Novartis announced on Tuesday that it has received approval from the Egyptian Drug Authority (EDA) for a new indication for Kisqali as an adjuvant treatment for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor-2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence.
The cyclin-dependent kinase inhibitor (CDKi) is indicated for use in combination with an aromatase inhibitor. According to WHO Globocan 2024 data cited in the release, breast cancer accounts for approximately 37% of all female cancer cases in Egypt and is a leading cause of cancer mortality among Egyptian women.
“This approval reflects our commitment to reimagining cancer care in Egypt by bringing innovation earlier in the treatment journey, while continuing to work alongside clinicians, health authorities and patient communities to improve outcomes for eligible patients,” said Jihane El Murr, Country President of Novartis Egypt.
HR+/HER2− represents the most common breast cancer subtype globally. Reports from 2022 indicate Egypt has one of the highest incidence rates in the World Health Organization Eastern Mediterranean Region, at 55.4 cases per 100,000 women. Studies show that 57% of Egyptian breast cancer patients are premenopausal, with a mean age at diagnosis of 50.5 years.
Novartis stated it is coordinating with relevant authorities to facilitate access for eligible patients through regulatory and healthcare system channels, while supporting medical professionals with educational initiatives to optimise treatment adherence.
The approval aligns with Egypt Vision 2030 priorities and national efforts to enhance oncology care. These efforts complement the government’s Presidential Initiative for Women’s Health, which has provided screening and awareness services to over 70 million women since 2019, registering more than 35,390 breast cancer cases.
Under a Memorandum of Understanding signed with the Egyptian Healthcare Authority in 2025, Novartis Egypt agreed to enhance physician capabilities, align diagnostic and treatment mechanisms with international standards, and develop an online platform for doctors to coordinate breast cancer treatment plans. Novartis also sponsored the “Hekaya Wardy” awareness campaign to promote early detection and address cultural taboos surrounding the disease.
