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

CAMBRIDGE, Mass.–()–Foundation Medicine Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for Eli Lilly and Company’s Retevmo (selpercatinib), which was approved by the FDA for the treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

This announcement marks Foundation Medicine’s fifth pan-tumor approval in the U.S. for FoundationOne CDx, the only tissue test with multiple biomarkers approved as a tumor agnostic companion diagnostic in the U.S., including TMB and NTRK1/2/3. It also marks Foundation Medicine’s ninth approved companion diagnostic indication across 7 different fusion genes (ALK, ROS1, NTRK1, NTRK2, NTRK3, FGFR2, and now RET.)

Using a tissue sample, FoundationOne CDx analyzes more than 300 cancer-related genes for genomic alterations in a patient’s tumor, which allows a tailored treatment approach and will determine if Retevmo is an appropriate treatment option for patients with RET gene fusions, which occur in less than two percent of solid tumors1. The test currently has over 30 companion diagnostic indications, ranging from lung, breast, prostate, colon, and other solid malignancies.

“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,” said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine. “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.”

“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,” said GO2 for Lung Cancer President & CEO Laurie Ambrose. “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.”

Foundation Medicine is the global leader in companion diagnostic approvals. The company also has 60% of all U.S. companion diagnostic approvals for next generation sequencing (NGS) testing. This companion diagnostic approval is the latest in a series of collaborative efforts between Foundation Medicine and Lilly.

Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.

Retevmo® is a registered trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.

About FoundationOne CDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit www.F1CDxLabel.com.

About Foundation Medicine: Your Essential Partner in Cancer Care

Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on Twitter and LinkedIn.

Source: Foundation Medicine


1 https://www.nature.com/articles/s41698-023-00347-2#:~:text=Somatic%20RET%20gene%20alterations%2C%20including,primary%20driver%20variants%20and%20rearrangements.

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