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

Original from: businesswire

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.

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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.

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Source: 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