#SABCS24 Day 1 Highlights #CommunityOnc:
1. @FDAOncology Reviews recent approvals: #Ribociclib & #Inavolisib
2. #PADMA: HR+ ET + CDK4/6i vs Chemo 1L
3. #DB06: HR+ TDXd
4. #KN522: biomarker analysis
#OncSky #CanSky @sabcs.bsky.social @drsarahsammons.bsky.social @dr-rshatsky.bsky.social
1/5
1. @FDAOncology Reviews recent approvals: #Ribociclib & #Inavolisib
2. #PADMA: HR+ ET + CDK4/6i vs Chemo 1L
3. #DB06: HR+ TDXd
4. #KN522: biomarker analysis
#OncSky #CanSky @sabcs.bsky.social @drsarahsammons.bsky.social @dr-rshatsky.bsky.social
1/5
December 11, 2024 at 2:26 AM
#SABCS24 Day 1 Highlights #CommunityOnc:
1. @FDAOncology Reviews recent approvals: #Ribociclib & #Inavolisib
2. #PADMA: HR+ ET + CDK4/6i vs Chemo 1L
3. #DB06: HR+ TDXd
4. #KN522: biomarker analysis
#OncSky #CanSky @sabcs.bsky.social @drsarahsammons.bsky.social @dr-rshatsky.bsky.social
1/5
1. @FDAOncology Reviews recent approvals: #Ribociclib & #Inavolisib
2. #PADMA: HR+ ET + CDK4/6i vs Chemo 1L
3. #DB06: HR+ TDXd
4. #KN522: biomarker analysis
#OncSky #CanSky @sabcs.bsky.social @drsarahsammons.bsky.social @dr-rshatsky.bsky.social
1/5
AACR President Patricia M. LoRusso, DO, PhD (hc), FAACR, presents the AACR Enduring Impact Award for Transformative Service to Cancer Science and Medicine to @FDAOncology director Richard Pazdur, MD, during the #AACR25 Opening Ceremony.
April 27, 2025 at 2:18 PM
AACR President Patricia M. LoRusso, DO, PhD (hc), FAACR, presents the AACR Enduring Impact Award for Transformative Service to Cancer Science and Medicine to @FDAOncology director Richard Pazdur, MD, during the #AACR25 Opening Ceremony.
The future!! Still early days, but coming very fast! Prof @carlobifulco explains why #AI wins out over humans in evaluating #cancer #pathology / #cancer #immunotherapy #SITC2024 #CHATGPT #Microsoft #FDAOncology
November 23, 2024 at 6:39 AM
The future!! Still early days, but coming very fast! Prof @carlobifulco explains why #AI wins out over humans in evaluating #cancer #pathology / #cancer #immunotherapy #SITC2024 #CHATGPT #Microsoft #FDAOncology
#FDAOncology approves a biparatopic, Zanidatamab- targeting HER2 for #BTCs
Based on HERIZON-BTC-01!
➡️ORR: 41.3%, mDOR=14.9 mths
➡️ Approval for IHC 3+, where TDX-d also has agnostic approval
➡️18% Gr3 TRAEs, diarrhea
#Oncosky @oncoalert.bsky.social @viveksubbiah.bsky.social
Based on HERIZON-BTC-01!
➡️ORR: 41.3%, mDOR=14.9 mths
➡️ Approval for IHC 3+, where TDX-d also has agnostic approval
➡️18% Gr3 TRAEs, diarrhea
#Oncosky @oncoalert.bsky.social @viveksubbiah.bsky.social
November 21, 2024 at 6:10 PM
#FDAOncology approves a biparatopic, Zanidatamab- targeting HER2 for #BTCs
Based on HERIZON-BTC-01!
➡️ORR: 41.3%, mDOR=14.9 mths
➡️ Approval for IHC 3+, where TDX-d also has agnostic approval
➡️18% Gr3 TRAEs, diarrhea
#Oncosky @oncoalert.bsky.social @viveksubbiah.bsky.social
Based on HERIZON-BTC-01!
➡️ORR: 41.3%, mDOR=14.9 mths
➡️ Approval for IHC 3+, where TDX-d also has agnostic approval
➡️18% Gr3 TRAEs, diarrhea
#Oncosky @oncoalert.bsky.social @viveksubbiah.bsky.social
Pleased to share this Editorial in @Oncotarget about
Pitfalls and perils from FDA-approved germ-line cancer predisposition tests
www.oncotarget.com/article/2867...
@oncodaily @OncoAlert @NCCN @FDAOncology
Pitfalls and perils from FDA-approved germ-line cancer predisposition tests
www.oncotarget.com/article/2867...
@oncodaily @OncoAlert @NCCN @FDAOncology
www.oncotarget.com
December 27, 2024 at 11:09 AM
Pleased to share this Editorial in @Oncotarget about
Pitfalls and perils from FDA-approved germ-line cancer predisposition tests
www.oncotarget.com/article/2867...
