FDA Approves FoundationOne CDx for Selpercatinib in RET+ Solid Tumors

News
Article

The FDA companion diagnostic designation for FoundationOne CDx may improve access to treatment with selpercatinib in select patients with solid tumors harboring a RET gene fusion.

The FDA previously approved selpercatinib in RET fusion–positive solid tumors that have progressed following prior systemic therapy in September 2022.

The FDA previously approved selpercatinib in RET fusion–positive solid tumors that have progressed following prior systemic therapy in September 2022.

The FDA has granted approval to the FoundationOne CDx assay as a companion diagnostic to identify patients with locally advanced or metastatic RET fusion–positive solid tumors previously treated with systemic therapies who may be eligible to receive treatment with selpercatinib (Retevmo), according to a press release from 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,” Mia Levy, MD, PhD, chief medical officer at Foundation Medicine, said in the press release.1 “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.”

The FDA previously approved selpercatinib in RET fusion–positive solid tumors that have progressed following prior systemic therapy in September 2022.2 Supporting data for the approval in this indication came from the phase 1/2 LIBRETTO-001 trial (NCT03157128), in which selpercatinib yielded an overall response rate (ORR) of 44% (95% CI, 28%-60%) among 41 patients with RET fusion–positive solid tumors. Additionally, investigators reported ORRs of 55.0% (95% CI, 23.0%-83.0%) in 11 patients with pancreatic adenocarcinoma, 20.0% (95% CI, 2.5%-56.0%) in 10 with colorectal cancer, 50.0% (95% CI, 7.0%-93.0%) in 4 with salivary gland cancer, and 33.0% (95% CI, 0.8%-91.0%) in 3 with unknown primary disease.

“In the LIBRETTO-001 trial, selpercatinib demonstrated clinically meaningful and durable responses across a variety of tumor types in patients with RET-driven cancers, including pancreatic, colon, and other cancers in need of new treatment options,” study co-investigator Vivek Subbiah, MD, associate professor of Investigational Cancer Therapeutics at the University of Texas MD Anderson Cancer Center, said in a press release at the time of the approval.2 “These data and FDA approval of the tumor-agnostic indication underscore the importance of routine, comprehensive genomic testing for patients across a wide variety of tumor types.”

Developers designed the FoundationOne CDx to analyze more than 300 cancer-related genes for alterations in a patient’s tumor, which may determine whether selpercatinib is a suitable therapy for those whose tumors harbor RET fusions. According to the press release, the assay is approved as a companion diagnostic across more than 30 indications, which include lung, breast, prostate, and colon cancer.

The FoundationOne CDx assay is intended only for prescription use among qualified health care professionals based on oncology guidelines for patients with solid malignant neoplasms. Additionally, developers caution that a negative test result may not negate the presence of a genomic alteration, and that patients are not guaranteed to be matched to a suitable treatment.

The FDA also approved selpercatinib in RET fusion-positive non–small cell lung cancer (NSCLC) in September 2022.3 The agency’s approval was based on extended follow-up data from the LIBRETTO-001 trial, which included 316 patients with locally advanced or metastatic RET fusion-positive NSCLC. In the NSCLC cohort, selpercatinib produced an ORR of 84% (95% CI, 73%-92%), and a median duration of response of 20.2 months (95% CI, 13-not estimable).

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 Inc. October 9, 2023. Accessed October 11, 2023. https://bit.ly/3RSQkZE
  2. FDA approves Lilly's Retevmo® (selpercatinib), the first and only RET inhibitor for adults with advanced or metastatic solid tumors with a RET gene fusion, regardless of type. News release. Eli Lilly and Company. September 21, 2022. Accessed October 11, 2023. https://prn.to/3dFC8Bz
  3. FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive non-small cell lung cancer. News release. FDA. September 21, 2022. Accessed October 11, 2023. https://bit.ly/3f6PjMm
Related Videos
Cancer vaccines are a “cross-cutting approach” that may be applicable across several cancer types, according to Catherine J. Wu, MD.
mRNA may be a potential modality for developing cancer-based vaccines, according to Catherine J. Wu, MD.
Analyzing the KRAS mutation across various cancer types may be a worthwhile target when using a cancer vaccine or immunotherapy, says Catherine J. Wu, MD.
The AACR Health Disparities Report highlights the changes needed to achieve health equity for patients with cancer.
Robert A. Winn, MD, gives insight into how institutions and community practices can improve access to cancer care.
In the October edition of Snap Recap, we review the latest FDA news and the vote from the last ODAC meeting.
In this September edition of Snap Recap, we share our highlights from Prostate Cancer Awareness Month, news in the breast cancer space, and the latest FDA updates.
Implementing tax benefits for manufacturers who produce chemotherapy drugs may be one solution to increase drug production in the United States, according to Lucio N. Gordan, MD.
Lucio N. Gordan, MD, describes how his practice deals with increasing costs of limited chemotherapy agents to ensure that patients with cancer continue to receive treatment.
Related Content
Additional research may be necessary to validate the efficacy of telehealth interventions in clinical activities for patients with cancer.

Cancer Symptom Improvements Occur With Telehealth Exercise Program

April 27th 2024
Article

Additional research may be necessary to validate the efficacy of telehealth interventions in clinical activities for patients with cancer.

Edward S. Kim, MD, MBA, and Richard T. Lee, MD discuss how integrative oncology techniques such as acupuncture have impacted patient quality of life at their practice.

Creating a First-of-Its-Kind Integrative Oncology Program at City of Hope

March 18th 2024
Podcast

Edward S. Kim, MD, MBA, and Richard T. Lee, MD discuss how integrative oncology techniques such as acupuncture have impacted patient quality of life at their practice.

Striving for Health Care Equity by Closing the Cancer Care Gap

Striving for Health Care Equity by Closing the Cancer Care Gap

April 18th 2024
Article

“If you were to ask me what the 1 magic thing would be, it would be that we would adopt a concept of 1 team, one fight nationally, and that we would be able to have our structures and our coordination of care.”

Primary care physicians cannot afford to dismiss younger people who present with symptoms of cancer in the face of increasing cancer incidence, according to Monique Gary, DO, MSc, FACS.

Addressing Rising Cancer Incidence and Burden in Younger Populations

March 11th 2024
Podcast

Primary care physicians cannot afford to dismiss younger people who present with symptoms of cancer in the face of increasing cancer incidence, according to Monique Gary, DO, MSc, FACS.

Results from 3 DESTINY trials led to the accelerated approval of fam-trastuzumab deruxtecan-nxki for patients with unresectable or metastatic HER2-positive solid tumors.

FDA Grants Accelerated Approval to T-DXd in Advanced HER2+ Solid Tumors

April 5th 2024
Article

Results from 3 DESTINY trials led to the accelerated approval of fam-trastuzumab deruxtecan-nxki for patients with unresectable or metastatic HER2-positive solid tumors.

Further research may be needed to help determine the underlying mechanisms of polybrominated diphenyl ether exposure contributing to the risk of cancer-related mortality.

PBDE Exposure Confers Significant Cancer Mortality Risk

April 4th 2024
Article

Further research may be needed to help determine the underlying mechanisms of polybrominated diphenyl ether exposure contributing to the risk of cancer-related mortality.