FoundationOne CDx is a FDA-approved broad companion diagnostic that is clinically validated for solid tumors


Foundation Medicine secured US FDA approval for FoundationOneCDx as companion diagnostic for Pemazyre. (Credit: Pixabay/Belova59)

Foundation Medicine has secured the US Food and Drug Administration (FDA) approval for its sequencing based diagnostic device FoundationOne CDx as companion diagnostic for Pemazyre (pemigatinib).

FoundationOne CDx is said to be the first FDA-approved broad companion diagnostic intended for solid tumors. Currently, it has been approved as the companion diagnostic test for around 20 therapies across multiple cancer types.

Foundation Medicine chief medical officer Brian Alexander said: “The approval of this therapy and companion diagnostic is an important step forward in advancing care for patients with cholangiocarcinoma for whom there are limited treatment options.

“The breadth and depth of our sequencing allows for identification of patients with this rare fusion who may benefit from Pemazyre, underscoring the importance of comprehensive genomic profiling in cholangiocarcinoma.

“We continue to work toward broadening patient access to biomarker-driven therapies, illustrated by this recent milestone. We are proud to add another important FDA-approved companion diagnostic to FoundationOne CDx.”

FDA approved Incyte’s Pemazyre for the treatment of metastatic cholangiocarcinoma

Cholangiocarcinoma is a rare type of cancer, which has been classified based on its origin. The intrahepatic cholangiocarcinoma occurs in the bile duct inside the liver and extrahepatic cholangiocarcinoma occurs in the bile duct outside the liver.

Pemazyre is a selective fibroblast growth factor receptor (FGFR) inhibitor developed by US-based pharmaceutical firm Incyte, to treat previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

In addition, Pemazyre is said to be a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which has showed selective superior pharmacologic activity against cancer cells with FGFR alterations, in preclinical studies.

The FDA approval for the novel therapy and companion diagnostic would enable healthcare professionals to use the company’s comprehensive genomic profiling (CGP) assay FoundationOne CDx to identify patients with FGFR2 fusions select rearrangements who may benefit from treatment with Pemazyre.

Target Cancer Foundation executive director Jim Palma said: “Patients with rare cancers like cholangiocarcinoma often face additional challenges when it comes to available research and treatment options for their condition. The approval of this therapy and companion diagnostic is a turning point for these patients and the rare cancer community as a whole.

“Not only could it be lifechanging for cholangiocarcinoma patients with FGFR2 fusions and select rearrangements, but it reinforces the critical need for comprehensive genomic profiling and the power of collaboration among scientists, clinicians, patients and advocacy organizations.”