@oncodaily @OncoAlert @NCCN @FDAOncology
Pitfalls and perils from FDA-approved germ-line cancer predisposition tests
www.oncotarget.com/article/2867...
@oncodaily @OncoAlert @NCCN @FDAOncology
#SABCS24 day 1 kicks off with an interesting @FDAOncology special session on drug approval. First talk tackles the approval of adjuvant ribociclib per NATALEE. Two post-marketing commitments: to provide efficacy in a broader diverse population, and to provide updates on OS. #bcsm
December 10, 2024 at 6:20 PM
FDA Oncology News: June 2025 Updates
@fda.gov
oncodaily.com/science/fda-...
#OncoDaily #Oncology #Cancer #Health #Medicine #MedEd #MedOnc #MedNews #FDA #FDAOncology
@fda.gov
oncodaily.com/science/fda-...
#OncoDaily #Oncology #Cancer #Health #Medicine #MedEd #MedOnc #MedNews #FDA #FDAOncology
FDA Oncology News: June 2025 Updates - OncoDaily
The U.S. Food and Drug Administration (FDA) is a federal agency within the Department of Health and Human Services responsible for protecting
oncodaily.com
July 2, 2025 at 2:06 PM
FDA Oncology News: June 2025 Updates
@fda.gov
oncodaily.com/science/fda-...
#OncoDaily #Oncology #Cancer #Health #Medicine #MedEd #MedOnc #MedNews #FDA #FDAOncology
@fda.gov
oncodaily.com/science/fda-...
#OncoDaily #Oncology #Cancer #Health #Medicine #MedEd #MedOnc #MedNews #FDA #FDAOncology
This is disappointing. I thought we would have #amivantamab subq formulation for EGFR+ #lungcancer for Xmas, which could make drug delivery easier, but @FDAOncology says not yet.
Update on U.S. regulatory review of subcutaneous amivantamab #lcsm www.jnj.com/media-center...
Update on U.S. regulatory review of subcutaneous amivantamab #lcsm www.jnj.com/media-center...
Update on U.S. regulatory review of subcutaneous amivantamab
www.jnj.com
December 18, 2024 at 1:38 PM
This is disappointing. I thought we would have #amivantamab subq formulation for EGFR+ #lungcancer for Xmas, which could make drug delivery easier, but @FDAOncology says not yet.
Update on U.S. regulatory review of subcutaneous amivantamab #lcsm www.jnj.com/media-center...
Update on U.S. regulatory review of subcutaneous amivantamab #lcsm www.jnj.com/media-center...
Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Performance Status Work Group [Feb 9, 2021] @DrAllisonMags et al. @ASCO @CancerResrch @CCR_AACR ow.ly/H6qM50Dw8uD #ClinicalTrials #ctsm @FDAOncology
April 9, 2025 at 2:55 PM
Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Performance Status Work Group [Feb 9, 2021] @DrAllisonMags et al. @ASCO @CancerResrch @CCR_AACR ow.ly/H6qM50Dw8uD #ClinicalTrials #ctsm @FDAOncology
Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO–Friends of Cancer Research Prior Therapies Work Group [Feb 9, 2021] Osarogiagbon et al. @ASCO @CancerResrch @CCR_AACR ow.ly/8P0r50Dw8Ec #ClinicalTrials #ctsm @FDAOncology
April 9, 2025 at 2:56 PM
Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO–Friends of Cancer Research Prior Therapies Work Group [Feb 9, 2021] Osarogiagbon et al. @ASCO @CancerResrch @CCR_AACR ow.ly/8P0r50Dw8Ec #ClinicalTrials #ctsm @FDAOncology
Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Washout Period & Concomitant Medication Work Group [Feb 9, 2021] @DrDonaldHarvey et al. @ASCO @CancerResrch @CCR_AACR ow.ly/XnUG50Dw7UL #ClinicalTrials #ctsm @FDAOncology
April 9, 2025 at 2:54 PM
Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Washout Period & Concomitant Medication Work Group [Feb 9, 2021] @DrDonaldHarvey et al. @ASCO @CancerResrch @CCR_AACR ow.ly/XnUG50Dw7UL #ClinicalTrials #ctsm @FDAOncology
Continuing to Broaden Eligibility Criteria to Make #ClinicalTrials More Representative and Inclusive: ASCO–Friends of Cancer Research Joint Research Statement [Feb 9, 2021] @DrEdKim et al. @rschilsky @ASCO @CancerResrch @CCR_AACR ow.ly/jmPM50DvH0M #ctsm @FDAOncology
April 9, 2025 at 2:54 PM
Continuing to Broaden Eligibility Criteria to Make #ClinicalTrials More Representative and Inclusive: ASCO–Friends of Cancer Research Joint Research Statement [Feb 9, 2021] @DrEdKim et al. @rschilsky @ASCO @CancerResrch @CCR_AACR ow.ly/jmPM50DvH0M #ctsm @FDAOncology
Dr Maura Dickler giving kudos to FDA's Dr Richard Pazdur. As a patient, I'm grateful to the @FDAOncology 's recent stance that trials need to reflect the patient population that will use the drug @METUPorg #SABCS17
November 19, 2024 at 5:45 AM
