Ibrance

Treats hormone receptor (HR)-positive, human epidermal growth … metastatic breast cancer. NDA 212436, held by Pfizer. Palbociclib.

As of Nov 13, 2026, NDA 212436 (Ibrance), held by Pfizer, was first approved by FDA on Nov 1, 2019, with 8 approved supplements and 0 published complete response letters.

First approved: Nov 1, 2019
Review: Standard
Supplements approved: 8
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 9 submissions below

Date	Submission	Status	Documents
Jun 24, 2026	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 16, 2025	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 23, 2025	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 6, 2023	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 13, 2022	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 1, 2019	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

3 strengths and forms

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

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 24, 2026	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 16, 2025	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 23, 2025	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 6, 2025	Supplement 9Labeling · Standard review	Approved	Label Letter
Dec 20, 2024	Supplement 10Labeling · Standard review	Approved	Label Letter
Sep 6, 2023	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 6, 2023	Supplement 6Labeling · Standard review	Approved	Letter Label
Dec 13, 2022	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 1, 2019	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 212436
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