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33722811000001109

New Medicines

IbranceHR-positive, HER2-negative locally advanced or metastatic breast cancer - tablet formulation

Information

Ibrance
New formulation
Pfizer
Pfizer

Development and Regulatory status

Launched
Approved (Licensed)
Launched
January 2021
Jan 21Available in UK. Price for 75mg, 100mg and 125mg tablets, 21=£2,950,00; 63=£8,850.00 [4].
Dec 20In the US at launch, the cost for the tablet formulation was the same as the capsules [2].
Oct 20New tablet formulation of Ibrance approved in the EU for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer, in combination with an aromatase inhibitor, or in combination with fulvestrant in women who have received prior endocrine therapy. Available in the three strengths (75mg, 100mg and 125mg), identical to the currently available capsule strengths [1].
Apr 20Ibrance tablets available in the US. The formulations of IBRANCE are bioequivalent and contain the same active ingredient [2].
Nov 19New tablet formulation of Ibrance approved in the US. Available in the three strengths (75mg, 100mg and 125mg), identical to the currently available capsule strengths [3].

Category

A highly selective, reversible inhibitor of cyclin-dependent kinases (CDK) 4 and 6. Cyclin D1 and CDK4/6 are downstream of multiple signalling pathways which lead to cellular proliferation.
The incidence of BC in the UK is about 80 per 100,000 people. About 40% develop metastatic disease; 25% of these are HER2-positive.
HR-positive, HER2-negative locally advanced or metastatic breast cancer - tablet formulation
Oral

Trial or other data

Dec 20Pfizer states that, unlike the capsule formulation, the tablet formulation offers patients increased flexibility (patients can take IBRANCE tablets with or without food, and they can be co-administered with proton pump inhibitors or antacids vs. capsules which must be taken with food), dose tracking (tablets come in weekly blister packs that are designed to help patients track their treatment cycles vs. capsules in bottles) and the tablet formulation does not contain lactose (dairy) or gelatin [2].

IbranceHER2-positive, hormone receptor-positive breast cancer - first- or second-line in combination with trastuzumab

Information

Ibrance
Licence extension / variation
Pfizer
Pfizer

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

Pyridopyrimidine-derived cyclin-dependent kinase (CDK) 4 & 6 inhibitor.
The incidence of BC in the UK is about 80 per 100,000 people. About 40% develop metastatic disease; 25% of these are HER2-positive.
HER2-positive, hormone receptor-positive breast cancer - first- or second-line in combination with trastuzumab
Oral

IbranceEarly breast cancer - adjuvant therapy in intermediate risk patients

Information

Ibrance
Licence extension / variation
Pfizer
Pfizer

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Jul 20Development discontinued [7].

Category

Pyridopyrimidine-derived cyclin-dependent kinase (CDK) 4 & 6 inhibitor.
The incidence of BC in the UK is about 80 per 100,000 people. About 40% develop metastatic disease; 75% of these are HER2-negative.
Early breast cancer - adjuvant therapy in intermediate risk patients
Oral

Trial or other data

Jun 20Following a pre-planned efficacy and futility analysis of data, an independent Data Monitoring Committee has concluded that PIII PALLAS study is unlikely to show a statistically significant improvement in the primary endpoint of invasive disease-free survival [6].

IbranceBreast cancer in patients at high risk of recurrence post-neoadjuvant therapy

Information

Ibrance
Licence extension / variation
Pfizer
Pfizer

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Oct 20Development discontinued [10].

Category

Cyclin-dependent kinase (CDK) 4/6 inhibitor
The incidence of BC in the UK is about 80 per 100,000 people. About 40% develop metastatic disease.
Breast cancer in patients at high risk of recurrence post-neoadjuvant therapy
Oral

Further information

Yes
To be confirmed

Trial or other data

Oct 20PIII PENELOPE-B study failed to meet primary endpoint (improvement to invasive disease-free survival). Subgroup analyses are planned to continue [9].