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FDA Oncology
May 29, 2025, 18:26 | Blog
Bench To Bedside on Drug Development for Rare and Economically Infeasible Cancers - FDA Oncology
FDA Oncology shared a post on X: "FDA Bench To Bedside video alert! The FDA…
May 28, 2025, 07:50 | Blog
FDA Oncology - Overall Survival and PARP Inhibitors in Advanced Ovarian Cancer
FDA Oncology posted on X: "FDA article outlines the decision-making process and rationale behind removal…
May 19, 2025, 18:28 | Blog
Cancer treatment has evolved dramatically - FDA Oncology
FDA Oncology shared on X: "Cancer treatment has evolved dramatically! Then: Surgery and radiation were…
May 18, 2025, 11:49 | Blog
How Cancer Treatment Has Transformed with Modern Therapies - FDA Oncology
FDA Oncology shared a post on X: "Cancer treatment has evolved dramatically! Then, Surgery and…
May 15, 2025, 14:19 | Blog
FDA Approves the First Oral Treatment for Pheochromocytoma and Paraganglioma - FDA Oncology
FDA Oncology shared a post on X: "FDA approves the first oral treatment for pheochromocytoma and…
Mar 1, 2025, 12:41 | Science
Gilberto Lopes: ctDNA decrease and clearance are associated with PFS and OS in lung cancer
Gilberto Lopes, Chief of the medical oncology division and professor of clinical medicine at the…
Jan 28, 2025, 08:28 | Blog
Cathy Eng: Creating a new standard of care with Checkmate 8HW
Cathy Eng, VICC Associate Director of Strategic Relations and Research Partnerships at Vanderbilt-Ingram Cancer Center, posted…
Jan 19, 2025, 05:34 | Blog
New Bench to Bedside Chats from Project Catalyst’s initiative - FDA Oncology
FDA Oncology shared a post on X: "Check out new Bench to Bedside Chats from…
Jan 18, 2025, 07:20 | Blog
Project Connect - A new global initiative from the FDA Oncology Center
FDA Oncology shared a post on X: "Join Project Connect, a new global initiative from…
Jan 15, 2025, 16:31 | Blog
An excerpt from the just-concluded Conversations on Cancer panel discussion - FDA Oncology
FDA Oncology shared a post on X: "Don’t hesitate to seek support. It makes a…
Jan 14, 2025, 09:30 | Blog
Exploring pharmacogenetic testing for DPD deficiency - FDA Oncology
FDA Oncology posted on X: "FDA Oncology Center's Jennifer Gao and AACR President Patricia M.…
Jan 6, 2025, 19:13 | Insight
Join FDA Oncology‘s Conversations On Cancer event
FDA Oncology shared a post on X: “Join us for a Conversations On Cancer event…
Dec 30, 2024, 13:25 | Blog
Sanjay Popat: Wouldn’t it be great if FDA Oncology approvals were mutually approvable by MHRA?
Sanjay Popat, Thoracic Oncologist at The Royal Marsden NHS Foundation Trust, shared a post on…
Dec 30, 2024, 12:39 | Insight
When Diversity Goals Meet Multiregional Trials by Gautam Mehta et al. - FDA Oncology
FDA Oncology shared a post on X about a recent paper by Gautam Mehta et…
Dec 28, 2024, 18:13 | Drugs
Ever wondered how cancer drugs are approved?
