BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//Catalyst Calendar//CN-US Event Research//ZH
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:Catalyst Calendar
X-WR-CALDESC:Market-moving event research, reminders and post-event review.
BEGIN:VEVENT
UID:evt-fda-astrazeneca-camizestrant-extended-review-2026@catalyst-calendar.local
DTSTAMP:20260720T200628Z
DTSTART:20260816T035900Z
DTEND:20260816T042900Z
SUMMARY:FDA camizestrant乳腺癌NDA延长审评窗口
DESCRIPTION:AstraZeneca宣布FDA延长camizestrant联合CDK4/6抑制剂用于HR+/HER2-晚期乳腺癌ESR1突变患者一线治疗的PDUFA审评，以评估补充数据。该事件无明确新PDUFA日期，作为未来60天内监管watch窗口跟踪。\\nImpact score: 72\\nExpected: 等待FDA给出更新审评结果或新时间表；重点关注ctDNA清除数据、ODAC争议后标签范围及伴随诊断要求。\\nAffected: AZN(subject\, mixed\, score 78)\; PFE(peer\, mixed\, score 45)\; LLY(peer\, mixed\, score 44)\; IBB(etf\, mixed\, score 42)\\nSources: AstraZeneca FDA extension: https://www.astrazeneca.com/media-centre/press-releases/2026/us-fda-decision-date-camizestrant-extended.html\\nFDA ODAC camizestrant meeting: https://www.fda.gov/advisory-committees/advisory-committee-calendar/april-30-2026-meeting-oncologic-drugs-advisory-committee-meeting-announcement-04302026\\nInformation only. Not investment advice.
URL:https://0.0.0.0:3000/?event=evt-fda-astrazeneca-camizestrant-extended-review-2026
CATEGORIES:fda\,US\,FDA\,PDUFA extension\,breast cancer\,SERD\,ESR1
SEQUENCE:0
BEGIN:VALARM
TRIGGER:-P1D
ACTION:DISPLAY
DESCRIPTION:Review catalyst preview: FDA camizestrant乳腺癌NDA延长审评窗口
END:VALARM
BEGIN:VALARM
TRIGGER:PT24H
ACTION:DISPLAY
DESCRIPTION:Complete post-event review: FDA camizestrant乳腺癌NDA延长审评窗口
END:VALARM
END:VEVENT
END:VCALENDAR