Palbociclib
Palbociclib was the first CDK4/6 inhibitor (2015), and in 2026 became the first approved as maintenance in HER2-positive, hormone-positive breast cancer.
PALOMA-2/3 (PFS benefit, no OS benefit); PALLAS and PENELOPE-B negative in adjuvant setting. PATINA (2024 SABCS; approved Q2 2026): adding palbociclib to anti-HER2 plus endocrine maintenance in HR+/HER2+ metastatic disease extended PFS by ~15 months. Pfizer.
1.Oral drug is absorbed and reaches the tumour
- Route
- Oral
- Schedule
- 125 mg once daily for 21 days, then 7 days off (28-day cycle), with aromatase inhibitor or fulvestrant
- Dose modifications
- Reduce to 100 then 75 mg for grade 3 neutropenia with fever or grade 4
- Monitoring
- Complete blood count before each cycle and on day 15 of the first two cycles; ILD symptoms
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- Medicare
- Part D (self-administered)
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026). Ibrance was selected for Medicare price negotiation in January 2025; the negotiated price takes effect 1 January 2027.
- Commercial insurance
- covered with prior authorisation
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. Some PBMs designate a preferred CDK4/6 inhibitor and require it first.
- Assistance programmes
- Pfizer Oncology Together
- Pfizer RxPathways
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap) · CMS: Medicare Drug Price Negotiation Program. Not medical or financial advice; verify with your plan.
- Appraised for
- With an aromatase inhibitor for untreated HR-positive, HER2-negative advanced breast cancer
- Notes
- With fulvestrant after endocrine therapy: TA619 (2020, from CDF to routine).
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA495 · SMC advice: palbociclib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 3 Feb 2015ApprovalUS
Accelerated approval with letrozole: first CDK4/6 inhibitor (PALOMA-1) source
- 19 Feb 2016ApprovalUS
With fulvestrant after endocrine therapy (PALOMA-3) source
- 31 Mar 2017ApprovalUS
Full approval (PALOMA-2) source
- 4 Apr 2019ApprovalUS
Men with HR+/HER2- breast cancer source
- Q2 2026ApprovalUS
Maintenance in HR+/HER2+ advanced breast cancer with anti-HER2 and endocrine therapy (PATINA) source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2015 | HR+/HER2- advanced breast cancer with endocrine therapy |
| US | 2026 | HR+/HER2+ advanced breast cancer maintenance with anti-HER2 and endocrine therapy |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Neutropenia | 80% | 66% |
| Infections | 60% | 7% |
| Leukopenia | 39% | 25% |
| Fatigue | 37% | 2% |
| Nausea | 35% | 1% |
| Alopecia | 33% | — |
| Stomatitis | 30% | 1% |
| Diarrhoea | 26% | 1% |
| Anaemia | 24% | 6% |
| Rash | 18% | 1% |
PALOMA-2 with letrozole. Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part D; generic entry expected 2027 in the US | not disclosed | pfizeroncologytogether.com |
| United Kingdom | NICE: recommended with aromatase inhibitor (TA495) and fulvestrant (TA619) | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
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Latest papers
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