Pfizer’s new cancer drug Ibrance has cleared the initial barrier to joining the UK’s Early Access to Medicines Scheme after being honored ‘Promising Innovative Medicine’ reputation by the UK regulatory authority, Medicines and Healthcare Regulatory Agency (MHRA).
Ibrance (palbociclib) is being developed as a therapy for the breast cancer for patients with tumors that are estrogen-receptor-positive but HER2-negative.
According to Mace Rothenberg, chief medical officer at Pfizer Oncology
European regulators are presently examining the drug based on data from the PALOMA-1 and PALOMA-3 clinical trials, which confirmed “major clinical benefit” for women with the condition taking Ibrance together with endocrine therapy.
PALOMA-1 revealed first-line therapy with the Ibrance /letrozole combination enhanced progression-free survival by about 50% in comparison to letrozole alone.
The industry backed Early Access to Medicines Scheme is developed to offer patients with life threatening conditions much quicker access to innovative and promising new medicines, even before the medicine has obtained full regulatory acceptance after the MHRA has signalled that the benefits outweigh the risks.
PIM designation is the initial step in the process, the next is getting an EAMS Scientific Viewpoint from the MHRA, if the quality, safety and efficacy data offered in support of the application are adequate to support a favourable benefit/risk balance and added clinical value.