People with CML in El Salvador, Indonesia and the Philippines among the first to receive generic nilotinib via the ATOM Coalition

To date, an estimated 375 people with CML across El Salvador, Indonesia, and the Philippines have, or are currently being treated with, nilotinib. Nilotinib, is included on the World Health Organization’s Model List of Essential Medicines as a vital treatment for CML.

The progress on LMIC access to nilotinib began with the ATOM Coalition’s facilitation of an agreement in 2022 by Novartis, a founding partner of the Coalition, to grant a public health-oriented voluntary licence for nilotinib to the Medicines Patent Pool (MPP), also an ATOM Coalition partner. It was the first licence of its kind for a cancer medicine and has since enabled multiple generic manufacturers to supply quality-assured nilotinib for a range of LMICs.  

“Seeing these efforts result in broader medicines reach is a strong testament to how the power of collaboration and the Coalition can benefit patients across LMICs,” said Dr Lutz Hegemann, President of Global Health at Novartis.

The achievement of access to nilotinib also represents a turning point for patient advocacy organisations. “For over 25 years, we have championed access to CML therapy. The sale of SRA-approved generic nilotinib is a critical milestone but it cannot end there. We must keep treatment access at the center of every decision. It is imperative that we work collaboratively to ensure patients are receiving continued and affordable access to generic nilotinib in these three countries,” said Pat Garcia-Gonzalez, CEO of The Max Foundation.

For MPP, the milestone confirms the value of the Coalition in tackling access barriers. “Non-communicable diseases like cancer pose huge access challenges, especially in LMICs. That’s why this patient reach of nilotinib is so meaningful. It’s a powerful proof of concept that strategic partnerships and the approach of the Coalition work, bringing together complementary skills and expertise of relevant partners to tackle such a complicated disease. We’re proud to be part of making this happen,” said Charles Gore, Executive Director of MPP.

Along with facilitating the access to generic nilotinib in LMICs, the ATOM Coalition with its partners is now actively working on tailoring capacity strengthening activities to the needs of individual countries, ensuring sustainable long term access to the medicine can be achieved.

“Working with ATOM Coalition partners, we ensure that solutions like the delivery of nilotinib are not just one-time wins, but part of a sustainable and scalable model to strengthen oncology supply chains in LLMICs,” said Harm Veerkamp, Director of Procurement Services and NCDconnect, IDA Foundation.

The ATOM Coalition, led by the Union for International Cancer Control (UICC), is a global initiative that tackles systemic barriers to cancer care in LLMICs by improving access to critical medicines and diagnostics. The Coalition is committed to addressing the challenges of availability, affordability, and appropriate use of oncology medicines and diagnostics in LLMICs.