15.01.2013 - The European Medicines Agency has updated guidelines on cancer drugs in clinical development.
„Convincingly demonstrated favourable effects on overall survival (OS) are from both a clinical and methodological perspective, the most persuasive outcome of a clinical trial“, the London-based Agency writes in its new guidelines that will come into force this July. However, prolonged progression-free or disease-free survival will be, in most cases, be considered relevant measures of patients benefit, but the magnitude of the treatment effect has to be sufficiently large to outbalance toxicity and tolerability problems.
Alongside conventional aims such as defining the proper doses and schedule for a medicine, the guideline highlights the importance of identifying the target population during the development. With regard to the co-development of stratification biomarkers, personalised medicine has become reality. The new guidance document covers the use of biomarkers as an integrated part of drug development. This means that in most cases, hypotheses are to be tested and confirmed with appropriate candidate biomarkers through all phases of clinical development. In cancer indication the Agency sees a substantial need for biomarker tests whereas in other indications they might be more „informative“.
Confirmation trials should demonstrate that the investigational product provides clinical benefit. From both a clinical and a methodological perspective, the most persuasive outcome of a clinical trial is the demonstration of favourable effects on overall survival. Prolonged progression-free survival and disease-free survival are also considered to be of benefit to the patient. The guideline describes how to select the appropriate endpoints for confirmation studies.
Two appendixes complement the guideline, to address methodological considerations for using progression-free survival in confirmatory trials, and to provide condition specific guidance for non-small cell lung cancer (NSCLC), prostate cancer, chronic myeloid leukaemia (CML), myelodysplastic syndromes, and haematopoietic stem cell transplantation.
25.11.2014 The European biotech IPO slump has finally come to an end. A brand new industry report shows that compared to previous years, the number of biotech IPOs more than doubled in 2014, with London and Paris exchanges leading the pack.
19.11.2014 It’s not every day that a company is pushed into the top ten of its sector, but that day has come for Actavis. Christmas came early for the new pharma giant after completing a US$66bn (€53bn) takeover battle for the Botox manufacturer Allergan.
18.11.2014 Merck KGaA and US rival Pfizer have signed a immuno-oncology alliance worth billions: Merck will share the development and commercialisation of its cancer antibody with its US partner – for €2.3bn.
14.11.2014 Cosily coinciding with World Diabetes Day on 14th November, French biopharma Les Laboratories Servier has struck a US$1bn deal with US pharma Intarcia Therapeutics for the exclusive rights to Intarcia’s unprecedented therapy for type 2 diabetes.
12.11.2014 Glitz and glamour are not words often used to describe science and mathematics. But once a year, celebrities from the science and showbiz world come together at the Breakthough Prizes, a glitzy television bash that honours scientists for their achievements. French life scientist Emmanuelle Charpentier was among this year’s winners.
04.11.2014 Galecto Biotech has entered an agreement with Bristol-Myers Squibb for the acquisition of the company and its lead drug, providing the Swedish company with the potential of reaching over US$400m.