FDA Approves FoundationOne CDx Companion Diagnostic for Selpercatinib in RET+ Solid Tumors

FDA

The FDA has approved FoundationOne® CDx for use as a companion diagnostic for selpercatinib (Retevmo), which was approved by the FDA for the treatment of adult patients with locally advanced or metastatic solid tumors harboring a RET gene fusion whose disease has progressed on or following prior systemic treatment, or who have no satisfactory alternative treatment options.¹

FoundationOne CDx is a next-generation sequencing–based in vitro diagnostic device designed to detect substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements. Additionally, the diagnostic can detect genomic signatures such as microsatellite instability and tumor mutational burden through DNA isolated from formalin-fixed, paraffin-embedded tumor tissue specimens.

“With a growing need for solutions for patients with rare fusions, high-quality companion diagnostics provide critical information to support oncologists in the development of personalized treatment plans,” Mia Levy, MD, PhD, chief medical officer at Foundation Medicine, stated in a news release. “With our experience successfully navigating the complexities of a pan-tumor approval, we’re proud to have another companion diagnostic for our FDA-approved tissue test that can help enable broader access to an important therapy option for RET fusion–positive solid tumors. We appreciate this meaningful collaboration with Lilly to help bring more treatment options to patients facing a cancer diagnosis.”

In September 2022, the FDA granted regular approval to selpercatinib for the treatment of adult patients with RET fusion–positive, locally advanced or metastatic non–small cell lung cancer.² On the same day, the regulatory agency also granted accelerated approval to selpercatinib for the treatment of adult patients with locally advanced or metastatic solid tumors harboring a RET gene fusion who have progressed on or after previous systemic treatment, or who have no satisfactory alternative treatment options.³

“One of our top priorities is helping people living with lung cancer access the best treatment possible and this approval marks a milestone on the path to developing highly personalized care for them,” Laurie Ambrose, president and chief executive officer of GO2 for Lung Cancer, said in a news release.1 “We are encouraged by the expanded access and options they will receive and are confident this will positively impact the lives of people living with cancer and their loved ones.”

FoundationOne CDx now has 5 pan-tumor approvals from the FDA, and it has 9 companion diagnostic indications across 7 gene fusions, including ALK, ROS1, NTRK1/2/3, FGFR2, and RET.

Most recently, on August 14, 2023, the FDA approved FoundationOne CDx to be utilized as a companion diagnostic for the dual-action tablet (Akeega) of niraparib (Zejula) plus abiraterone acetate (Zytiga), which was approved for use in combination with prednisone in adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer.⁴

References

1. U.S. Food and Drug Administration (FDA) approves FoundationOne CDx as a companion diagnostic for Lilly’s Retevmo (selpercatinib) for certain patients with solid tumors. News release. Foundation Medicine. October 9, 2023. Accessed October 10, 2023. https://www.foundationmedicine.com/press-releases/0a64663c-41b5-412f-86c1-fa2399db880e
2. FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive non-small cell lung cancer. News release. FDA. September 21, 2022. Accessed October 10, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive-non-small-cell-lung
3. FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors. News release. FDA. September 21, 2022. Accessed October 10, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive-solid-tumors
4. US Food and Drug Administration (FDA) approves FoundationOne CDx as a companion diagnostic for Janssen’s Akeega (niraparib and abiraterone acetate dual action tablet) for patients with BRCA-positive metastatic castration-resistant prostate cancer. News release. Foundation Medicine. August 14, 2023. Accessed October 10, 2023. https://www.foundationmedicine.com/press-releases/77d12149-fab5-443c-8e7a-1b46085bb1c2