Brukinsa access program extended to reach about 1,000 CLL patients

A global program curated by the partnership of BeOne Medicines, its BeOne Care Foundation and The Max Foundation that expands access to the blood cancer drug Brukinsa (zanubrutinib) for patients with chronic lymphocytic leukemia (CLL) in low- and middle-income countries has been extended through 2028, with a goal of reaching about 1,000 patients cumulatively, according to a news release.

The partnership builds on a collaboration the three organizations launched in 2023. Since then, it has provided access to Brukinsa for more than 300 patients with CLL in Armenia, Ethiopia and Nepal, exceeding the program’s original scope by about 150 patients.

Under the renewed agreement, The Max Foundation will continue running the on-the-ground access program, drawing on its experience operating oncology access efforts in low-resource settings. BeOne is donating the Brukinsa needed for patient treatment, and the BeOne Care Foundation is providing a $1 million grant over the next two years to support patient care, physician engagement and program infrastructure.

According to the release, the program will continue supporting patients in Armenia, Ethiopia and Nepal and could expand into Côte d’Ivoire, Malawi, Mongolia, Mozambique, Togo and Zambia depending on operational readiness, bringing access to patients in those countries for the first time. Patients already enrolled will keep receiving Brukinsa beyond the partnership’s 2028 end date for as long as they medically need it, according to the announcement.

The Max Foundation has worked in global cancer access for 28 years and says it has connected more than 100,000 people with cancer or other critical illnesses in low- and middle-income countries to treatment. The BeOne Care Foundation is a separate nonprofit that BeOne established to fund programs aimed at removing barriers to cancer care in underserved communities.

CLL is the most common form of leukemia in adults, accounting for roughly a third of new leukemia cases and an estimated 191,000 new diagnoses worldwide each year. Despite treatment advances in wealthier countries, patients in many low- and middle-income countries still have limited or no access to newer cancer therapies, including BTK inhibitors such as Brukinsa.

Brukinsa is a Bruton’s tyrosine kinase, or BTK, inhibitor that BeOne says has treated more than 300,000 patients across more than 80 markets worldwide. Its FDA label carries warnings for serious risks, including hemorrhage, infections, low blood cell counts and heart rhythm problems, that require monitoring wherever a patient is treated.

The announcement follows a strong second quarter for BeOne, which on Aug. 5 reported $1.7 billion in product revenue, up 29% from a year earlier, driven largely by continued growth in Brukinsa sales.

“From the beginning, our goal has been to ensure that where a person lives does not determine whether they can access high-quality cancer care,” John V. Oyler, co-founder, chairman and CEO of BeOne Medicines, said in today’s news release. “Renewing this partnership with The Max Foundation reflects both the impact we have already achieved together and our commitment to reaching many more patients who otherwise may have limited treatment options.”

Pat Garcia-Gonzalez, co-founder and CEO of The Max Foundation, also said in the news release, the Foundation welcomes the partnership’s commitment to “expanding access to CLL treatment to more countries, patients and families, bringing dignity and hope to those in need.”