- Trial Phase
- Approved / Marketed
- Time to Market
- Already approved and commercially available since 2006. The January 2025 label expansion for the KRAS G12C combination is the most recent approval.
- Why 4/10
- Vectibix is an already-approved, marketed drug with no pending PDUFA date, FDA Advisory Committee, or pivotal topline readout scheduled in the next ~12 months. The impactScore of 4 reflects that it is a commercial-stage product without a hard binary catalyst; it contributes meaningful revenue (~$1.2B/year) to a large-cap biotech with a broad pipeline, so no single drug drives a make-or-break outcome.
Vectibix is a mature, approved product with no upcoming PDUFA or pivotal readout. The FDA warning letter (Oct 27, 2026) over a promotional video is a compliance issue Amgen says stemmed from an inadvertent submission of an undisseminated file; it is unlikely to materially affect sales. Watch quarterly revenue trends for volume growth trajectory and any label-expansion data from ongoing PARADIGM/PRIME studies, though none are near-term binary catalysts.
Price Chart
Executive Summary
Vectibix (panitumumab) is Amgen's fully human monoclonal antibody that blocks EGFR, approved by the FDA in 2006 for metastatic colorectal cancer (mCRC). It is indicated for wild-type RAS mCRC as monotherapy or with FOLFOX chemotherapy, and since January 2025 in combination with Amgen's Lumakras (sotorasib) for KRAS G12C-mutated mCRC. Vectibix is the #1 prescribed anti-EGFR in mCRC and generated ~$1.2 billion in 2025 revenue, with Q3 2026 sales of $335 million (+18% YoY) driven by volume growth. In late October 2026, the FDA issued a warning letter over a promotional video that omitted risk information; Amgen said the incorrect file was inadvertently submitted and never publicly disseminated. As a mature commercial product with no pending regulatory decision, Vectibix is a steady growth contributor within Amgen's broad portfolio rather than a binary catalyst for the stock.
How It Works
Vectibix is a lab-made antibody (a type of protein) that targets and blocks the epidermal growth factor receptor (EGFR), a protein on the surface of some cancer cells that helps them grow and divide. By blocking EGFR, Vectibix slows or stops the growth of certain colorectal cancers. It is given as an intravenous infusion.
Trial Status
Vectibix was originally approved by the FDA in September 2006. The current label covers wild-type RAS mCRC (monotherapy and first-line with FOLFOX) based on the PRIME and PARADIGM Phase 3 trials. In January 2025, the FDA approved the combination of sotorasib + Vectibix for KRAS G12C-mutated mCRC based on the CodeBreaK 300 Phase 3 study. Ongoing research includes real-world evidence and post-hoc analyses from PARADIGM.
The Two-Sided Case
Upcoming Catalysts
- No upcoming PDUFA dates, FDA Advisory Committee meetings, or pivotal topline readouts are scheduled for Vectibix in the next ~12 months.
- Quarterly earnings reports will continue to show Vectibix revenue trends (next: Q4 2026 in early February 2027).
- Any future label-expansion data from ongoing studies (e.g., PARADIGM subgroup analyses) could incrementally support prescribing, but none represent a hard binary catalyst.
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Amgen PRESS-RELEASE AMGN ·Originating report