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EMA rules for cancer drugs

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.

© eurobiotechnews.eu/tg

http://www.european-biotechnology-news.com/news/news/2013-01/ema-rules-for-cancer-drugs.html

Industry reportGermany

27.04.2016 More revenue, more jobs, more financing, more R&D expenditure – all signs point towards sustainable growth in the German biotech sector. These are the results of the most recent company survey 2016, published by biotechnologie.de. The report was once again conducted alongside the biotech standards defined by the organisation for economic cooperation and development (OECD).

Clinical ResearchFrancePortugal

21.04.2016 An expert panel’s final report on the fatal drug trial earlier this year in France states that the death of one of the participants was most likely caused by the drug’s toxicity and not by any violation of the rules.

Immuno-oncologyNetherlandsBelgium

21.04.2016 For up to US$685m (€606m), Dutch ArgenX has outlicensed its human antibody programme ARGX-115 to AbbVie. The pre-clinical immuno-oncology candidate targets a protein believed to contribute to immunosuppressive effects of T-cells.

RegulatorySwitzerlandEU

20.04.2016 The US government is forking out up to US$100m to get Basilea Pharmaceutica’s broad-spectrum antibiotic ceftobiprole on the US market. In the EU, ceftobiprole is already available.

Immuno-oncologyUK

19.04.2016 British drug developer Heptares Therapeutics and mAb maker Kymab Ltd have partnered up in yet another immuno-oncology collaboration. The companies plan to discover antibody meds targeting a superfamily of receptors.

FinancingSwitzerlandFranceEUGermanyDenmark

15.04.2016 Not every company is put off by the current stock market climate. Swiss biopharma company GeNeuro has gone public at Euronext Paris, raising €33m in the process. Others, meanwhile, have to find different ways to raise money.

Event ReviewSwitzerlandBelgiumEU

13.04.2016 Despite political disturbances, 2015 was a good year for the biotech scene in Switzerland. Net sales increased by 5.1% to CHF5,133m and 400 additional people found jobs in the sector. As usual, the new numbers were presented at the annual Swiss Biotech Day – which set new records as well.

FinancingGermanyNetherlandsEU

12.04.2016 German-Dutch life science investment specialist Forbion Capital Partners has raised more than €180m for its venture capital fund Forbion Capital Fund III. Once more the money will primarily go to European start-ups.

Event ReviewGermanyEU

08.04.2016 Do you win by being innovative?, was the question asked at this year’s DIA Euromeeting in Hamburg. In a relaxed and cooperative atmosphere, regulators, physicians and patients had ample opportunity to interact with the healthcare industry.

M&AIrelandEU

07.04.2016 Pfizer and Allergan have called off their merger, cancelling plans to relocate the US pharma giant to Ireland to avoid US taxation. The US government has put a spoke in Pfizer’s wheels - an unfair move, Allergan says.

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