Takeda Oncology’s Exkivity treats non-small lung cancer in patients with EGFR exon 20 insertion mutations.
Onco360, an independent oncology pharmacy, has been selected by Takeda to be a specialty pharmacy partner for Exkivity (mobocertinib), the first oral treatment option for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
Onco360 dispenses nationally through its network of URAC-, and ACHC-accredited oncology pharmacies. Onco360 is headquartered in Louisville, Kentucky, and is a flagship specialty pharmacy brand of PharMerica Corporation, a leading institutional pharmacy, specialty infusion, and hospital services company servicing healthcare facilities in the United States.
The FDA approved Exkivity on September 15, 2021. Exkivity, which was granted priority review and received breakthrough therapy designation, fast track designation, and orphan drug designation from the FDA, is the second approval for this indication and the first approved oral therapy to target EGFR exon 20 insertion mutations.
This indication is approved under accelerated approval based on overall response rate and duration of response. The FDA approval is based on results from the platinum-pretreated population in the phase 1/2 trial of Exkivity in patients who had received prior platinum-based therapy. Results were presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting In May. In this trial, the therapy demonstrated an overall response rate of 28% as well as a median duration of response of 17.5 months, a median overall survival of 24 months.