FDA Approves Generic Nilotinib: Expanding Access to Chronic Myeloid Leukemia Treatment

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 (US FDA).

Hetero, a sublicensee of the Medicines Patent Pool (MPP), has received approval to produce generic nilotinib, a medication used to treat chronic myeloid leukemia (CML). This development opens the door for its distribution in designated countries.

Nilotinib, included in the World Health Organization’s List of Essential Medicines, is approved for treating CML in adults and children over one year old.

This twice-daily oral treatment is MPP’s first licensed cancer medicine and the first patented cancer drug licensed through a public health-focused voluntary licensing model.

Hetero is one of four MPP sublicensees, alongside Eugia, Dr. Reddy’s Laboratories, and Bright Gene, authorized to manufacture and distribute nilotinib under an agreement reached between MPP and Novartis Pharma AG in October 2022.

Pending regulatory approval in individual countries, the availability of generic nilotinib could greatly enhance access to CML treatment in low- and middle-income nations.

“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 model for improving access to cancer medicines includes several pathways that enable pharmaceutical companies, both innovator and generic, to supply treatments to target countries in a sustainable, affordable manner aligned with their access strategies.

Among these pathways is MPP’s voluntary licensing, alongside indirect commercialization, the IDA Foundation’s NCDconnect platform, and humanitarian access through donations or the Max Foundation.

Earlier this year, the ATOM Coalition partnered with the IDA Foundation to enhance access to oncology medicines through the NCDconnect digital procurement platform.

As part of this initiative, generic nilotinib, sourced from Hetero, is now available to low- and lower-middle-income countries (LLMICs). The partnership also involves collaboration with local governments, healthcare providers, and regulatory authorities to fast-track product registration.

Additionally, the ATOM Coalition and IDA Foundation are addressing key barriers to cancer medicine access, including availability, affordability, quality assurance, and appropriate usage. The Max Foundation is supporting the implementation process for these efforts.

By combining the expertise of its partners and fostering strategic collaborations with pharmaceutical companies, the ATOM Coalition remains dedicated to advancing equitable access to life-saving cancer treatments.

UICC:

“The FDA has approved a generic version of nilotinib, a vital treatment for chronic myeloid leukaemia (CML), enhancing access in low- and middle-income countries.

This achievement is largely driven by the ATOM Coalition, along with partnerships with Medicines Patent Pool and Hetero. Through initiatives like NCDconnect and continued collaboration, ATOM is helping pave the way for affordable, life-saving medicines to reach those who need them most.”

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