Please login to the form below

Not currently logged in
Email:
Password:

Pfizer’s first-in-class breast cancer therapy wins EU licence

Ibrance given the green light as a first-line treatment in Europe
EU

The European Commission has granted Pfizer's first-line breast cancer drug Ibrance marketing authorisation in Europe, making it the first new medicine to get to market in this setting in nearly 10 years.

The first-in-class treatment was awarded Promising Innovative Medicine designation by the Medicines and Healthcare products Regulatory Agency (MHRA) in January last year, and shortly afterwards won FDA approval through its accelerated approval programme.

An oral treatment option, Ibrance (palbociclib) has now been licensed in combination with endocrine therapy to treat hormone receptor positive, HER2-negative, locally advanced metastatic breast cancer.

The CDK 4/6 inhibitor is designed to impede tumour cell growth and delay progression, and the drug has demonstrated significant improvements in efficacy beyond the standard care in the phase II PALOMA-1 and phase III PALOMA-2 and -3 trials.

It increased progression-free survival from 14.5 months to 24.8 months when combined with Novartis' Femara (letrozole) compared to Femara alone, and from 4.6 months to 9.5 months when combined with AstraZeneca's Faslodex (fulvestrant) compared to Faslodex alone.

The studies also showed a significant improvement in patients' quality of life when taking Ibrance in comparison with Faslodex.

David Montgomery, oncology medical director at Pfizer UK, said: “Today's decision to grant marketing authorisation for palbociclib in combination with endocrine therapy is good news for patients.

“However, we have real concerns that this treatment will not be made available by NICE to eligible patients in England and Wales on the NHS.”

A number of metastatic breast cancer treatments have been rejected by the UK cost-effectiveness watchdog over the last few years, including GlaxoSmithKline's Tyverb (lapatinib) and Roche's Herceptin (trastuzumab), Avastin (bevacizumab) and Xeloda (capecitabine).

Montgomery added: “NICE and the NHS need to take a pragmatic approach, showing more willingness to invest in transformative treatments like palbociclib.

“We are committed to finding a solution, but while these system challenges remain, patients in England and Wales most in need of alternative options will be denied this new treatment.”

Article by
Rebecca Clifford

10th November 2016

From: Regulatory

Share

Tags

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
M3 (EU)

M3 has over 20 years’ experience in building online doctor communities. M3 is the world’s largest network of verified doctors...

Latest intelligence

When is an agency not an agency?
The PR Week UK Top 150 Consultancies prompts anticipation and curiosity. But can a virtual collective of freelancers fairly be compared and ranked against conventional agencies?...
Why big pharma needs to be braver
The last few years have seen the pharmaceutical industry undergo a rapid metamorphosis in the face of unprecedented change, but communications are one area that still needs an injection of...
Leveraging Real-World Evidence for Cell and Gene Therapies
Regulators and reimbursement bodies are increasingly turning to real-world evidence (RWE) to understand the long-term value of drugs, in particular novel therapies. Here, Mariam Bibi, Senior Director, Global RWE at...