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Attending the patient advocacy session with FDA Oncology & Dr Richard Pazdur made a poignant statement that all advocate communities should hear - we need to redefine the word “tolerable” when discussing side effects. Could not agree more! #ASCO22 #BCSM

Approved today, T-DXd for tx of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemo in the metastatic setting or developed disease recurrence during or within 6 months of adj chemo. Details below #bcsm

Don’t miss the GRASP-SABCS Reception happening in 20 MINUTES from 6-7:30pm in Room 220 (Cantilever Room)! Clinicians, researchers, and advocates are all invited!! #SABCS22

FDA Approval Summary: Fam-Trastuzumab Deruxtecan-nxki for Human Epidermal Growth Factor Receptor 2-Low Unresectable or Metastatic Breast Cancer. First author Dr Preeti Narayan Preeti Narayan, MD, last author Dr Laleh Amiri-Kordestani Laleh Amiri-Kordestani, MD. #OCEPublications pubmed.ncbi.nlm.nih.gov/36780610/

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

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. fda.gov/drugs/drug-app…

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 fda.gov/drugs/resource… Click to #OCENewsBurst ⬆️

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 🔽 aacr.org/professionals/… Preeti Narayan, MD #OCEProjectSocrates

Great start at #SABCS23 with the session on New approval in metastatic #breastcancer 🔸Elacestrant 🔸T-DXd 🔸Capivasertib Happening now at Hemisfair Ballroom 1-2 SABCS OncoAlert

I want to say I appreciate FDA Oncology coming out from behind the curtain and discussing with patients and clinicians their thoughts & rationale around recent approvals. Great session, SABCS 👏🏻

#SABCS23 Day 1 Highlights #CommunityOnc: FDA Oncology Review on recent approvals 1. #CAPItello291 2. #EMERALD 3. #TDxD 4. Tumor Agnostic landscape 5. Post CDK4/6i HR+ SABCS Vivek Subbiah, MD VIRGINIA KAKLAMANI Janice Cowden #bcsm Stephanie Graff, MD, FACP, FASCO Ruth O'Regan 1/6

FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive solid tumors. fda.gov/drugs/resource… #OCENewsBurst

✨Perfect day spending time with colleagues and friends ✨FDA Oncology

🎇 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 ➡️ shareyourvoice.ideascalegov.com/c/ #OCEProject5in5

Today’s #NBCCSummit panel includes National Cancer Institute’s Larissa Korde, Preeti Narayan, MD, NBCC team leader Nicole Seagriff, and Queen’s Global Oncology Program’s Brooke Wilson about why oncology research should be designed to answer questions about outcomes and questions that matter for patients.

“Dose is the foundation of drug development. Having the wrong dose is like building a house on quicksand.” Rick Pazdur, quoted by Preeti Narayan, MD at National Breast Cancer Coalition’s #NBCCSummit.

Mentioned this OCE initiative at National Breast Cancer Coalition Advocate summit today at the outcomes that matter panel discussion, please post any ideas for pragmatic designs! FDA Oncology Jennifer Gao Kelly Norsworthy, MD Steven C. Cunningham Donna Rivera

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

FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer. fda.gov/drugs/resource… #OCENewsBurst

Unfortunately, other obligations kept me and Janice Cowden from attending our favorite Alamo Breast Cancer session with the FDA, but nothing could keep us from at least saying hi to some of our favorite FDA Oncology people! Tatiana Prowell, MD #SABCS24