The FDA raises concerns over early deaths in CAR-T myeloma trials involving J&J, Legend, and Bristol Myers. The agency is debating whether these deaths should impact plans for Abecma and Carvykti. Meanwhile, the FDA approves expanded use of Mirum's liver disease drug and requires boxed warnings for all CAR T-cell therapies.
FDA ODAC Committee Votes Unanimously in Favor of Benefit-Risk Profile of Cilta-Cel in Early R/R Myeloma https://t.co/wygBesUVLq via @onclive
Bristol Myers cell therapy wins first-of-its-kind approval https://t.co/E8AGysp9V7 $BMY by @realJacobBell
Bristol Myers cell therapy wins first-of-its-kind approval https://t.co/Ud8y4myfes vby @realJacobBell $BMY $ALLO
Geron’s stock soars 95% after FDA advisory panel votes in favor of blood-disorder drug https://t.co/jWCDIjX021
$GERN up 85%. Here's my take on yesterday's imetelstat adcom, via @ApexOnco -> https://t.co/fC9yRxaKLA
Our look at yesterday's #ODAC result ... #Pinksheet #pharma: Imetelstat Scores Positive ODAC Nod Thanks To Quality Of Life Improvement https://t.co/vrQYqLP5dl
Seconds away, round two. Let's hope today's $JNJ $LEGN $BMY $TSVT BCMA adcom is more interesting that the $GERN one yesterday. https://t.co/ZZYNtmm9VT
While CAR-T treatments from Bristol Myers Squibb's Celgene Corp. and J&J's Janssen Biotech each improved progression-free survival in myeloma trials, FDA in briefing documents flagged concerns about an increased risk of early death from adverse events. https://t.co/F7spdVDSVb
Bristol Myers Squibb cell therapy gets FDA green light to treat common type of leukemia https://t.co/gZOFbfCI1M
Safety risks hang over CAR-T therapies for myeloma https://t.co/heTqeDIgTo @TreedinDC
$BMY FDA Approves Breyanzi as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma
Imetelstat Scores Positive ODAC Nod Thanks To Quality Of Life Improvement https://t.co/0UHNMTOWm4 #PinkSheet
$BGNE BeiGene Receives FDA Approval for TEVIMBRA® for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Prior Chemotherapy - https://t.co/9qSDDCnkiD It is its its first US clearance after a series of setbacks
FDA approves first drug for common form of liver inflammation | Click on the image to read the full story https://t.co/3u9AgKeawD
US FDA expands use of Bristol Myers' cancer therapy https://t.co/YPb2mxfmIS https://t.co/64DbdX9mQa
Bristol Myers won accelerated approval for the first CAR-T therapy for adults with two forms of hard-to-treat leukemia or lymphoma https://t.co/kGBIwb1rqd
A West Conshohocken biotech firm won FDA approval on Thursday for the first drug aimed at treating a common liver disease that has soared amid the obesity epidemic. https://t.co/xMOViJNdZQ
FDA Approves Lisocabtagene Maraleucel for Relapsed or Refractory CLL or SLL https://t.co/0MOBCjLNw6 via @onclive
Proud to share the FDA approved our PD-1 inhibitor for the treatment of advanced or metastatic esophageal squamous cell carcinoma (#ESCC) after prior chemotherapy. This is the first approval of this medicine in the U.S. and an important part of our efforts to help more patients. https://t.co/RmnPIFnaDZ
US FDA approves BeiGene's esophageal cancer therapy https://t.co/DZo7klTVoA https://t.co/fU1WbbCmw8
An advisory committee has just greenlighted a Bay Area company's drug for blood cancer patients. Here's the latest. https://t.co/ziIgtLXITb
FDA Approves Tislelizumab for Advanced or Metastatic ESCC After Chemotherapy https://t.co/0QMK5QVVxX via @onclive
BREAKING: @US_FDA Approves Tislelizumab for Advanced or Metastatic ESCC After Chemotherapy #esocsm #oncology https://t.co/CHlrBg83mJ https://t.co/SzzaIsXw2G
FDA not thrilled with Carvikti and Abecma data https://t.co/473Zuz6rTT
So satisfying to watch live the #ODAC meeting (at 4 AM Kyoto 🇯🇵 time where I am at #MDSsm meeting) & see vast majority of panel recognize the benefits over risks of #imetelstat based on our pivotal #IMerge trial, & look forward to having the drug approved for our patients! https://t.co/mzYlmqcNXk
Geron's blood disorder drug gets FDA advisers' backing https://t.co/AhOxz5ZlhQ
Voting Question: Benefits of imetelstat outweigh risks for transfusion dependent anemia in MDS who have not responded or lost response or ineligible for erythropoiesis-stimulating agents? #odac Y: 12 N: 2 A: 0
Moving to the imetelstat voting question... #odac
Now moving to @US_FDA presentation on imetelstat #odac ...
Is CAR-T safe for early-stage patients? FDA reviewers have some concerns, according to documents related to a pair of cancer medicines from Johnson & Johnson and Bristol Myers Squibb. https://t.co/i1x9YQyHIz
FDA says clinical trial findings create uncertainty about benefit-risk for patients who would otherwise receive supportive care only #odac
The @US_FDA introductory comments on Geron's imetelstat going over most of the efficacy and safety questions the agency raised. #odac
Also this ... #Pinksheet #pharma: US FDA Seeks More Power To Confront ‘Shadow’ Factory Challenges https://t.co/IdOjBHgx32
For your adcomm reform radar ... #Pinksheet #Pharma: US FDA Wants Advisory Committee Duty To Be ‘Enjoyable’ https://t.co/lizji5lpYu
More adcomm prep ... #pinksheet #Pharma #odac: BMS And J&J CAR-Ts Flagged For Early Deaths Ahead of Back-To-Back FDA Advisory Panels https://t.co/jshRZmiq8v
The FDA will now require boxed warnings—the highest safety-related caution for medications—for all CAR T-cell therapies. Read this report to learn how these blood #cancer treatments may pose a risk of secondary cancers. #MedicalNews https://t.co/ooidrfu6na https://t.co/K2QsDYkeEx
Everyone ready for the $GERN imetelstat adcom? https://t.co/uxwzeVC6c5
US FDA Wants Advisory Committee Duty To Be ‘Enjoyable’ https://t.co/dzTNivBTOz #PinkSheet
US FDA approves expanded use of Mirum's liver disease drug https://t.co/8pnj6l2tGm https://t.co/rVKUArNGqO
BCMA CAR Ts: Are short-term risks worth long-term gains? @US_FDA’s ODAC to debate whether early deaths should derail plans for Abecma, Carvykti in earlier treatment lines $BMY $JNJ $LEGN https://t.co/F13PZXsJgT
US FDA staff raise concerns over data from J&J, Bristol's CAR-T therapies https://t.co/UTwnvqUujV
FDA flags early deaths in CAR-T myeloma trials for J&J and Legend’s Carvykti, Bristol Myers’ Abecma https://t.co/e1qVbMD6IB
Multiple myeloma Car-Ts face a US grilling $JNJ $LEGN $BMY $TSVT https://t.co/1cdRTUnIfk