Compared to Comprehensive Genomic Profiling (CGP), single-gene assays are limited to a single biomarker. In contrast, #CGP uncovers many mutations while scanning genomes for multiple biomarkers.

#Genomics #PrecisionMedicine #FDAODAC #ngs #mutations #Cancer #cancerfreeindia

9/4 ➡️“Pembrolizumab provides a valuable treatment option for patients with BCG-unresponsive NMIBC with CIS who are ineligible for or decline RC, a clinical scenario for which no well-accepted treatment options are currently available.” #FDAODAC #bladdercancer

Today the FDA Oncologic Drugs Advisory Committee voted 12-0 in favor of using minimal residual disease as an accelerated approval endpoint in multiple myeloma clinical trials.
Meeting info: fda.gov/advisory-commi…
Watch: youtube.com/watch?v=pooME9…

#FDAODAC

Be a part of the exciting session by Dr. Pramod Kumar Julka to know how #PrecisionOncology is bringing revolution and setting new standards for personalized cancer care.

Register Now: 4basecare.com/poareg/

#Genomics #PrecisionMedicine #CancerEducation #FDAODAC #Illumina #DNA

#FDAODAC unanimously voted to maintain pembro monotherapy approval in 2L #HCC after KEYNOTE 240 miss. Awaiting 2L confirmatory KEYNOTE 394 (anticipated mid-2021), and LEAP002 (1L lenvatinib + pembro, anticipated 2022)

As and National Breast Cancer Coalition advocate, I am disappointed in the #FDAODAC vote.

#mmMRD #mmsm #FDAODAC

#FDA schedules Feb 9 advisory panel review for #dostarlimab , submitted by GlaxoSmithKline, for proposed use as monotherapy in patients with mismatch repair deficiency/microsatellite instability-high locally advanced rectal cancer. $GSK #FDA ODAC #adcomm

public-inspection.federalregister.gov/2022-27834.pdf

FYI: 5 years of votes made by #FDA ’s oncology drugs advisory committee #ODAC #FDA ODAC

FDA ADCOMM VOTE (with picture of members' votes): Does the demonstrated benefit of ( $GSK #Belamaf ) #belantamab mafodotin outweigh the risks in the proposed patient population* with multiple myeloma?
12-Yes
0-No
0-Abstain
2 non-voting
#FDAODAC #BCMA

ICYMI: Watch the FDA Oncologic Drugs Advisory Committee discussion of minimal residual disease as an endpoint in multiple myeloma clinical trials.
Meeting info: fda.gov/advisory-commi…
Watch: youtube.com/watch?v=pooME9…

#FDAODAC

Great presentations and discussions at #FDAODAC today!

Key #FDAodac excerpts in pics
Tl;dr FDA isn’t for withdrawal of FOLOTYN (pralatrexate) & BELEODAQ (belinostat) but will ask the committee to discuss strategies for timely completion of confirmatory PMRs.

Today #FDAODAC will vote on whether to recommend approval of 131I-omburtamab solution for injection, by Y-mAbs Therapeutics, proposed for neuroblastoma w/ central nervous system/leptomeningeal metastases $YMAB
Stream youtu.be/Oh3QdmodNK8%EF…
Docs, times EDT fda.gov/advisory-commi…

Very big #FDAODAC learning opportunity here for all Oncologists/Trainees. Any one interested in Drug Development and Regulatory Science.

Highly recommend reading the joint Briefing Package for the Pepaxto (melphalan flufenamide).
fda.gov/media/161678/d…

Start at page 10.

#FDAodac meeting slide: Recent Oncology Trials Exhibit Lack of Correlation
All meeting documents: fda.gov/advisory-commi…

SITC is pleased to present this report on the April 28, 2021, meeting of the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC). #FDAODAC #atezolizumab #pembrolizumab

You can view the report on our blog, The Sentinel. blog.sitcancer.org/2021/04/sitc-m…

In April, the Oncologic Drug Advisory Committee (ODAC) voted 7-2 to keep atezolizumab on the market for advanced/metastatic triple-negative breast cancer. National Breast Cancer Coalition was disappointed with this but not surprised. Read our recap. #FDAODAC stopbreastcancer.org/call-to-action…

Meeting materials are now available for the Oct. 28 Oncologic Drugs Advisory Committee meeting. #FDAODAC
fda.gov/advisory-commi…

New treatments for #myeloma may be approved earlier for US patients: FDA’s ODAC approved Minimal Residual Disease ( #MRD ) as an early endpoint for accelerated approval last Friday.

MPE prepared a Q&A on this: mpeurope.org/2024/04/18/qa-…

#FDAODAC #oncology