ICORG Press Release - 15th April 2013

Press Release

ICORG proud to play an important role in the development of a
Significant new cancer medicine – Palbociclib

On 10th April 2013 ICORG (http://www.icorg.ie) the national cancer clinical research organisation, was excited to hear that a compound – palbociclib – which it has played a key role in developing has received breakthrough therapy designation from the Food and Drug Administration (FDA) for the treatment of advanced/metastatic breast cancer. This news is made all the more exciting by the fact that this drug will also be available in Ireland in a matter of weeks at cancer-treating units all over the country through two new ICORG breast cancer clinical trials.

The preliminary trials reviewed by the FDA in order to make its assessment included the disease responses of many Irish patients who agreed to participate in ICORG studies of palbociclib in 2011 and 2012. These studies were led in Ireland by Dr Janice Walshe and by Prof John Crown, who was a senior author for ICORG on the publication of the preliminary data at the main US breast cancer meeting in San Antonio Texas in December of 2012. The study was designed by Dr Denis Slamon and led in the US by Dr Richard Finn both of UCLA.

Dr Finn reported that in the phase 2 study, patients who received the current standard of care medications remained disease-free for an average of 7.5 months, whereas for those who received standard of care plus palbociclib this increased to 26.1 months.

ICORG is encouraged to hear that an agency as experienced in cancer drug development as the FDA has granted this special status to a medicine with which the group is so widely involved. We look forward to the phase 3 studies confirming the findings of the early trials.

The FDA is the agency which approves new medicines on behalf of the US government and has the highest volume of applications of any agency in the world every year. Its independent experts review clinical trial data submitted by pharmaceutical companies and decide whether the data supports a claim for a new medicine. The agency also acts in an advisory capacity by engaging with companies who are planning and designing clinical trials and advising on ways to prove that a new medicine is equivalent to or better than what is currently standard of care.

In 2013 the FDA created a new designation of ‘breakthrough therapy’ for medicines in development deemed likely to demonstrate substantial improvement over existing treatments. This is reserved for a small number of medicines for which the early data from phase 1 and phase 2 trials is considered to be particularly ground-breaking.

ICORG would like to thank Pfizer Ireland, the drug manufacturer and TRIO Inc. the international research collaborator for their assistance in helping to bring these pivotal clinical trials to Ireland.

Contact: Prof John Crown or ICORG @ (01) 6677211

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