Pfizer UK’s Ibrance has cleared the first hurdle to joining the UK’s Early Access to Medicines Scheme after being awarded ‘Promising Innovative Medicine’ status by the Medicines and Healthcare Regulatory Agency.
Ibrance (palbociclib) is being developed as a treatment for hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced/metastatic breast cancer.
European regulators are currently reviewing the drug based on data from the PALOMA-1 and PALOMA-3 trials, which demonstrated “significant clinical benefit” for women with the disease taking Ibrance alongside endocrine therapy, according to Mace Rothenberg, chief medical officer at Pfizer Oncology.
PALOMA-1 showed first-line treatment with the Ibrance/letrozole combination boosted progression-free survival by around 50% compared to letrozole alone (20.2 months versus 10.2 months, respectively).
The industry-funded Early Access to Medicines Scheme is designed to provide patients with life-threatening and seriously debilitating conditions much faster access to innovative and promising new drugs, before they have received full regulatory approval, as soon as the MHRA has signalled that the benefits outweigh the risks.
PIM designation is the first stage in the process, the second is attaining an EAMS Scientific Opinion from the MHRA, if the quality, safety and efficacy data provided in support of the application is sufficient to support a positive benefit/risk balance and added clinical value.
