"These findings are very exciting because until now, most ALK+ NSCLC patients experience disease progression within less than a year of treatment with an ALK inhibitor," said lead investigator Enriqueta Felip, MD, PhD, Vall d'Hebron University. "This is the longest median progression-free survival data we've seen in this broad patient population and it is even more striking when you consider that most of them have received up to three rounds of chemotherapy before taking ceritinib as their first ALK inhibitor."
"The median overall survival of 44 months for everolimus is unprecedented in controlled clinical trials for advanced progressive pancreatic neuroendocrine tumors," said James Yao*, MD, lead investigator, The University of Texas MD Anderson Cancer Center, Houston, Texas. "The results affirm the importance of targeting key pathways involved in tumor growth, such as the mTOR pathway in advanced pNET."
"This positive CHMP opinion for Signifor LAR formulation represents a significant step towards our goal of being able to offer adult patients with inadequately controlled acromegaly in the EU a much-needed alternative treatment option," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. "Our continued investment in acromegaly research reflects the strong commitment Novartis has to the pituitary community as we work to help address unmet medical needs and ensure that patients receive the best therapeutic options for individualized care."
"The PANORAMA-1 study is the first Phase III trial to show the superiority of LBH589 plus bortezomib and dexamethasone over one of the standard two-drug regimens for patients with relapsing and/or refractory multiple myeloma," said lead study investigator Jesus San-Miguel, MD, Director of Clinical and Translational Medicine, Clínica Universidad de Navarra, Pamplona, Spain. "These results show that by adding a new mechanism of action, pan-DAC inhibition, there is a significant benefit for this patient population."
"At ESMO 2014 we will present new data on key compounds that demonstrate the breadth of the biological markers we target," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. "By understanding what drives different cancers to develop and grow, our clinical program has led to the development of precise therapies for patients with the specific genetic profile targeted by these treatments, enabling us to make a difference for people living with these diseases."
"This Breakthrough Therapy designation underscores the potential of CTL019 as a life-saving therapy for patients with relapsed/refractory ALL, who are in desperate need of new treatment options," said David Epstein, Division Head, Novartis Pharmaceuticals. "Novartis welcomes increased dialogue with the FDA and a potentially expedited review to streamline the development of CTL019 and hopefully bring this promising therapy to patients as quickly as possible."