Oncology office director Pazdur says whole data package supporting accelerated approval in neoadjuvant breast cancer of Roche’s Perjeta was far stronger than the data for GSK’s Tykerb, which just failed in ALTTO. FDA is standing by use of pCR as a surrogate endpoint but says only a select group of drugs will qualify.
Revised guidance on the accelerated approval pathway for neoadjuvant breast cancer likely will include an assessment of the failed ALTTO study of GlaxoSmithKline PLC’s Tykerb, but FDA does not plan to alter its course on speeding clearance of new drugs that show a robust effect early in high-risk women.
Described as the “largest-ever” trial in HER2+ breast cancer in the adjuvant (post-operative) setting, the study of more than 8,000...
IQWiG, Germany’s health technology assessment body, is making contingency plans in case key US resources it relies on for information retrieval, when conducting benefit assessments of new medicines, become unavailable.
ISRCTN says its new system for reporting clinical trial results summaries will simplify compliance, and includes features to reduce data entry errors, improve accuracy, enhance accessibility and the reuse of trial results.
Sponsors running clinical trials in the UK can get a decision on their applications to make substantial but low-risk amendments to their studies within 14 days under a pilot that is testing a streamlined pathway ahead of new clinical trial regulations coming into force in April 2026.
The European Medicines Agency’s inaugural bilateral meeting with the Association of Clinical Research Organizations underscores ACRO’s commitment to advancing innovation and its presence in the EU clinical trials ecosystem.
Acknowledging the risks and limitations of factorial designs, draft guidance outlines how sponsors might employ external data, such as registries or patient-level real-world data, for combination cancer therapies.
The first “Rare disease Innovation, Science and Exploration (RISE) meeting to discuss the choice of control arms for studies in small populations will be Sept. 3 after plans were delayed by ongoing changes at the FDA.
The pharmaceutical industry is edging closer to EU-wide clarity on how the bloc’s data privacy rules can be applied consistently to clinical trials and pharmacovigilance activities.
