Vivek Subbiah, Chief of Early-Phase Drug Development at the Sarah Cannon Research Institute, shared on LinkedIn:
“Hot off the press
Nature Reviews Clinical Oncology
Pleased to share our new commentary on Daraxonrasib FDA label. Razelle Kurzrock and I love the new Daraxonrasib approval FDA label, and we explain why.
‘An imprecise label in the era of precision medicine: labelling and access for daraxonrasib, the first pan-RAS inhibitor approval’
The FDA recently approved daraxonrasib for patients with metastatic pancreatic adenocarcinoma who received at least one prior systemic therapy, OR who are not candidates for multiagent systemic therapy. Critics have called that second clause non-evidence-based. We see it differently.
Clinical trials generally enroll only patients with good performance status. That does not reflect reality for most people with metastatic pancreatic cancer. Many never reach second-line therapy because their clinical condition deteriorates first. A label written strictly around trial eligibility would leave these patients with nothing.
Here, the imprecision enables access. It lets physicians offer an effective RAS-targeted drug to the patients who need it most, at the point in their illness when it can still help. Real-world evidence should resolve any remaining uncertainty.
Precision medicine should mean the right drug reaching the right patient, not a label that excludes the sickest among them.
Thanks to the editorial leadership of Diana Romero to get this patient-centric commentary published in record time.”
Title: An imprecise label in the era of precision medicine: labelling and access for daraxonrasib, the first pan-RAS inhibitor approval
Authors: Vivek Subbiah, Razelle Kurzrock
Read the Full Article.
You can also read: FDA Grants Breakthrough Therapy Designation to Daraxonrasib Plus Chemotherapy in First-Line Metastatic Pancreatic Cancer