FDA Oncology shared a post on X: “Ever wondered how cancer drugs are approved? Learn…
Dec 27, 2024, 07:00 | Blog
Registration is open for FDA - AACR workshop on DPD deficiency testing, the current landscape and future directions
FDA Oncology shared a post on X: "FDA Oncology and AACR are jointly holding a…
Dec 21, 2024, 07:31 | Insight
Update on U.S. regulatory review of subcutaneous amivantamab for EGFR + lung cancer
Estela Rodriguez shared a post on X: "This is disappointing. I thought we would have…
Dec 11, 2024, 17:38 | Blog
SABCS24 Day 1 Highlights by Oncology Brothers
Oncology Brothers shared a post on X: "SABCS24 Day 1 Highlights CommunityOnc: FDA Oncology Reviews recent…
Dec 11, 2024, 16:18 | Opinion
Paolo Tarantino: SABCS 2024 day 1 kicked off with FDA Oncology special session on drug approval
Paolo Tarantino, Research fellow at Dana-Farber Cancer Institute, posted on X: "SABCS24 day 1 kicks…
Dec 6, 2024, 05:13 | Blog
Aparna Raj Parikh: 1st Steering Committee Meeting of Our “RER” Team
Aparna Raj Parikh, Associate Professor of Medicine at Harvard Medical School and a Gastrointestinal Oncologist…
Nov 25, 2024, 12:34 | Drugs
Aakash Desai: FDA approves a biparatopic, Zanidatamab - targeting HER2 for BTCs
Aakash Desai, Associate Director and Assistant Professor at UAB O’Neal Comprehensive Cancer Center, shared a post…
Nov 18, 2024, 13:13 | Blog
Pediatric Cancers: Navigating the Challenges Together - panel discussion hosted by FDA Oncology Center and EMA
FDA Oncology shared a post on X: "Pediatric Cancers: Navigating the Challenges Together - upcoming…
Nov 4, 2024, 09:03 | Insight
Dr. Richard Pazdur: 25 Years of Transforming Oncology Drug Development at the FDA
In a career that spans nearly half a century in oncology, including 25 years at…
Oct 17, 2024, 16:04 | Insight
Estela Rodriguez: Novocure’s Optune Lua TTF (device) plus docetaxel or Immunotherapy for 2L NSCLC
Estela Rodriguez shared a post on X: "Its only Tuesday and we have another ⁦FDA…
Oct 12, 2024, 10:28 | Blog
FDA Oncology seeks consumer reps for the Oncologic Drugs Advisory Committee
FDA Oncology posted on X: "FDA seeks consumer reps for the Oncologic Drugs Advisory Committee…
Oct 5, 2024, 02:12 | Insight
Eric K. Singhi: FDA Oncology approves amivantamab and chemo for EGFR and NSCLC
Eric K. Singhi shared a post on X: “FDA Oncology approves amivantamab and chemo for…
Oct 4, 2024, 06:03 | Drugs
FDA approved Neoadjuvant/Adjuvant Nivolumab for resectable NSCLC
FDA Approval Introduces New Treatment Options for Adults with Resectable Lung Cancer Lacking Key Genetic…
Sep 4, 2024, 07:45 | Drugs
Measuring Toxicity in Reproductive Organs during Oncology Drug Development – a FDA-ASCO Workshop
FDA Oncology shared on X: "Register now for Measuring Toxicity in Reproductive Organs during Oncology…
Aug 29, 2024, 16:53 | Insight
Dario Trapani: Very informative story on how clinical trials have been so far "tolerated" in their design
Dario Trapani shared a post on X about a paper by Vinay Prasad et al.…
Aug 27, 2024, 11:31 | Blog
FDA seeks Consumer Representatives for the Oncologic Drugs Advisory Committee - FDA Oncology
FDA Oncology shared on X: "FDA seeks Consumer Representatives for the Oncologic Drugs Advisory Committee…
Aug 24, 2024, 13:58 | Insight
Jennifer Marks: The new NSCLC FDA Oncology approvals
Jennifer Marks, Thoracic Oncologist at Georgetown Lombardi, shared a post on X, referencing an earlier…
Aug 23, 2024, 06:30 | Drugs
Taha Al-Juhaishi: Treatment of AML in the community setting
