FDA Approves Amgen's Trastuzumab Biosimilar, Kanjinti

The FDA has approved Amgen’s ABP 980, a trastuzumab biosimilar referencing Herceptin. The drug, trastuzumab-anns, will be sold as Kanjinti.

Kanjinti was approved for the treatment of HER2-positive breast cancer and gastric cancer.

The news of the approval comes just a week after the 2019 American Society of Clinical Oncology Annual Meeting, where researchers reported new safety data from the LILAC study that demonstrated that the biosimilar had comparable cardiac safety to the reference product.

The phase 3 LILAC study, results of which were first presented in 2017, showed that, in a head-to-head trial, the biosimilar and the reference were highly similar.

In the double-blind, multicenter study, 725 patients with HER2-positive early breast cancer were randomized to receive the biosimilar or the reference trastuzumab. After 4 cycles of chemotherapy, patients received a neoadjuvant course of their assigned therapy along with paclitaxel for 4 cycles. The efficacy analysis was conducted from tissue collected at surgery.

The study’s primary endpoints were risk differences (RD) and risk ratio (RR) of pathologic complete response (pCR) in breast tissue and axillary lymph nodes by local laboratory and central pathology evaluation.

By local review, the primary pCR endpoint was achieved in 48.0% of those randomized to biosimilar trastuzumab-anns versus 40.5% of those randomized to reference trastuzumab. The advantage for the biosimilar exceeded the prespecified 13.0% margin for bioequivalence by RD. However, the prespecified margins were not exceeded in the central review.

Data in Amgen’s package also included analytical similarity findings.

Today’s approval comes as welcome news for Amgen, which first received a Complete Response Letter for the product in June of 2018, despite having earned European authorization in May 2018.

The approval also marks the 20th biosimilar approved by the FDA.