2014;32:2951-2958.
  10. Miller TW, Rexer BN, Garrett JT, et al. Mutations in the Phosphatidylinositol 3-Kinase Pathway: Role in Tumor Progression and Therapeutic Implications in Breast Cancer. Breast Cancer Res. 2011.
  11. Saal LH, Johansson P, Holm K. Poor prognosis in carcinoma is associated with a gene expression signature of aberrant PTEN tumor suppressor pathway activity. PNAS. 2007;104(18):7564-7569.
  12. Thomssen, C., et al. (2020, February 10). International Consensus Conference for Advanced Breast Cancer, Lisbon 2019: ABC5 Consensus – Assessment by a German Group of Experts. Retrieved June 16, 2020, from
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Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Novartis is the leading provider of medicines in Slovenia, operating through Novartis Pharma Services Inc., Podružnica v Sloveniji, Lek and Sandoz. Find out more at

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This press release contains statements and conclusions based on projections of the future business operations. These estimates are derived from the best information currently available. In case these forecasts prove unreliable, the actual results could prove different from those projected.

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For more information please contact:
Katarina  Klemenc
Head Communications and Patient Engagement
Phone: +386 1 580 22 43

Material prepared: May 2021