Taha Al-Juhaishi, Associate Director of Hematopoietic Stem Cell Transplantation and Cell Therapy at OU Health…
Aug 21, 2024, 17:08 | Insight
What oncologists say about the new approval of Lazertinib and amivantamab for advanced NSCLC
On August 19, 2024, the FDA approved a new combination therapy for advanced non-small cell…
Aug 6, 2024, 10:58 | Blog
The OCE Summer Scholars Program wrapped up its 8th summer - FDA Oncology
FDA Oncology posted on X: “The OCE Summer Scholars Program wrapped up its 8th summer…
Aug 4, 2024, 09:29 | Drugs
The FDA Oncology has approved the first T cell receptor gene therapy for adults with metastatic synovial sarcoma - SITC
Society for Immunotherapy of Cancer (SITC) shared on X: "The FDA Oncology has approved the…
Aug 2, 2024, 12:25 | Blog
Applications for the 2024-25 FDA-AACR Oncology Educational Fellowship are due Aug 14
FDA Oncology shared on X: "Applications for the 2024-25 FDA-AACR Oncology Educational Fellowship are due Aug…
Aug 2, 2024, 01:49 | Blog
FDA Oncology - ASCO is accepting applications for the October 2024 Hybrid FDA- ASCO Fellows’ Day
FDA Oncology shared on X: "ASCO is now accepting applications for the October 2024 Hybrid FDA-…
Aug 1, 2024, 09:29 | Blog
The August issue of the OCE PULSE for updates on FDA Oncology educational opportunities
FDA Oncology shared on X: ”Just posted! Check out the August issue of the OCE…
Aug 1, 2024, 07:29 | Blog
Udhayvir Grewal: Strongly recommend applying for FDA-ASCO workshop
Udhayvir Grewal shared a post by FDA Oncology, on X: "It was an amazing experience…
Jul 30, 2024, 13:31 | Blog
401 phone calls and 889 Expanded Access applications in 2023 by OCE's Project Facilitate
FDA Oncology shared on X: "In 2023, OCE's Project Facilitate handled 401 phone calls and…
Jul 30, 2024, 13:23 | Insight
Treatment of CML in pregnant patients and patients who are breastfeeding
FDA Oncology shared on X: An expert panel convened by FDA provides perspectives on drug…
Jul 29, 2024, 13:54 | Blog
OCE's first National Hispanic Family Cancer Awareness Week - FDA Oncology
FDA Oncology posted on X: "Announcing OCE's first National Hispanic Family Cancer Awareness Week! September…
Jul 29, 2024, 13:24 | Insight
Gautam Mehta et al. summarize the FDA accelerated approval of fam-trastuzumab deruxtecan-nxki - FDA Oncology
FDA Oncology shared a post on X about a paper titled "FDA approval summary: fam-trastuzumab…
Jul 28, 2024, 14:38 | Drugs
Elad Sharon: Contribution of effect is an under appreciated and essential part of drug development
Elad Sharon, Clinical and Translational Director of Dana-Farber Cancer Institute, shared a post by FDA Oncology…
Jul 27, 2024, 14:57 | Insight
Edward Cliff: The development and clinical trial design of T-cell lymphoma drugs pralatrexate and belinostat
Edward Cliff, Haematology Registrar at Peter MacCallum Cancer Centre and The Royal Melbourne Hospital, shared a…
Jul 27, 2024, 02:50 | Blog
Patrick Forde: Interesting ODAC for future perioperative trial designs
Patrick Forde, Professor at the Johns Hopkins University, shared a post on X by FDA…
Jul 26, 2024, 06:54 | Insight
Discussions around updated OS data from Aegean Trial
AEGEAN trial is a phase 3 trial that tested the combination of perioperative durvalumab, a…
Jul 25, 2024, 21:25 | Blog
Elad Sharon: Another win for patients with ALL
Elad Sharon, Clinical and Translational Director of Dana-Farber Cancer Institute, shared on X: "Another win for…
Jul 25, 2024, 08:28 | Blog
Recommendations to improve using Overall Survival data to inform benefit-risk assessments - FDA Oncology
