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FDA drug approval summary: panitumumab (Vectibix)
Ruthann M Giusti1, Kaushikkumar A Shastri, Martin H Cohen
1Office of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993, USA. ruthann.giusti@fda.hhs.gov
The Oncologist
|May 25, 2007
Summary
Panitumumab significantly improved progression-free survival in patients with metastatic colorectal cancer when added to best supportive care. This treatment demonstrated efficacy in patients who progressed on prior chemotherapy regimens.
Area of Science:
- Oncology
- Pharmacology
Background:
- Metastatic colorectal carcinoma (mCRC) poses a significant treatment challenge, particularly after failure of standard chemotherapy.
- Epidermal growth factor receptor (EGFR) is a validated target in mCRC treatment.
Purpose of the Study:
- To evaluate the efficacy and safety of panitumumab in patients with EGFR-expressing metastatic colorectal cancer who progressed on prior chemotherapy.
- To determine the impact of panitumumab on progression-free survival (PFS).
Main Methods:
- A randomized, multinational, open-label study enrolled 463 patients with EGFR-expressing mCRC.
- Patients received either best supportive care (BSC) alone or BSC plus panitumumab (6 mg/kg intravenously every other week).
- Progression-free survival (PFS) was the primary endpoint, assessed by an independent, blinded review committee.
Main Results:
- Panitumumab plus BSC significantly prolonged median PFS (56 days) compared to BSC alone (51 days).
- Partial responses were observed in 8% of panitumumab-treated patients, with a median response duration of 17 weeks.
- No significant difference in overall survival was observed between the treatment arms.
Conclusions:
- Panitumumab is an effective treatment option for patients with EGFR-expressing metastatic colorectal cancer who have progressed on standard chemotherapy.
- The addition of panitumumab to BSC improves PFS in this patient population.
- Common adverse events include skin rash and gastrointestinal issues; serious events require careful monitoring.
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