Geneva – The Medicines Patent Pool (MPP), the Access to Oncology Medicines Coalition (ATOM Coalition), IDA Foundation, and The Max Foundation (Max) are thrilled to report that MPP sublicensee Hetero has obtained FDA tentative approval for its generic version of nilotinib indicated for the treatment of chronic myeloid leukaemia (CML), becoming the first among four selected manufacturers to do so. The FDA’s approval of Hetero’s generic nilotinib is a significant step forward in increasing access to cancer treatments in low- and middle-income countries (LMICs).

The sublicence agreements with Eugia, Hetero, Dr. Reddy’s Laboratories, and BrightGene, established in June 2023 were conducted following the signing of a licence agreement between MPP and Novartis Pharma AG in October 2022. These agreements enable the production and distribution of generic nilotinib in the licensed territory, subject to each territory’s regulatory approval.

Charles Gore, Executive Director of MPP said: “The FDA’s tentative approval of Hetero’s generic version of nilotinib is a landmark achievement in our mission to enhance access to life-saving treatments for non-communicable diseases. It is not only a milestone for Hetero but also for the global health community, as it paves the way for broader distribution of essential cancer medication under the public health oriented voluntary licensing mechanism.”

Dan Milner, Executive Director of the UICC-led Access to Oncology Medicines Coalition (ATOM Coalition), said: “The recent FDA approval of Hetero’s generic nilotinib represents a critical advancement in the ATOM Coalition‘s efforts to broaden access to oncology drugs, in targeted and underserved regions. It exemplifies the power of collective action and the impact of strategic partnerships.”

Harm Veerkamp, NCDconnect Director, said: “We’re thrilled to see this important milestone achieved—thanks to the Medicines Patent Pool’s agreement with Novartis and the FDA’s approval of Hetero’s generic nilotinib. This progress brings hope to those affected by chronic myeloid leukaemia, as it paves the way for more affordable treatment options. Through NCDconnect—our digital procurement platform—we’re proud to play a key role in sourcing and ensuring the availability of this life-saving medicine, helping make a tangible difference for patients worldwide.”

Pat Garcia-Gonzalez, The Max Foundation CEO, said: “The Max Foundation has been committed to enable access to innovative cancer drugs in LMIC for more than 20 years. This FDA approval enables one of the several pathways that ATOM Coalition is facilitating to improve the lives of underserved populations. We are honored to be part of ATOM Coalition and contribute to expanding access to quality drugs and reach more CML patients in the future”

Dr. Vamsi Krishna Bandi, MD & CEO of Hetero, said, “Hetero is proud to be at the forefront of expanding access to vital cancer treatments in low- and middle-income countries. With our advanced manufacturing facilities, we are well positioned to ensure availability to nilotinib. We deeply value our partnership with MPP and are honoured to collaborate on this critical initiative to improve global access to cancer drugs”

This development is crucial, considering the World Health Organization’s report on the increasing cancer cases and mortality in LMICs. The licence also presents an opportunity to address the growing need for accessible cancer treatments in these regions.

Nilotinib is a twice daily oral medication used to treat CML, part of the World Health Organization Model List of Essential Medicines (WHO EML) for treatment in adults and children of at least one year of age

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