Ascentage Pharma advances olverembatinib for SDH-deficient GIST patients

Ascentage Pharma, a leading biopharmaceutical company, has achieved a significant milestone with the approval from China's NMPA for a Phase III study of olverembatinib in patients with SDH-deficient gastrointestinal stromal tumor (GIST) who have not responded to previous treatments.

GIST is a type of soft tissue sarcoma affecting the gastrointestinal tract, with specific mutations driving the disease. SDH-deficient GIST, a subtype with unique challenges, lacks standard treatment options. Ascentage Pharma's olverembatinib, a third-generation TKI, has shown promise with a high clinical benefit rate in early studies.

The Phase III study aims to evaluate the effectiveness and safety of olverembatinib in SDH-deficient GIST patients, addressing the unmet medical needs in this specific population. The drug's Breakthrough Therapy Designation in China highlights its potential to benefit patients who have not responded to other TKIs.

Ascentage Pharma's dedication to developing innovative therapies for cancer and other diseases underscores its commitment to improving patient outcomes globally. The company's focus on advancing olverembatinib's clinical development signifies a step forward in the fight against solid tumors and offers hope to those in need of effective treatments.