FDA Oncology posted on X about recent paper by Lisa Rodriguez et al., commenting:  "In…
Jul 21, 2024, 13:57 | Blog
Herbert Loong: Regulatory processes for novel oncology therapeutics and cellular therapies at APODDC forum
Herbert Loong shared a post on X: ''We welcomed Ke Liu, former Chief of Oncology…
Jul 20, 2024, 01:30 | Blog
Applications for the 2024-25 FDA-AACR Oncology Educational Fellowship are due August 14
FDA Oncology shared a post on X: ''Applications for the 2024-25 FDA-AACR Oncology Educational Fellowship…
Jul 19, 2024, 22:19 | Insight
Gautam Mehta summarizes the FDA accelerated approval of fam-trastuzumab deruxtecan-nxki for HER2-mutated NSCLC
FDA oncology shared on X: "OCE's Gautam Mehta and colleagues summarize the FDA accelerated approval…
Jul 19, 2024, 16:04 | Blog
Attend the 2024 FDA Oncology Center of Excellence Pediatric Advocacy Forum
FDA Oncology shared on X: "Save the date and register to attend the 2024 FDA…
Jul 14, 2024, 22:09 | Blog
OCE's role in cancer drug development, regulation, and patient advocacy since 2017 - FDA Oncology
FDA Oncology shared a post on X: ''Thank you to FDA Oncology Center of Excellence…
Jul 13, 2024, 19:38 | Blog
Apply for the 2024-25 FDA-AACR Oncology Educational Fellowship
FDA Oncology shared on X/Twitter:                       …
Jul 10, 2024, 17:55 | Drugs
A Cancer Cabinet Community Conversation - FDA Oncology
FDA Oncology shared on X: "Join us on July 11 for a Cancer Cabinet Community…
Jul 9, 2024, 14:37 | Blog
Let's commit to healthy skin habits for a safer future - FDA Oncology
FDA Oncology shared a post on X: ''Take steps to protect your skin from the…
Jul 7, 2024, 15:49 | Blog
Kelly Norsworthy: Submit your Pragmatic Trials ideas to FDA Oncology
Kelly Norsworthy, Deputy Division Director, Division of Hematologic Malignancies 1 at Johns Hopkins University, shared…
Jul 7, 2024, 12:04 | Insight
Exploring religious literacy and spirituality in cancer care - FDA Oncology
FDA Oncology shared on X: "July 10 panelist, Paul Galchutt, serves as assistant director of…
Jul 7, 2024, 04:58 | Insight
Cancer cabinet community conversation on July 11 - FDA Oncology
FDA Oncology shared on X: “Join us for a special Cancer Cabinet Community Conversation on…
Jul 5, 2024, 05:29 | Blog
FDA Oncology - Conversations On Cancer with Gwynn Ison
FDA Oncology shared on X: "Gwynn Ison MD is a medical oncologist and clinical reviewer in…
Jul 3, 2024, 04:18 | Blog
FDA and WHOSTP discuss increasing clinical trials access and lowering barriers to participation
FDA Oncology shared on X: “FDA Oncology Center's Paul Kluetz, Rick Pazdur, Donna Rivera attended…
Jul 1, 2024, 12:51 | Blog
Career Development Beyond the FDA-AACR Oncology Educational Fellowship
FDA Oncology posted on X: "Reflections and Roadmaps: Career Development Beyond the FDA-AACR Oncology Educational Fellowship…
Jul 1, 2024, 02:27 | Blog
Krishna Komanduri: Big deal and a win for immunotherapy patients
Krishna Komanduri, Physician in Chief at UCSF Helen Diller Family Comprehensive Cancer Center, made the following post…
Jun 25, 2024, 07:47 | Blog
Mark Lewis: It is UNACCEPTABLE to treat mCRC without knowing these biomarker
Mark Lewis shared a post by FDA Oncology on X, adding the following:   . “We…
Jun 22, 2024, 14:35 | Drugs
FDA grants accelerated approval to adagrasib with cetuximab for KRAS G12C-mutated colorectal cancer
FDA Oncology shared on X: "FDA grants accelerated approval to adagrasib with cetuximab for KRAS…
Jun 22, 2024, 10:04 | Blog
Submit pragmatic trial ideas for Project 5 in 5 - FDA Oncology
