Perjeta

Treats HER2-positive metastatic breast cancer (MBC). BLA 125409, held by Genentech. Pertuzumab.

As of Nov 13, 2026, BLA 125409 (Perjeta), held by Genentech, was first approved by FDA on Jun 8, 2012, with 13 approved supplements and 0 published complete response letters.

First approved: Jun 8, 2012
Review: Priority
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

PERJETA is a HER2/neu receptor antagonist indicated for: Use in combination with trastuzumab and docetaxel for treatment of adults with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. Use in combination with trastuzumab and chemotherapy as neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. ( 1.2, 2.2, 14.2 ) adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence ( 1.2, 2.2, 14.3 ) 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Apr 23, 2026	Supplement 141Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 16, 2020	Supplement 124Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 20, 2017	Supplement 118Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Dec 20, 2017	Supplement 113Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Mar 17, 2015	Supplement 104Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 30, 2013	Supplement 51Efficacy (new indication or use) · Priority review	Approved	Review Other Summary Review Letter
Apr 12, 2013	Supplement 32Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jun 8, 2012	Original applicationNew molecular entity · Priority review	Approved	Review Other Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Perjeta420MG/14ML · vial; single-use	Pertuzumab	Rx

All 14 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 23, 2026	Supplement 141Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 27, 2025	Supplement 139Labeling · Standard review	Approved	Label Letter
Apr 2, 2025	Supplement 137	Approved	Letter Label
Jan 16, 2020	Supplement 124Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 18, 2018	Supplement 123Labeling · Standard review	Approved	Letter Label
Sep 20, 2018	Supplement 121Labeling · Standard review	Approved	Label Letter
Dec 20, 2017	Supplement 118Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Dec 20, 2017	Supplement 113Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Mar 22, 2016	Supplement 109Labeling · Standard review	Approved	Review Letter Label
May 29, 2015	Supplement 105Labeling · Standard review	Approved	Label Letter
Mar 17, 2015	Supplement 104Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 30, 2013	Supplement 51Efficacy (new indication or use) · Priority review	Approved	Review Other Summary Review Letter
Apr 12, 2013	Supplement 32Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jun 8, 2012	Original applicationNew molecular entity · Priority review	Approved	Review Other Letter Label

Identifiers

Application: BLA 125409
Drugs@FDA: Overview at FDA
Company: Genentech

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