China-based InxMed (Nanjing) Co., Ltd has announced that the Center for Drug Evaluation of the National Medical Products Administration (NMPA) has granted a Breakthrough Therapy Designation (BTD) to its innovative small-molecule ifebemtinib (IN10018). The designation is for the use of ifebemtinib, a focal adhesion kinase (FAK) inhibitor, in combination with the KRASG12C inhibitor garsorasib (D-1553) for the treatment of first-line KRASG12C mutant locally advanced or metastatic non-small cell lung cancer (NSCLC).
Global Rights and Previous BTD for Ifebemtinib
InxMed acquired the exclusive development and commercialization rights to IN10018 following a 2017 agreement between its parent company, iPharma Ltd, and Boehringer Ingelheim. This deal secured global manufacturing, development, and commercialization rights for the drug, which was previously known as BI 853520. Ifebemtinib was first awarded a BTD in China in April 2022 for use in combination with pegylated liposomal doxorubicin (PLD) for the treatment of platinum-resistant recurrent ovarian cancer. Additionally, the drug has been granted fast-track status in the United States.
Implications of the BTD for InxMed and NSCLC Treatment
The latest BTD for ifebemtinib underscores InxMed’s commitment to developing novel therapies for difficult-to-treat cancers. The designation not only accelerates the drug’s development and review process in China but also highlights the potential impact of ifebemtinib on the treatment landscape for NSCLC patients, particularly those with KRASG12C mutations.-Fineline Info & Tech
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