FDA Oncology shared on X: "Project 5 in 5 crowdsourcing results will be shared with…
Jun 21, 2024, 11:57 | Blog
Elad Sharon: Two of my major trials led to FDA Oncology approvals
Elad Sharon, Clinical and Translational Director of Dana-Farber Cancer Institute, shared on X/Twitter: "Past week,…
Jun 18, 2024, 09:57 | Insight
Top 5 articles of the week - Cancer Network
Cancer Network shared on X/Twitter: "View our top 5 articles of the week: T-DXd Boosts…
Jun 18, 2024, 02:59 | Blog
Estela Rodriguez: Another tumor - agnostic approval
Estela Rodriguez shared a post on X: "Another tumor-agnostic approval. FDA Oncology grants accelerated approval…
Jun 15, 2024, 02:59 | Blog
FDA Oncology - Luckson Mathieu will be speaking at Mass General Cancer Center 2024
FDA Oncology shared a post on X: "FDA Oncology Center's Dr. Luckson Mathieu will be speaking…
Jun 14, 2024, 14:35 | Blog
FDA Oncology - FDA’s Oncology Center of Excellence Launches Project 5 in 5
FDA Oncology shared a post on X: "FDA’s Oncology Center of Excellence Launches Project 5 in…
Jun 13, 2024, 07:14 | Insight
What happened when Swissmedic joined FDA Oncology Center's Project Orbis
FDA Oncology shared a post by The Lancet Oncology on X/Twitter: "What happened when Swissmedic joined…
Jun 12, 2024, 12:18 | Blog
Participate in our next conversations on cancer - FDA Oncology
FDA Oncology shared a post on X/Twitter: ''Participate in our next conversations on cancer on…
Jun 11, 2024, 10:43 | Blog
Laura Crandon will serve as a panelist at the June Conversations on Cancer - FDA Oncology
FDA Oncology shared a post on X/Twitter: ''Laura Crandon will also serve as a panelist…
Jun 3, 2024, 23:40 | Blog
Christine Hodgdon: Project 5 in 5 is a crowdsourcing initiative from FDA’s Oncology Center of Excellence
Christine Hodgdon, Stage IV Breast Cancer Survivor and Advocate treated at Johns Hopkins, shared a…
Jun 1, 2024, 10:06 | Blog
Richard Pazdur took part in a Cancer Drug Development Forum Multi-Stakeholder Workshop on Clinical Research in Central and Eastern Europe - FDA Oncology
FDA Oncology shared on X/Twitter: "FDA Oncology Center Director Richard Pazdur took part in a…
May 29, 2024, 12:55 | Societies
FDA Oncology experts will be speaking at the ASCO Annual Meeting
FDA Oncology recently shared a post on X: "Attending ASCO24? FDA Oncology experts will be…
May 27, 2024, 07:35 | Blog
Check out the state of immunotherapy in resectable NSCLC - FDA Oncology
FDA Oncology shared a post on X: “Check out the state of immunotherapy in resectable NSCLC:…
May 26, 2024, 10:24 | Blog
Fellows of the FDA-AACR 2023-2024 Oncology Educational Fellowship - FDA Oncology
FDA Oncology shared a post on X: “FDA Oncology Center of Excellence welcomed fellows of the…
May 22, 2024, 04:26 | Blog
Warren Fingrut: 2nd-ever Health Disparities in Hematologic Malignancies Conference
Warren Fingrut, Hematologist and Stem Cell Transplant physician at MD Anderson Cancer Center, posted on…
May 21, 2024, 12:50 | Blog
Brenda Adjei will serve as a panelist for the June 13 Conversations On Cancer - FDA Oncology
FDA Oncology shared a post on X: “Brenda Adjei, Ed.D., will serve as a panelist for…
May 13, 2024, 10:23 | Blog
An FDA Oncology Center of Excellence Project Community quarterly newsletter
FDA Oncology shared on X: "OCE ENGAGE: An FDA Oncology Center of Excellence Project Community…
May 13, 2024, 05:26 | Blog
AACR - Joint workshop on Trial Designs for Treatment Regimens with Multiple Phases
AACR shared a post on X: "AACR Past President Elizabeth M. Jaffee and FDA oncology's Harpreet…
