Unfortunately, other obligations kept me and @JaniceTNBCmets from attending our favorite @abreastcancer session with the FDA, but nothing could keep us from at least saying hi to some of our favorite @FDAOncology people! @tmprowell#SABCS24
FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer.
https://t.co/ioGzqmxTU3
#OCENewsBurst
What are pragmatic clinical trials? Clinical trials that streamline data collection and design by collecting only necessary information to answer the research question. A thread 🧵 1/5
#ProjectPragmatica#OCEProject5in5#PragmaticTrials
What is FDA Oncology's Project 5 in 5?
⏩ OCE Director Dr. Richard Pazdur explains how 𝘆𝗼𝘂 can take part in crowdsourcing to ultimately select 5 clinically relevant questions to be answered in pragmatic clinical trials.
https://t.co/OIVGCFUGf0
#OCEProject5in5
Today’s #NBCCSummit panel includes @theNCI’s Larissa Korde, @pre_ryan, NBCC team leader Nicole Seagriff, and @QueensGlobalOnc’s Brooke Wilson about why oncology research should be designed to answer questions about outcomes and questions that matter for patients.
🎇 Today, Sunday, May 5 - #CincodeMayo - We officially launch Project 5 in 5: Crowdsourcing 5 clinically relevant questions for 5 pragmatic clinical trials!
💡 What's your clinical trial idea? Sign up and submit ideas here ➡️ https://t.co/OIVGCFUGf0
#OCEProject5in5
FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive solid tumors. https://t.co/PrklmlcNRg
#OCENewsBurst
I want to say I appreciate @FDAOncology coming out from behind the curtain and discussing with patients and clinicians their thoughts & rationale around recent approvals. Great session, @SABCSSanAntonio 👏🏻
The latest episode of #OCEProjectLivinLabel - fam-Trastuzumab Deruxtecan-nxki: The Backstory – is now available!
Watch the episode and read the labeling to receive free CME credit offered by @AACR.
Click here 🔽 https://t.co/Fa7jZkbMfS
@pre_ryan#OCEProjectSocrates
FDA approved capivasertib with fulvestrant for HR+ HER2-neg locally advanced/metastatic breast cancer with PIK3CA/AKT1/PTEN alterations following progression on endocrine-based regimen or recurrence on completing adjuvant therapy
https://t.co/jLqjsSLT7K
Click to #OCENewsBurst ⬆️
Today FDA approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent dMMR or MSI-H endometrial cancer.
https://t.co/7WefziwXrN
Important article for the oncology community on drug shortages and FDA's role, root causes for these shortages, and strategies to address -link is open access @OncoAlert
Read an interview with OCE Director Richard Pazdur about causes of oncology drug shortages and what the FDA can and can't do to fix it, via @TheCancerLetter open access article.