3 October 2023 - Takeda today announced that, following discussions with the US FDA, it will be working with the FDA towards a voluntary withdrawal of Exkivity (mobocertinib) in the US for adult patients with epidermal growth factor receptor exon20 insertion mutation positive (insertion positive) locally advanced or metastatic non-small cell lung cancer whose disease has progressed on or after platinum-based chemotherapy. 

Takeda intends to similarly initiate voluntary withdrawal globally where Exkivity is approved and is working with regulators in other countries where it is currently available on next steps.

Read Takeda press release