Dr Maura Dickler giving kudos to FDA's Dr Richard Pazdur. As a patient, I'm grateful to the @FDAOncology 's recent stance that trials need to reflect the patient population that will use the drug @METUPorg #SABCS17
One way I hope to do this is if I am chosen for @AACR survivor-scientist program (can you put in a good word @amos18??) and the @FDAOncology PEC (hi @tmprowell !!) #escape2018 #AdvocacyGoals #bcsm
November 19, 2024 at 5:24 AM
One way I hope to do this is if I am chosen for @AACR survivor-scientist program (can you put in a good word @amos18??) and the @FDAOncology PEC (hi @tmprowell !!) #escape2018 #AdvocacyGoals #bcsm
.love that we advocates are able to have a dialogue with @FDAOncology deputy commissioner Anna Abrahms, who agrees that stage appropriate advocates should be more involved. #AACRSSP18 #AACR18
November 19, 2024 at 2:16 AM
.love that we advocates are able to have a dialogue with @FDAOncology deputy commissioner Anna Abrahms, who agrees that stage appropriate advocates should be more involved. #AACRSSP18 #AACR18
And @METUPorg a d @metavivor get a shout out from @FDAOncology @tmprowell, a great friend of advocates #AACRSSP18 #AACR18
November 19, 2024 at 2:16 AM
And @METUPorg a d @metavivor get a shout out from @FDAOncology @tmprowell, a great friend of advocates #AACRSSP18 #AACR18
ThNks to he 21stcentury cures act, patient reported outcomes MUST be reviewed by @FDAOncology #AACRSSP18 #AACR18
November 19, 2024 at 1:57 AM
ThNks to he 21stcentury cures act, patient reported outcomes MUST be reviewed by @FDAOncology #AACRSSP18 #AACR18
Dr Pazdur of @FDAOncology : who cares about what happens in the artificial environment of a clinical trial? We need to know how the drug will work in the real world.
#AACRSSP18 #AACR18
#AACRSSP18 #AACR18
November 19, 2024 at 1:57 AM
Dr Pazdur of @FDAOncology : who cares about what happens in the artificial environment of a clinical trial? We need to know how the drug will work in the real world.
#AACRSSP18 #AACR18
#AACRSSP18 #AACR18
Dr Pardoll: Rick Pazdur of @FDAOncology has been instrumental in accelerating the pace of approval in the immunotherapy space and deserves major kudos for this.
#AACRSSP18 #AACR18
#AACRSSP18 #AACR18
November 19, 2024 at 1:56 AM
Dr Pardoll: Rick Pazdur of @FDAOncology has been instrumental in accelerating the pace of approval in the immunotherapy space and deserves major kudos for this.
#AACRSSP18 #AACR18
#AACRSSP18 #AACR18
Thank you @tmprowell for facilitating a meeting with @FDAOncology. To say we were overwhelmed - and grateful - to see all you there is an understatement. Thank you all for listening
November 19, 2024 at 1:34 AM
Thank you @tmprowell for facilitating a meeting with @FDAOncology. To say we were overwhelmed - and grateful - to see all you there is an understatement. Thank you all for listening
Dr Gary Lyman: @FDAOncology should consider drug prices (which will require congressional direction/approval). CMS needs to be able to negotiate prices. More competition to decrease prices . #SCHD18
November 19, 2024 at 12:13 AM
Dr Gary Lyman: @FDAOncology should consider drug prices (which will require congressional direction/approval). CMS needs to be able to negotiate prices. More competition to decrease prices . #SCHD18
.@FDAOncology pilot RTOR (Real-Time Oncology Review) is a way to identify problems with a NDA before the official application is submitted, allowing feedback to improve the application and avoid unnecessary delays #AAADV19
November 18, 2024 at 6:39 PM
.@FDAOncology pilot RTOR (Real-Time Oncology Review) is a way to identify problems with a NDA before the official application is submitted, allowing feedback to improve the application and avoid unnecessary delays #AAADV19
The only disadvantage of knowing wonderful @FDAOncology folks like @drjennifergao is that they call on you for questions or comments! #AAADV19
November 18, 2024 at 6:39 PM
The only disadvantage of knowing wonderful @FDAOncology folks like @drjennifergao is that they call on you for questions or comments! #AAADV19
Director of @FDAOncology Oncology Center of Excellence @realrickpazdur educating #Advocates about the newly launched Project Facilitate to help local oncs through the #CompassionateUse process. #ASCO19
November 18, 2024 at 5:49 PM
Director of @FDAOncology Oncology Center of Excellence @realrickpazdur educating #Advocates about the newly launched Project Facilitate to help local oncs through the #CompassionateUse process. #ASCO19