The Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted breakthrough therapy designation (BTD) to Innovent Biologics’ olverembatinib for the treatment of succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumour (GIST).
The designation was granted based on the results from an ongoing Phase Ib/II study of olverembatinib carried out in China.
The study demonstrated a clinical benefit rate of 93.8% in patients with SDH-deficient GIST who had received first-line treatment.
Olverembatinib also received approval for treating patients with chronic myeloid leukemia (CML-CP) resistant and/or intolerant to first- and second-generation tyrosine kinase inhibitors (TKI).
It is said to be the first China-approved third-generation BCR-ABL inhibitor targeting drug-resistant CML-CP harboring the T315I mutation, as confirmed by a validated diagnostic test.
The NMPA accepted a new drug application (NDA) for the first BTD indication in July 2022 and then granted priority review designation that supports a full approval of olverembatinib.
Innovent Biologics senior vice-president Dr Hui Zhou 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.”
Olverembatinib is jointly commercialised in China by Innovent Biologics along with Ascentage Pharma.
In July 2021, Ascentage and Innovent reached the agreement for the joint development and commercialisation of olverembatinib in the country.