Innovent Biologics’ olverembatinib gets Chinese breakthrough therapy status in SDH-deficient GIST


Innovent Biologics has been granted breakthrough therapy designation (BTD) for olverembatinib from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA).

The breakthrough therapy designation has been given to olverembatinib as a treatment for succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) patients who have received first-line treatment.

The designation was based on the results from an ongoing phase 1b/2 clinical trial conducted in China. The early-stage study demonstrated a clinical benefit rate (CBR) of 93.8% among patients with this specific subtype of GIST.

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Olverembatinib is a third-generation BCR-ABL inhibitor and the first of its kind to receive approval in China for the treatment of adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic-phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) with the T315I mutation, as confirmed by a validated diagnostic test. The drug is jointly commercialized in China by Ascentage Pharma and Innovent Biologics.

This marks the second breakthrough therapy designation granted to olverembatinib by the CDE, with the first designation received in March 2021 for the treatment of patients with CML-CP resistant and/or intolerant to first- and second-generation TKIs.

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Following the acceptance of a new drug application (NDA) for the initial breakthrough therapy designation indication in July 2022, olverembatinib was granted priority review designation, positioning it for full approval by the NMPA.

The NMPA’s breakthrough therapy designation aims to accelerate the development and review process for investigational drugs that address serious diseases or conditions and demonstrate substantial improvements over existing therapies based on preliminary clinical evidence. This designation provides a pathway for olverembatinib to undergo an expedited regulatory review and potentially bring this innovative treatment to patients in need more swiftly.

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Dr Hui Zhou — Innovent Biologics Senior Vice President said: “We are glad to see the NMPA grants another BTD for olverembatinib, marking a major milestone in its clinical development and demonstrating its therapeutic potentials beyond hematologic malignancies. We look forward to more good news of olverembatinib that allow more patients to benefit from this novel drug as soon as possible.”

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