#China #Olverembatinib #CML #Suzhou #Ascentage Pharma

New Indication of Olverembatinib in China's National Reimbursement Drug List

Ascentage Pharma, a global player in the biopharmaceutical sector, has made an important announcement regarding its innovative cancer drug, olverembatinib. The company revealed that a new indication for this medication has been added to China's National Reimbursement Drug List (NRDL) for 2024. This addition is set to take effect on January 1, 2025, and signifies a major step in improving treatment options for patients suffering from chronic myeloid leukemia (CML).

Who Benefits From This New Indication?

The newest indication is specifically aimed at adult patients with chronic-phase CML who are resistant or intolerant to first- and second-generation tyrosine kinase inhibitors (TKIs). The inclusion of this indication in the NRDL is a significant advancement, as approximately 20%-40% of CML patients experience complications due to resistance or intolerance to existing treatments. The renewal process for adding this indication was straightforward, which reflects the growing clinical acceptance of olverembatinib.

Previously, the drug was included in the NRDL for patients with CML harboring the T315I mutation. This mutation is often associated with high resistance to first- and second-generation TKIs, making olverembatinib a critical option for these patients. The drug has been recognized for its ability to effectively target BCR-ABL mutations, providing a ray of hope for those whose treatment options were limited.

The Development Journey of Olverembatinib

Olverembatinib stands out as the first third-generation BCR-ABL inhibitor that China approved, developed with the backing of the National Major New Drug Development Program in China. The drug received its first approval in November 2021, solely for treating patients with T315I mutant CML. Just two years later, it gained further approval for patients resistant to other TKIs, showcasing its role in addressing significant unmet medical needs in the oncology sector.

The innovative development of olverembatinib represents Ascentage Pharma's commitment to improving cancer treatment outcomes. The CEO of Ascentage, Dr. Dajun Yang, expressed optimism regarding this inclusion, stating, "This decision underscores the significance of olverembatinib as an innovative option for CML patients, particularly for those facing resistance to other therapies. We aim to ensure rapid implementation of expanded insurance coverage, allowing broader access to this crucial treatment."

Future Prospects and Ongoing Research

Ongoing trials continue to evaluate olverembatinib not just for CML, but also for other hematologic malignancies such as acute lymphoblastic leukemia (ALL). There is a global Phase III study currently underway that aims to determine the efficacy of olverembatinib in newly diagnosed Ph+ ALL patients.

Moreover, the drug is being tested in clinical studies focused on gastrointestinal tumors, marking its potential expansion beyond hematological applications. The increasing interest in olverembatinib from the global medical community is evidenced by its selection for oral presentations at numerous prestigious medical conferences, including the American Society of Hematology (ASH) Annual Meetings.

Dr. Yang concluded with hopeful remarks regarding the impact of olverembatinib on patients' lives. "With this new inclusion in the NRDL, we are optimistic about strengthening the landscape of CML treatment in China. Our commitment remains to enhance the accessibility of vital medications and improve the lives of countless patients and their families."

The drug has been designated as an Orphan Drug by relevant agencies and has received Breakthrough Therapy designations, reflecting its potential in revolutionizing treatment protocols for CML. However, it's important to note that olverembatinib is still considered investigational outside of China, and its international prospects are being actively pursued.

As Ascentage Pharma continues to develop olverembatinib and expand its use, the hopeful narrative surrounding modern cancer treatments progresses, potentially redesigning the landscape for patients grappling with challenging malignancies like CML.