IBRANCE

What it is

IBRANCE contains palbociclib. IBRANCE is available as capsules or film-coated tablets in strengths of 75 mg, 100 mg or 125 mg. IBRANCE is supplied as hard capsules or film-coated tablets for oral administration. Palbociclib is a first-in-class CDK4/6 inhibitor that prevents cellular proliferation by inhibiting G1 to S phase progression of the cell cycle.

Approved indications

IBRANCE is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: — an aromatase inhibitor as initial endocrine-based therapy — fulvestrant in patients who have received prior therapy

Dosing overview

The recommended dose of IBRANCE is a 125 mg capsule or tablet taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. IBRANCE capsules should be taken with food. IBRANCE tablets may be taken with or without food. IBRANCE capsules or tablets should be swallowed whole (do not chew, crush, open the capsules or split the tablets prior to swallowing). No dose adjustment is required for patients with mild or moderate hepatic impairment (Child-Pugh classes A and B). For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg once daily for 21 consecutive days followed by 7 days off treatment.

Key safety warnings

Neutropenia has been observed very commonly in clinical studies with IBRANCE. In patients receiving IBRANCE in combination with letrozole and in combination with fulvestrant, Grade 3 and Grade 4 decreased neutrophil counts were reported in 56.1% and 10.6% of patients respectively. Full blood count should be monitored prior to the start of IBRANCE therapy and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated. Dosing interruption, dose reduction or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia. Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with CDK4/6 inhibitors, including IBRANCE when taken in combination with endocrine therapy. In patients receiving IBRANCE in combination with letrozole and in combination with fulvestrant, ILD was reported in 1.7% and 1.4% of patients, respectively. Across the clinical trials 0.1% had Grade 3, and no Grade 4 or fatal cases were reported. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported. Since IBRANCE has myelosuppressive properties, it may predispose to infections. Infections of any grade have been reported at a higher rate in patients treated with IBRANCE. Infections of any grade occurred in 63.6% of patients treated with IBRANCE and letrozole compared to 42.8% of patients treated in the comparator arm. Infections of any grade occurred in 55.1% of patients treated with IBRANCE and fulvestrant, compared to 36.0% of patients treated in the comparator arm.

Contraindications

Use of IBRANCE is contraindicated in patients with hypersensitivity to palbociclib or to any of the excipients.

PBS listing

IBRANCE tablets in strengths of 75 mg, 100 mg and 125 mg are each listed on the PBS with authority required restriction. The ex-manufacturer price for each strength is A$3495.12.

Regulatory history

IBRANCE palbociclib capsules in strengths of 75 mg, 100 mg and 125 mg were first listed on the Australian Register of Therapeutic Goods on 3 May 2017. IBRANCE palbociclib tablets in strengths of 75 mg, 100 mg and 125 mg were first listed on the ARTG on 16 June 2020. In November 2017, the Pharmaceutical Benefits Scheme Advisory Committee recommended IBRANCE for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant. In March 2018, IBRANCE was listed on the PBS with authority required restriction in combination with non-steroidal aromatase inhibitors, with reduced effective price and financial caps applied. In March 2022, the PBAC recommended IBRANCE for locally advanced (stage IIIB/IIIC) or metastatic (stage IV) HR-positive, HER2-negative breast cancer in patients who have received previous endocrine therapy, in combination with fulvestrant.