October 13, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
In an interview posted on the Boston Business Journal, Ariad Pharmaceuticals, Inc. ‘s Harvey Berger claimed that he is “absolutely” secure in his role as CEO at the company. He also specified that there has been “a lot of misinformation” since the recent departure of a director at Ariad.
Since business advisor Robert Whelan decided to step down from the board of directors, a shakeup at the top has been seemingly imminent. However, Berger claims that there is “nothing more to read into this.”
The Strength of Iculsig
Despite the rumors surrounding the staff at Ariad Pharmaceuticals, the company has been moving forward with positive news surrounding its drug, Iculsig, which is designed to treat adult patients with chronic phase, accelerated phase of blast phase chronic myeloid leukemia who are resistant to dasatinib or nilotinib.
On Oct. 10, the company announced that the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency had concluded its review of the drug, also known as ponatinib, under the Article 20 referral procedure. As a result, the agency determined that Iculsig should continue to be used in Europe.
“We are grateful for the rigorous and in-depth review provided by the PRAC and the Scientific Advisory Group for Oncology,” said Berger. “The PRAC recommendation provides insightful guidance to healthcare professionals and patients regarding the use of Iclusig in patients with Ph+ leukemias and importantly, leaves the original Iclusig indication statement unchanged. We look forward to consideration and adoption of these recommendations by the CHMP later this month and authorization by the European Commission by the end of the year.”
In addition to being recommended for the treatment of chronic phase, accelerated phase of blast phase chronic myeloid leukemia, Iclusig has been suggested to those with Philadelphia-chromosome positive acute lymphoblastic leukaemia who are resistant to dasatinib.
“The recommendation from the PRAC confirms a positive benefit-risk assessment for Iclusig after thorough consideration of updated safety information,” said Stephen O’Brien, Professor of Haematology at the Northern Institute for Cancer Research at Newcastle University. “This is a good outcome for patients and healthcare professionals in Europe as it continues to offer a treatment option to CML patients who have become resistant to, or intolerant of, certain other TKIs.”
Iclusig is a kinase inhibitor that is designed to inhibit the activity of BCR-ABL in patients with leukemia.
