The oral MET inhibitor, marketed as Tabrecta, is for patients whose tumors have a mutation that leads to MET exon 14 skipping as detected by a Foundation Medicine test.
The drugmaker will promote Zejula without a biomarker as a first-line maintenance option, and Myriad will highlight that patients with HRD are most likely to benefit.
The firm said the assays detect all classes of alterations including genomic signatures for microsatellite instability, tumor mutation burden, and loss of heterozygosity.
While the guidance may lead to more streamlined CDx indications in precision oncology, test developers will still need to generate evidence, perhaps with limited pharma support.
The FDA approved the drug based on data on response rate but continued approval is contingent on the results of a randomized study showing a PFS and OS advantage.
With TMB as a CDx, the drug will be available to more patients as a salvage option, but doctors will still need to consider the complex biomarker amid evolving research.
The agency recognized that having some companion tests approved for a few but not all cancer drugs with the same molecularly defined indication is not optimal for patient care.
The companies initially plan to validate biomarkers for use with the Oncomine Dx Target Test to identify NSCLC patients for enrollment into clinical trials.
InfanDx is taking the lead on the project and will be joined by researchers from University Hospital Essen, Clinic for Pediatrics I, and Furtwangen University.
Genetron will provide clinical trial genomic testing and companion diagnostic development services for InnoCare's biomarker-driven oncology drug development.
ARUP partnered with BioMarin to develop the blood-based assay, which is intended to identify those patients most likely to respond to the drug firm's AAV5-based gene therapy.
Myriad filed an sPMA for myChoice CDx despite GSK's confidence that Zejula will be approved in newly diagnosed ovarian cancer regardless of biomarker status.
