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FDA Updates: Actions on Companion Diagnostics; Xarelto Seeks New PAD Indication


FDA approves new uses for companion diagnostics, while Janssen seeks a new indication for Xarelto.

Foundation Medicine approvals. FDA this week approved new and expanded indications for Foundation Medicine’s liquid biopsy assay and its tissue-based companion diagnostic for solid tumors. Regulators approved the Liquid CDx as a companion diagnostic to identify patients who may benefit from selected targeted therapies, including Piqray (alpelisib), Rubraca (rucaparib), and Alecensa (alectinib). Piqray is used in the treatment of breast cancer, while the PARP inhibitor Rubraca is approved in the treatment of advanced ovarian cancer. Alecensa is approved for the treatment of certain patients with non-small cell lung cancer (NSCLC). The new Liquid CDx approvals expand the test’s clinical utility in guiding treatment for breast and ovarian cancer, the company said in a statement. FDA also expanded the test’s label, and said it can be used to report certain copy number alterations and genomic rearrangements.

Also, the assay was granted approval as a companion diagnostic to identify patients with metastatic castration-resistant prostate cancer patients with certain BRCA1/2 alterations eligible for treatment with a PARP inhibitor, as well as those patients whose NSLCLC would benefit from treatment with an EGFR tyrosine kinase inhibitor (TKI).

Roche companion diagnostic. This week, FDA approved Roche’s cobas EGFR mutation test v2 as a companion diagnostic test for expanded EGFR TKI. According to a statement from Roche, the expansion allows the test to be used as companion diagnostic for all five currently FDA-approved EGFR TKI therapies that target EGFR mutations L858R and Exon 19 Deletions, based on product labeling, and will allow the test to be used for any future EGFR TKI therapies approved to target these mutations. The cobas EGFR mutation test v2 is a real-time polymerase chain reaction (PCR) test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients.

Janssen files for additional PAD indication. Janssen this week submitted a supplemental new drug application for Xarelto (rivaroxaban) plus aspirin to reduce the risk of major thrombotic vascular events in patients after lower-extremity revascularization due to symptomatic peripheral artery disease (PAD). The drug is currently approved to cut the risk of events such as heart attacks and strokes in patients with PAD, a condition that may affect up to 20 million Americans and can lead to lower limb amputation if left untreated. A ProPublica investigation earlier this year found that Black patients in underserved areas who develop PAD are experiencing amputations at an alarming rate.

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