FDA Approves Companion Diagnostic for Selpercatinib in RET Fusion+ Solid Tumors

• The FoundationOne® companion diagnostic (CDx) detects substitutions, insertions, and deletions in 324 genes and gene arrangements.

• The CDx is approved for use with selpercatinib (Retevmo) for the treatment of tumors with a RET gene fusion.

• The FDA approved selpercatinib in September 2022.

The FDA has granted approval to the FoundationOne® CDx for use as a companion diagnostic for selpercatinib (Retevmo) 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, according to Foundation Medicine Inc.¹

“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, in a press 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 [Eli] Lilly to help bring more treatment options to patients facing a cancer diagnosis.”

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device which detects substitutions, insertion alterations, deletion alterations, and copy number alterations in 324 genes and select gene rearrangements. The CDx can also detect genomic signatures, including microsatellite instability and tumor mutational burden through DNA by utilizing formalin-fixed, paraffin-embedded tumor tissue specimens.

In September 2022, the FDA approved 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, based on findings from the LIBRETTO-001 trial (NCT03157128).² In the study, selpercatinib yielded robust and durable responses after more than 20 months of follow-up.

Simultaneously, the FDA granted a traditional approval to selpercatinib for the treatment of adults with locally advanced or metastatic NSCLC with a RET gene fusion, as detected by an FDA-approved test.

“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 Laurie Ambrose, president and chief executive officer of GO2 for Lung Cancer, in a press 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.”

The FDA has now granted 5 approvals to the FoundationOne CDx. Additionally, there are 9 companion diagnostic indications across 7 gene fusions, including ALK, ROS1, NTRK1/2/3, FGFR2, and RET.

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://tinyurl.com/2p9r87t6

2. Drilon A, Subbiah V, Gautschi O, et al. Selpercatinib in patients with RET fusion–positive non–small-cell lung cancer: updated safety and efficacy from the registrational libretto-001 phase I/II trial.Published September 19, 2022. J Clin Oncol. doi:10.1200/JCO.22.00393