Ibrance

Treats hormone receptor (HR)-positive, human epidermal growth … metastatic breast cancer. NDA 207103, held by Pfizer. Palbociclib.

As of Nov 13, 2026, NDA 207103 (Ibrance), held by Pfizer, was first approved by FDA on Feb 3, 2015, with 16 approved supplements and 0 published complete response letters.

First approved: Feb 3, 2015
Review: Priority
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

IBRANCE is a kinase inhibitor indicated:

for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: o an aromatase inhibitor as initial endocrine-based therapy; or o fulvestrant in patients with disease progression following endocrine therapy.
in combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA -mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-authorized test, following recurrence on or after completing adjuvant endocrine therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Jun 24, 2026	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 16, 2025	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 23, 2025	Supplement 20Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 6, 2023	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 13, 2022	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 9, 2019	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 4, 2019	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Feb 6, 2018	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 31, 2017	Supplement 4Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Feb 19, 2016	Supplement 2Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Feb 3, 2015	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Letter Label

Products

3 strengths and forms

Product	Active ingredient	Marketing
Ibrance75MG · capsule;oral	Palbociclib	RxReference drug
Ibrance100MG · capsule;oral	Palbociclib	RxReference drug
Ibrance125MG · capsule;oral	Palbociclib	RxReference drug

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 24, 2026	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 16, 2025	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 23, 2025	Supplement 20Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 6, 2025	Supplement 21Labeling · Standard review	Approved	Label Letter
Dec 20, 2024	Supplement 22Labeling · Standard review	Approved	Label Letter
Sep 6, 2023	Supplement 18Labeling · Standard review	Approved	Letter Label
Sep 6, 2023	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 13, 2022	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 9, 2019	Supplement 12Labeling	Approved	Label Letter
Sep 9, 2019	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 4, 2019	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Feb 19, 2019	Supplement 10Labeling · Standard review	Approved	Letter Label
Feb 6, 2018	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 31, 2017	Supplement 4Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Feb 19, 2016	Supplement 2Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Dec 17, 2015	Supplement 1Manufacturing · Priority review	Approved	None posted
Feb 3, 2015	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 207103
Drugs@FDA: Overview at FDA
Company: Pfizer

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