Kirsten B. Goldberg

FDA approves pembrolizumab for adenocarcinoma On March 19, 2025, the FDA granted traditional approval to pembrolizumab (Keytruda, Merck) for HER2 positive gastric or gastroesophageal junction adenocarcinoma

FDA approves a treatment for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 www.fda.gov/drugs/resour...

FY25 FDA Broad Agency Announcement - Q&A Session FY25 FDA Broad Agency Announcement - Question and Answer Session

FY25 FDA Broad Agency Announcement Question and Answer Session - January 16, 2025. Learn about the application process for FDA extramural research funding
www.fda.gov/science-rese...

After 25 years as FDA’s chief cancer strategist, Richard Pazdur reflects on opportunities for change at the agency. #FDA #Oncology
https://cancerletter.com/conversation-with-the-cancer-letter/20250110_1

2025 FDA-AACR Workshop: DPD Deficiency and Weighing Potential Harms AACR is hosting a workshop with the FDA on January 16, 2025, to discuss the considerations for routine testing of DPD deficiency before treatment with fluoropyrimidines.

FDA Oncology and @theaacr.bsky.social are holding a workshop Jan 16 to discuss DPD deficiency testing, the current landscape and future directions.

www.aacr.org/professional...

FDA Oncology Center and EMA will hold a #ConversationsOnCancer on innovation in treatment of #cervical cancer. Jan 14, 10 AM ET/16:00 CET.

📅 Register to receive the YouTube link to watch at that time or later

www.fda.gov/news-events/...

Autopsy of a Drug Withdrawal — The Case of Melphalan Flufenamide | NEJM A December 2022 law introduced a new expedited withdrawal process for accelerated approvals. The first approval withdrawn with this pathway was that of melphalan flufenamide.

Autopsy of a Drug Withdrawal — The Case of Melphalan Flufenamide - via @NEJM. First author, FDA hematologist-oncologist Bindu Kanapuru, last author FDA Oncology Center Director Richard Pazdur. Also check out the accompanying interview with Dr. Kanapuru.

www.nejm.org/doi/full/10....

Pediatric Oncology Drug Approvals Pediatric Oncology Drug Approvals

Since the early 1950s, the FDA has approved more than 60 drugs with over 85 associated indications for the treatment of #pediatric #cancers. View and download the list here, updated through Nov 30, 2024. www.fda.gov/about-fda/on...

Oh, what a great hashtag! Thanks

Another day, another social media platform! They say this is where #MedTwitter has gone. Hope to find you all again, especially #oncology folks.