May 8, 2024, 12:42 | Blog
Julie Gralow: Share your voice to FDA Oncology's Project 5 in 5 crowdsourcing initiative
Julie Gralow shared a post on X: "Share your voice to FDA Oncology's Project 5 in…
May 7, 2024, 15:45 | Blog
FDA Oncology's Project 5 in 5
Kelly Norsworthy, Deputy Division Director, Division of Hematologic Malignancies 1 at Johns Hopkins University, shared a…
Apr 28, 2024, 16:36 | Blog
FDA Oncology: OCE's Project Facilitate processed 401 calls and 889 applications for oncology investigational drugs
FDA Oncology shared a post on X: "In 2023, OCE's Project Facilitate handled 401 phone…
Apr 21, 2024, 21:08 | Insight
Alison Silberman is one of the FDA Oncology panelists for the upcoming Conversations on Cancer
 FDA Oncology shared on X: “Alison Silberman is one of our panelists for the upcoming conversations…
Apr 20, 2024, 19:03 | Blog
How Much is Enough? Trial Designs for Treatment Regimens with Multiple Phases - FDA Oncology
FDA Oncology shared on X/Twitter: "How Much is Enough? Trial Designs for Treatment Regimens with…
Apr 19, 2024, 15:52 | Drugs
FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer based on ALINA trial
FDA, the Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.) for adjuvant treatment following…
Apr 13, 2024, 13:13 | Positive
Vivek Subbiah: An absolute honor to meet the legendary Rick Pazdur at the FDA Oncology!
Vivek Subbiah posted on X/Twitter: "An absolute honor to meet the legendary Rick Pazdur at…
Apr 7, 2024, 23:49 | Blog
Dr. Nicole Drezner from FDA will be speaking at the upcoming ALADDIN Webinar - FDA Oncology
FDA Oncology posted on X: “Dr. Nicole Drezner from FDA will be speaking at the upcoming…
Apr 7, 2024, 07:37 | Blog
Fumiko Ladd Chino: A program for 11/12th graders in the Washington DC Metro Area
Fumiko Ladd Chino shared a post by Tatiana Prowell, on X: "This program for 11/12th…
Apr 6, 2024, 07:14 | Drugs
Antonio Passaro: Why is this press release of Bristol Myers Squibb so crucial for our community?
Antonio Passaro, Medical Director at the Institute of European Oncology (IEO), shared a post on…
Apr 3, 2024, 14:15 | Insight
FDA Oncology medical reviewers wrote more than 500 articles for peer-reviewed journals from 2018-2023
FDA Oncology posted on X: "DYK? FDA Oncology medical reviewers wrote more than 500 articles for…
Apr 1, 2024, 09:45 | Blog
An oncologist doesn't have to be a researcher to use Expanded access for their patients with cancer - FDA Oncology
FDA Oncology shared on X/Twitter: "An oncologist doesn't have to be a researcher or belong to…
Mar 26, 2024, 19:09 | Drugs
FDA approves safety labeling changes regarding DPD deficiency for fluorouracil injection products - FDA Oncology
FDA Oncology shared on X/Twitter: "FDA approves safety labeling changes regarding DPD deficiency for fluorouracil injection…
Mar 24, 2024, 23:14 | Blog
FDA Oncology: FDA Oncology's Dan Suzman discusses approaches to oncology trials and regulatory issues
FDA Oncology recently shared a post on X: “FDA Oncology's Dan Suzman discusses approaches to…
Mar 21, 2024, 12:22 | Blog
OCE Project Community provides information for patients, consumers and caregivers - FDA Oncology
FDA Oncology recently shared a post on X/Twitter: "OCE Project Community provides information for patients,…
Mar 20, 2024, 14:34 | Blog
Dive into the world of Precision Medicine this Myeloma and Colorectal Cancer Awareness Month - FDA Oncology
Quoting FDA Oncology on X: "Dive into the world of Precision Medicine this Myeloma and…
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