The Center for Drug Evaluation (CDE) has indicated on its website that two indications for its in-house developed bispecific antibody drug conjugate (ADC), BL-B01D1, are on track to receive breakthrough therapy designations (BTDs). The first indication is for patients with locally advanced or metastatic EGFR wild-type non-small cell lung cancer (NSCLC) who have previously been treated with anti-PD-1/PD-L1 monoclonal antibodies but have failed platinum-based chemotherapy. The second indication is for patients with EGFR mutant locally advanced or metastatic non-squamous NSCLC who have failed EGFR-TKI treatment.
This molecule, which targets EGFR and HER3, was the subject of a significant licensing deal with US pharmaceutical giant Bristol-Myers Squibb at the end of 2023. The deal was valued at USD 8.4 billion, with an upfront payment of USD 800 million, reflecting the high potential of this innovative therapy in addressing significant unmet medical needs in oncology.- Flcube.com
