FDA Approves FoundationOne Liquid CDx as Companion Diagnostic Test for Piqray Treatment

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FoundationOne CDx FDA

The U.S. Food and Drug Administration (FDA) has expanded the approval of Foundation Medicine’s FoundationOne Liquid CDx as a companion diagnostic test for identifying advanced or metastatic breast cancer patients suitable for treatment with Novartis‘ Piqray (alpelisib).

The approval covers men and postmenopausal women who have experienced disease progression during or after endocrine therapy.

Additional new indications include those for patients with advanced ovarian cancer who may benefit from treatment with Rubraca (rucaparib) and for treatment with Alecensa (alectinib) in patients with a certain type of metastatic non-small cell lung cancer (mNSCLC).

A companion test is used to match a patient to a specific therapy. In the case of FoundationOne Liquid CDx, the test examines 324 genes from circulating tumor cells — cancer cells shed from the primary tumor or its metastases —that circulate in the blood.

“FoundationOne Liquid CDx offers oncologists an important and minimally invasive tool to consider when making treatment decisions for their patients, regardless of the type of cancer they have,” Brian Alexander, MD, chief medical officer at Foundation Medicine, said in a press release.

Before prescribing Piquray, clinicians can use FoundationOne Liquid CDx to assess which patients carry mutations in the PIK3CA gene and are suitable for the therapy. Companion diagnostic tests also can be used to assess the effectiveness of a treatment and serious side effects.

Approximately 40% of hormone receptor-positive and human epidermal growth factor receptor-2-negative (HR+/HER2-) breast cancers harbor a mutation in the gene PIK3CA. Mutations in this gene boost the activity of molecular pathways that drive cellular proliferation, causing tumor growth and progression. Moreover, individuals with PIK3CA mutations are more likely be resistant to hormone-based treatments, and have a poor overall prognosis.

Piquray, indicated to be used in combination with AstraZeneca‘s Faslodex (fulvestrant), works by disrupting these molecular pathways. Faslodex works by blocking cancer-promoting estrogen signaling.

Piquray, in combination with Faslodex, is approved in the U.S. and the European Union as a treatment for advanced or metastatic HR+/HER2- breast cancers that harbor a PIK3CA mutation.

The FDA also approved FoundationOne Liquid CDx to assess if patients carry additional copies and alterations in the selected genes of interest.

“These three additional companion diagnostic claims expand the test’s clinical utility into breast and ovarian cancer, demonstrating our commitment to bringing precision medicine to more patients, and we plan to continue working with our biopharma partners to increase that reach,” Alexander said.

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