Precision Oncology Regulatory News

The latest headlines on diagnostics regulation: FDA, CMS, and international regulatory agencies.

FDA Approves Novartis' Piqray for PIK3CA-Mutated Advanced Breast Cancer

Novartis' alpelisib is the first PI3K inhibitor approved for advanced or metastatic breast cancer patients who harbor PIK3CA mutations.

Transgene Moves Ahead With Phase I Study of First Individualized Ovarian Cancer Immunotherapy

The study will evaluate the safety and tolerability of TG4050, which is designed to recognize and destroy tumors using a patient's own cancer-specific genetic mutations.

FDA Grants IDE Approval for Almac Diagnostic Services' CDx for Use in Cancer Drug Study

The next-generation sequencing assay is intended for use in identifying patients with ROS1, NTRK1-3, and ALK gene fusions in advanced solid tumors.

FDA Approves Expanded Use of Agilent CDx for Keytruda in Lung Cancer

The diagnostic can now be used to identify a wider range of patients with stage III or metastatic NSCLC who may benefit from first-line treatment with Keytruda.

FDA Approves Qiagen Companion Dx for Bladder Cancer Drug Balversa

Qiagen's test is intended to identify advanced bladder cancer patients with alterations in FGFR3 or FGFR2 genes and who are likely to respond to erdafitinib.