The results of the PALOMA-2 (phase III) trial show that palbociclib, in combination with letrozole, increased Progression Free Survival – the time it took for the patient’s disease to progress – by just over 10 months, from 14.5 months (on letrozole alone) to 24.8 months. Overall survival data is not yet available.

With no breast cancer drugs being approved by NICE in the last seven years, Breast Cancer Now is not optimistic that palbociclib will be made available to women in the UK when it comes to be appraised in the future.

Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, said:

“These important results provide further evidence of the significant potential of this first-in-class drug for metastatic breast cancer.

“The study shows that palbociclib stops patients’ breast cancers progressing for an extra ten months on average compared to current treatments, time that could be truly invaluable to patients.

“Palbociclib aims to stop cancer cells multiplying out of control by targeting two of the crucial proteins involved. This innovative approach does have side-effects, such as a possible drop in white blood cells, and these will need to be carefully managed if the promise of palbociclib is to be realised.

“Despite it being approved and even fast-tracked by the FDA for use in the United States, this drug will face a number of hurdles in the UK. We haven’t seen a single example of the current NICE appraisal system working for new breast cancer drugs in the last seven years and, without reform, we’re not any more optimistic for palbociclib.

“If it were to be appraised now, our system would compare it to an existing and cheap generic medicine, despite it being the first drug of its kind. As such, while it could offer considerable progression-free time to women living with metastatic cancer, it would be near-impossible for this new patented drug to show it can be cost-effective.”

More information

Read more on the Guardian  and BBC News