Vectibix

Treats KRAS G12C- mutated mCRC. BLA 125147, held by Amgen. Panitumumab.

As of Nov 14, 2026, BLA 125147 (Vectibix), held by Amgen, was first approved by FDA on Sep 27, 2006, with 18 approved supplements and 0 published complete response letters.

First approved: Sep 27, 2006
Review: Standard
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Vectibix is an epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of: Adult patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test) Metastatic Colorectal Cancer (mCRC)*: In combination with FOLFOX for first-line treatment. ( 1, 14.2 ) As monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy. ( 1, 14.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


Jan 16, 2025	Supplement 213Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jun 29, 2017	Supplement 207Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 23, 2014	Supplement 108Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 23, 2014	Supplement 186Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 23, 2008	Supplement 26Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 27, 2006	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

3 strengths and forms


Vectibix5ML/100MG · injectable; iv (infusion)	Panitumumab	Rx
Vectibix10ML/200MG · injectable; iv (infusion)	Panitumumab	Rx
Vectibix20ML/400MG · injectable; iv (infusion)	Panitumumab	Rx

All 19 submissions, including labeling and manufacturing supplements


Jan 16, 2025	Supplement 213Efficacy (new indication or use) · Priority review	Approved	Label Letter
Aug 25, 2021	Supplement 210Labeling · Standard review	Approved	Label Letter
Jun 29, 2017	Supplement 207Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 11, 2015	Supplement 200Labeling · Standard review	Approved	Letter Label
Aug 30, 2014	Supplement 194Labeling · Standard review	Approved	Letter Label
May 23, 2014	Supplement 108Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 23, 2014	Supplement 186Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 28, 2013	Supplement 169Labeling · Standard review	Approved	Letter Label
Aug 17, 2012	Supplement 148Labeling · Standard review	Approved	Letter Label
Aug 17, 2012	Supplement 152Labeling · Standard review	Approved	Letter
Dec 12, 2011	Supplement 137Labeling · Standard review	Approved	None posted
Mar 15, 2011	Supplement 123Labeling · Standard review	Approved	None posted
May 26, 2010	Supplement 103Labeling · Standard review	Approved	None posted
Jul 17, 2009	Supplement 78Labeling · Standard review	Approved	None posted
Jul 17, 2009	Supplement 80Labeling · Standard review	Approved	Label
Apr 27, 2009	Supplement 67Labeling · Standard review	Approved	Letter Label
Jun 23, 2008	Supplement 26Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 6, 2007	Supplement 18Labeling · Standard review	Approved	Label Letter
Sep 27, 2006	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: BLA 125147
Drugs@FDA: Overview at FDA
Company: Amgen

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters