camizestrant

Celcuity's Gedatolisib Trial Misses Expectations, Highlighting PIK3CA Inhibitor Challenges

breast cancer · 6 min

Celcuity's Phase 3 VIKTORIA-1 trial for gedatolisib in PIK3CA-mutated breast cancer did not meet 'lofty' expectations, prompting a re-evaluation of PIK3CA inhibitor development. This analysis examines the trial outcomes, competitive landscape, and strategic implications for pharmaceutical teams.

ASCO26: AstraZeneca's Camizestrant Data Aims to Sway FDA Approval

FDA · 8 min

AstraZeneca is presenting new data for its oral selective oestrogen receptor degrader (SERD), camizestrant, at ASCO26, hoping to bolster its case for FDA approval. The drug demonstrated a 56% reduction in the risk of disease progression or death in recent trials.

FDA Delays Decision on AstraZeneca's Camizestrant Following Negative Adcomm Vote

FDA · breast cancer · 9 min

The FDA has extended its review period for AstraZeneca's oral SERD drug, camizestrant, following a negative recommendation from an advisory committee. The delay stems from the regulator's need to review additional data requested after the panel raised concerns about the Phase 3 SERENA-6 trial's design and the lack of survival data.

This Week in Breast Cancer: Camizestrant Delay, Bria-IMT Data, Recurrence Test

FDA · breast cancer · 9 min

Structured plan for This Week in Breast Cancer: Camizestrant Delay, Bria-IMT Data, Recurrence Test