Physician Views: Pfizer Delivered Regulatory Promise With Ibrance, Can It Deliver A Strong Launch?
While much of the focus at Pfizer continues to be sharpened on M&A activity, recent approval of Ibrance (palbociclib) for the first-line treatment of ER+/HER2- breast cancer may have been overlooked in some quarters.
It should not be. Ibrance not only represents one of the most commercially promising drugs to emerge from Pfizer's R&D pipeline in recent years, but approval on the strength of Phase II data, and some two months ahead of its April PDUFA date, has vindicated the company's bullish stance on delivering the drug to market (ViewPoints: Pfizer sets out – earlier than expected – to show value of pipeline via Ibrance).
Investors had run hot and cold on the prospect of Pfizer successfully gaining approval for Ibrance ahead of Phase III data (with the relevant PALOMA-2 study expected to complete by year-end) and when FirstWord polled oncologists back in August, respondents were split fairly evenly as to whether they thought Phase II results were sufficient to support regulatory clearance.
A key question is whether this reticence will curb uptake of Ibrance until Phase III data – and a demonstrated overall survival benefit – are available. Positively for Pfizer and breast cancer patients, key opinion leaders (KOLs) interviewed by FirstWord's Therapy Trends team on a number of occasions during the second half of last year grew increasingly upbeat about the chances of approval and their usage of the drug. A number of KOLs who had used Ibrance first hand were extremely positive about the product and the progression-free survival benefit (PFS) when used in combination with the aromatase inhibitor letrozole versus letrozole alone (20.2 month versus 10.2 months).
Indeed, a consistent message from KOLs was whether FDA labelling would be vague enough to either utilise the Ibrance/letrozole combination in pre-treated metastatic patients or with an alternative aromatase inhibitor to letrozole in patents already treated with this drug in the adjuvant setting.
Reasons to Purchase
With approval now secured in the US and with the FDA having given Ibrance considerable regulatory backing (the drug was both granted breakthrough therapy and priority review status), we are polling US-based oncologists to ascertain how they expect to use the drug over the next 12 months during its initial launch phase. Specifically we are asking them…
How clinically meaningful do you perceive the PFS data for Ibrance to be in the first-line ER+/HER2- breast cancer indication?
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