The European Commission will now consider CHMP's opinion and decide whether to approve the regimen as a first-line option for metastatic NSCLC patients without EGFR or ALK alterations.
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 draft guidelines have intrigued industry players interested in pursuing labeling that would allow their CDx to direct treatment for a class of drugs instead of one drug.
The agency issued draft guidance on minimal residual disease as a biomarker and finalized another guidance on developing drugs with pan-cancer indications.
An Oregon Health Authority committee issued a draft guidance to not cover NGS testing for solid tumors, which advocacy groups say will limit access to Medicaid beneficiaries.
Stakeholder input on FDA's draft Rx/Dx codevelopment guidance signals that precision medicine is actually developed differently than the agency wants it to be.
