Role of IBRANCE in MBC

Three category 1 recommendations from the
National Comprehensive Cancer Network® (NCCN®)1
Category 1: Based upon high-level evidence, there is uniform NCCN consensus that both palbociclib (IBRANCE) combination regimens are appropriate interventions.
Palbociclib (IBRANCE)
+ aromatase inhibitor
Palbociclib (IBRANCE)
+ fulvestrant
Palbociclib (IBRANCE) + fulvestrant
Are preferred regimens for the first-line treatment of women
with HR+/HER2- mBC who are postmenopausal or premenopausal
receiving ovarian suppression or ablation1*
Is a preferred regimen for the second- and subsequent-line treatment of women with HR+/HER2- mBC who are postmenopausal or premenopausal receiving ovarian suppression or ablation (if a CDK4/6 inhibitor is not previously used)1*
CDK4/6=cyclin-dependent kinases 4 and 6.
*Aromatase inhibitors and fulvestrant have category 1 recommendations in combination with any CDK4/6 inhibitor.1
If there is disease progression while on CDK4/6 inhibitor therapy, there are limited data to support an additional line of therapy with another CDK4/6-containing regimen.1
The NCCN Guidelines® above fall outside the palbociclib (IBRANCE)
US Prescribing Information.
IBRANCE Indications
IBRANCE 125 mg capsules and tablets are indicated for the treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (mBC) in combination with:
  • an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men, or
  • fulvestrant in patients with disease progression following endocrine therapy
The appropriate use of IBRANCE should be based on a risk/benefit assessment by the practitioner for an individual patient.
Evaluated in a broad range of patients
PALOMA-2:
IBRANCE + letrozole2
First line in mBC
(no prior lines of mBC therapy)
With or without prior (neo)adjuvant
chemotherapy
Postmenopausal women
30-89 years of age (median=62)
Visceral/nonvisceral (including bone-only)
DFI: De novo metastatic, ≤12 months,
>12 months
PALOMA-3:
IBRANCE + fulvestrant3§
First line or later in mBC
(for patients who progressed on or after ET in the
adjuvant or metastatic setting)
Up to 1 prior line of chemotherapy
for mBC
Pre-/peri-/postmenopausal women
30-88 years of age (median=57)
Visceral/nonvisceral (including bone-only)
DFI: ≤24 months, >24 months
DFI=disease-free interval; ER=estrogen receptor; ET=endocrine therapy.
PALOMA-2 was a 2:1 randomized, double-blind, Phase 3 trial of postmenopausal women with ER+/HER2- mBC with no prior treatment in the metastatic setting (N=666). IBRANCE 125 mg PO once daily was taken 3 weeks on, 1 week off + letrozole 2.5 mg PO once daily vs placebo + letrozole.2
§PALOMA-3 was a 2:1 randomized, double-blind, Phase 3 trial of women with HR+/HER2- mBC who progressed on or after endocrine therapy in the adjuvant or metastatic setting (N=521). IBRANCE 125 mg PO once daily was taken 3 weeks on, 1 week off + fulvestrant 500 mg IM on Days 1, 15, 29, and monthly thereafter vs placebo + fulvestrant.3
In-practice experience
Experience with IBRANCE in HR+/HER2- mBC has grown rapidly since its FDA approval in 2015.
5+
YEARS
since initial FDA approval
14,000+
PRESCRIBERS
have chosen IBRANCE4||
115,000+
PATIENTS
prescribed IBRANCE4||
||Estimated data, as of March 2020.4
REFERENCES
1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.4.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed May 8, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
2. Finn RS, Martin M, Rugo HS, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375(20):1925-1936.
3. Turner NC, Ro J, André F, et al; PALOMA3 Study Group. Palbociclib in hormone-receptor-positive advanced breast cancer. N Engl J Med. 2015;373(3):209-219.
4. Data on file. Pfizer Inc., New York, NY.