Natera’s Signatera test has received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) as a companion diagnostic in muscle-invasive bladder cancer (MIBC).
The approval, announced Sept. 22, supports using Signatera to guide treatment with Genentech’s atezolizumab (Tecentriq) in MIBC patients.
Natera expects to commercially launch Signatera for MIBC in Japan in the first half of 2027, following the PMDA’s approval of atezolizumab in MIBC, and pending final reimbursement and pricing decisions.
This is Signatera’s second approval in Japan. In June, PMDA approved it as a companion diagnostic in colorectal cancer. The US FDA has also approved Signatera as a companion diagnostic for the same MIBC and atezolizumab indication.
The approval was supported by data from IMvigor011, a randomized, double-blind Phase 3 trial, which included more than 20 participating sites in Japan.
According to Natera, MIBC affects approximately 7,500 people in Japan each year.