Amgen Statement on FDA ODAC Meeting

We thank the FDA for their time, the Oncologic Drugs Advisory Committee for their thoughtful discussion and the patients and advocates for sharing their perspectives.

The CodeBreaK 200 study was a prospective, active-controlled, randomized Phase 3 trial in which LUMAKRAS^® (sotorasib) showed a statistically significant increase in progression-free survival (PFS) and significantly higher objective response rate (ORR) over standard of care chemotherapy, docetaxel, in pretreated patients with KRAS G12C-mutated advanced NSCLC. LUMAKRAS once daily at the 960 mg dose has shown a favorable benefit/risk profile in multiple studies across the CodeBreaK development program. To date, over 15,000 patients worldwide have received LUMAKRAS/LUMYKRAS through the clinical development program, early access and commercial use.

We thank the investigators, patients and their families that participated in CodeBreaK 200. We will continue to progress our comprehensive global KRAS^G12C inhibitor development program exploring multiple LUMAKRAS combination regimens, including in colorectal cancer. We will continue to work closely with the FDA on the full approval pathway for this important medicine.