2019-12-09| R&DTrials & Approvals

FoundationOne®CDx Approved as Companion Diagnostic for Novartis’ Piqray

by Rajaneesh K. Gopinath
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FoundationOne®CDx is a comprehensive genomic profiling test that became the first FDA approved broad companion diagnostic for all solid tumors. Last week, the genomic biomarker assay bagged FDA approval for its 19th indication.

Genetic testing is increasingly becoming a prerequisite for patients who are on their way to a cancer diagnosis and treatment. In screening for cancer, standard methodologies such as immunohistochemistry, FISH, and PCR helped physicians only to look for a handful of previously known mutations but the advent of next-generation sequencing improved that number. However, comprehensive genomic profiling (CGP) is a test that examines all the different classes of cancer-relevant mutations taking the entire coding region of a gene into account. In an exclusive interview with GeneOnline, Dr. Nicolas Martin, International Scientific Lead at Roche Foundation Medicine had likened the CGP technology to switching on a ceiling light in a dark room as compared to the earlier methods which are akin to using hand torches.

FDA Approval for 19th Indication

FoundationOne®CDx has been FDA approved based on stringent analytical and clinical validations of more than 6,300 samples. As an acknowledgment of this quality, it had been approved as a companion diagnostic for 18 FDA-approved targeted therapies previously. On December 4th, the company announced its FDA approval as a companion diagnostic for Piqray® (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women, and men, with HR+/HER2-, PIK3CA mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen. Piqray is the first and only treatment specifically for patients with this indication and was FDA approved last May. This is a result of an ongoing collaboration between Foundation Medicine and Novartis to develop companion diagnostics for the latter’s oncology portfolio.

“Foundation Medicine is proud to achieve another FDA approval for FoundationOne®CDx as a companion diagnostic for Piqray for the treatment of metastatic breast cancer with a PIK3CA mutation,” stated Brian Alexander, M.D., M.P.H. Foundation Medicine’s Chief Medical Officer. “The advancements we are seeing in the treatment of breast cancer underscore the importance of harnessing genomic insights to enable personalized medicine. Taking a comprehensive and validated approach to genomic testing is critical for patients with metastatic breast cancer to help physicians determine a treatment roadmap upfront that may include FDA-approved targeted therapies like Piqray.”


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