Foundation Medicine received a new companion diagnostic approval from the FDA for its FoundationOne CDx test—the product’s 19th indication, now for selecting breast cancer patients for treatment with Novartis’ Piqray targeted therapy.
Piqray (alpelisib) received the agency greenlight in May. Given in combination with Faslodex (fulvestrant), it was the first drug approved for men and postmenopausal women with advanced or metastatic HR-positive, HER2-negative breast cancer with a PIK3CA mutation.
It was also the first drug to make it through the FDA’s Real-Time Oncology Review pilot program for breakthrough cancer therapies, and it’s one that Novartis hopes will achieve blockbuster status, and soon. In its first full quarter of sales this year, Piqray brought in $43 million, and the company is planning future filings in HER2+ and triple negative breast cancer, as well as in ovarian cancer and squamous cell carcinoma of the head and neck.
Associated with a poor disease prognosis, PIK3CA mutations are the most common ones seen in HR+/HER2- breast cancer, and cover about 40% of cases. According to Foundation, professional practice guidelines were updated this year following Piqray’s approval, to include assessments of PIK3CA status as part of standard genetic testing of late-stage HR+/HER2- breast cancer patients.
Parallel with Piqray’s May approval, rival diagnostics maker Qiagen announced the regulatory clearance and launch of its own companion test, the therascreen PIK3CA RGQ PCR Kit. Co-developed with Novartis and licensed from Johns Hopkins University, its assay detects 11 relevant PIK3CA mutations in liquid and solid biopsy samples. Last month, Qiagen disclosed it has begun fielding buyout offers from multiple companies, including Thermo Fisher Scientific.
The FoundationOne CDx test incorporates multiple companion diagnostics, spanning 324 genes and rearrangements, and it is the first broad comprehensive genomic profiling test approved by the FDA for all solid tumors.
Foundation Medicine and Novartis previously launched a broad collaboration in October 2018 to develop companion diagnostics across the Swiss drugmaker’s oncology portfolio. That partnership includes development and regulatory support, as well as the commercialization of tests on the company’s FoundationOne CDx platform.