FDA Accepts Resubmission for RP1 Oncolytic Immunotherapy Plus Nivolumab in PD-1–Refractory Melanoma

FDA Accepts Resubmission for RP1 Oncolytic Immunotherapy Plus Nivolumab in PD-1–Refractory Melanoma

OncoDaily Party Berlin 2025: A Night Where Oncology Met Energy

OncoDaily Party Berlin 2025 ESMO

100 Influential People in Oncology 2025 - Nominations are Open!

100 Influential People in Oncology 2025

Iza-bren (EGFR×HER3 bispecific ADC) 303 Study: Late-breaking ESMO presentation, The Lancet publication, and press-conference Q&A highlights

iza-bren egfrxher3 bispecific press release

Enrique Soto: New ASCO Global Guideline on Geriatric Assessment

Enrique Soto

International Cardio-Oncology Society Introduced the GCOS 2025 Social Media Ambassador Team

International Cardio-Oncology Society Introduced the GCOS 2025 Social Media Ambassador Team

Katy Rezvani: Comprehensive Overview of Engineered Natural Killer Cells for Cancer Therapy

Katy Rezvani

Zihai Li: First-In-Human Anti-GARP CAR-T Trial for Patients With Relapsed GBM

Zihai Li

OncoCalendar

Loading Events

« All Events

  • This event has passed.

2025 FDA-AACR Workshop: Approach to Novel Oncology Endpoint Development

Sep 11 • 8:00 AM - 3:30 PM
2025 FDA-AACR Workshop

U.S. FDA Oncology Center of Excellence and the American Association for Cancer Research (AACR), will host a one-day hybrid workshop on September 11, 2025, at the Hilton Alexandria Old Town. 2025 FDA-AACR Workshop will address the challenges and opportunities in using novel clinical trial endpoints that can inform regulatory decisions, especially in early-stage and rare cancers where overall survival measurement may be impractical.

Key topics include past successes in endpoint development, evidence requirements to validate novel endpoints, balancing risks and benefits, and leveraging these endpoints within accelerated approval pathways. The workshop will feature case studies and discussions led by experts from regulatory agencies, academia, industry, and patient advocacy.

Venue

Hilton Alexandria Old Town
1767 King St VA 22314 + Google Map