Piciclib® Palbociclib Capsules

Description

Palbociclib is an orally administered, selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6), developed for use in combination with endocrine therapy for the treatment of hormone receptor-positive, HER2-negative breast cancer. CDK4/6 are proteins that regulate cell division. By inhibiting these kinases, palbociclib disrupts the uncontrolled growth of cancer cells, particularly in hormone-sensitive breast cancer types.

Palbociclib is the generic name of Ibrance, a widely recognized brand approved by the U.S. Food and Drug Administration (FDA) in 2015 for advanced breast cancer treatment. It is available in capsule and tablet forms in 75mg, 100mg, and 125mg strengths, making dosage adjustment accessible for personalized treatment plans.

Brand names include:

• US & Canada: Ibrance (Pfizer)

• EU: Ibrance

• UK: Ibrance

• Australia: Ibrance

Indications and On-label Uses

Palbociclib is primarily indicated for:

• Treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in combination with:

  • Letrozole as initial endocrine-based therapy in postmenopausal women or in men.

  • Fulvestrant in patients with disease progression following endocrine therapy.

These indications are supported by multiple Phase 3 trials including PALOMA-2 and PALOMA-3, which demonstrated significant improvements in progression-free survival (PFS) when palbociclib was added to endocrine therapy .

Off-label Uses

Although not FDA-approved for these uses, palbociclib has been explored in clinical trials and case reports for:

• Male breast cancer

• Hormone receptor-positive ovarian cancer

• Non-small cell lung cancer (NSCLC)

• Glioblastoma multiforme

Clinical data for these indications is still evolving, and any off-label use should be supervised by an oncologist with a risk-benefit evaluation .

Mechanism of Action

Palbociclib selectively inhibits CDK4 and CDK6, which are critical for cell cycle progression from G1 to S phase. By blocking these kinases, palbociclib induces cell cycle arrest in RB (retinoblastoma protein)-proficient cells, slowing tumor proliferation. This is especially beneficial in hormone-driven cancers where the RB pathway remains functional.

This targeted approach reduces the need for traditional chemotherapy in select patients, minimizing systemic toxicity while preserving efficacy .

Clinical Efficacy and Trials

In the PALOMA-2 trial, median progression-free survival was 24.8 months with palbociclib plus letrozole, compared to 14.5 months with letrozole alone. Similarly, PALOMA-3 showed that palbociclib plus fulvestrant nearly doubled PFS versus fulvestrant alone in previously treated women .

These results established palbociclib as a gold standard in CDK4/6 inhibition for breast cancer.

Side Effects and Safety Profile

Common side effects include:

• Neutropenia (low white blood cell count)

• Fatigue

• Nausea

• Alopecia (hair thinning)

• Diarrhea

Serious risks include:

• Severe neutropenia requiring dose modification

• Pulmonary embolism

• Liver enzyme elevation

Routine blood count monitoring is recommended, especially during the first two cycles. Safety protocols are in place to manage hematologic toxicity effectively .

Palbociclib Price and Accessibility

The Ibrance cost can range between $10,000 to $15,000 per month in the United States depending on insurance coverage and pharmacy location. However, Ibrance coupons and patient assistance programs are available from the manufacturer and third-party platforms.

For those seeking an affordable alternative, Ibrance generic options—such as palbociclib tablets—offer a lower-cost solution. Global sourcing from regulated international pharmacies provides substantial savings, with palbociclib price dropping by 60–80% compared to U.S. retail rates.

The high cost raises an ongoing question in the oncology field: Why is Ibrance so expensive? The answer lies in its research-backed development, limited generic competition, and patent protections, though this is changing as generics gain global approval .

Dosage and Administration

Palbociclib is typically administered as:

• 125 mg orally once daily for 21 consecutive days followed by 7 days off, in a 28-day cycle.

Doses may be adjusted to 100mg or 75mg in cases of adverse events or patient-specific tolerability. It should be taken with food to improve absorption.

Drug Interactions

Concomitant use with strong CYP3A inhibitors (e.g., ketoconazole) or inducers (e.g., rifampin) should be avoided due to altered palbociclib plasma concentrations. Palbociclib may also impact QT intervals in some patients, necessitating cardiac monitoring in those with preexisting conditions .

FAQs

What is the generic name for Ibrance?
The generic name is palbociclib.

Why is Ibrance so expensive?
Ibrance’s high cost is attributed to patent protection, R&D expenses, and limited market competition. Generics are helping reduce prices in many countries.

Can men use palbociclib?
Yes, it is FDA-approved for use in men with HR+, HER2– metastatic breast cancer.

Is there a generic version of Ibrance?
Yes. Generic palbociclib tablets are available and may offer a lower-cost alternative to the brand.

How much does Ibrance cost per month?
Depending on pharmacy and insurance, the cost can exceed $12,000/month without discounts.

References:

1. PALOMA-2 Clinical Trial – NEJM

2. Off-Label Use in Ovarian Cancer – NCBI

3. CDK4/6 Inhibitors for Non-Breast Cancers – Frontiers in Oncology

4. Mechanism of Action – Pfizer

5. FDA Label – Ibrance (palbociclib)

6. Generic Ibrance Pricing Trends – Drugs.com

7. Drug Interactions – Medscape