ATOM Coalition welcomes FDA’s approval of generic cancer medicine, nilotinib
FDA approval of a generic nilotinib marks a breakthrough in expanding access to affordable chronic myeloid leukaemia treatment in low- and middle-income countries, exemplifying the success of collaborative licensing and global partnerships.
HIGHLIGHTS
- Hetero, a sublicensee of Medicines Patent Pool (MPP), gained FDA approval to produce generic nilotinib, a critical treatment for chronic myeloid leukaemia (CML), listed on the WHO's List of Essential Medicines.
- This is the first cancer drug licensed through MPP's public health-oriented voluntary licensing model, broadening access via partnerships with companies such as Dr Reddy’s and Eugia.
- ATOM Coalition integrates licensing, digital procurement platforms such as IDA’s NCDconnect, and donations to improve drug availability, affordability, and quality in underserved regions.
- Collaborative efforts with healthcare providers, governments, and regulators streamline product registration and importation, accelerating equitable access to life-saving medicines.
Medicines Patent Pool (MPP), IDA Foundation and The Max Foundation (Max), partners in the Access to Oncology Medicines Coalition (ATOM Coalition), have marked a key milestone with the approval of the generic version of nilotinib by the US Food and Drug Administration (USFDA).
MPP’s sublicensee, Hetero, can now produce generic nilotinib, for the treatment of chronic myeloid leukemia (CML), paving the way for its distribution in target countries. Nilotinib is listed on the World Health Organization's List of Essential Medicines for the treatment of adults and children over the age of one suffering from CML.
The twice-daily oral medicine was the first license MPP signed for a cancer treatment and the first time a company licensed a patented cancer medicine through a public health-oriented voluntary licensing mechanism.
Hetero is among three other MPP sublicensees including Eugia, Dr. Reddy’s Laboratories, and Bright Gene – subcontracted to produce and distribute the drug within licensed territories, following a successful agreement between MPP and Novartis Pharma AG in October 2022. While subject to country regulatory approvals, the distribution of generic nilotinib could significantly impact access to the treatment of CML in low- and middle-income countries.
“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.”
– Dr Dan Milner, Executive Director of the UICC-led ATOM Coalition
The ATOM Coalition’s access to medicines model features key pathways that allow innovator or generic pharmaceutical companies to deliver their cancer medicines to ATOM Coalition target countries in alignment with their access strategies, while being sustainable and affordable. MPP’s voluntary licensing is among the four pathways for pharmaceutical companies to deliver cancer medicines. These pathways include licensing, indirect commercialisation, IDA’s NDCconnect platform and donations or Max Foundation’s humanitarian access of approved oncology products.
Earlier this year, ATOM Coalition partnered with IDA Foundation to address challenges related to the availability, affordability, quality assurance, and appropriate use of oncology medicines, and establish another sustainable access pathway through IDA’s digital procurement platform, NCDconnect. Through NCDconnect, nilotinib sourced from Hetero is now globally accessible to low- and lower middle-income countries (LLMICs). This effort includes close collaboration with local governments, healthcare providers, and regulatory authorities to expedite product registrations. The Max Foundation will assist in the implementation.
By leveraging the collective expertise of ATOM Coalition partners and strategic collaborations with pharmaceutical companies, the Coalition remains committed to ensuring equitable access to life-saving cancer medicines.
Last update
Wednesday 19 February 2025
