【イミフィンジとPADCEVの周術期、米で優先審査】
AstraZenecaなどのVOLGA（695例）。シスプラチン化学療法が適応外、または希望しない筋層浸潤膀胱がん。周術期のデュルバルマブと術前エンホルツマブ ベドチンで、無イベント生存と全生存が有意に延びた。FDA優先審査。PDUFAは2026年第4四半期。承認そのものではない。
Imfinzi＋EVの周術期併用療法、米国で優先審査指定──VOLGA第3相で無イベント生存・全生存を有意に改善
stellanews.life/technology/1...
AstraZenecaなどのVOLGA（695例）。シスプラチン化学療法が適応外、または希望しない筋層浸潤膀胱がん。周術期のデュルバルマブと術前エンホルツマブ ベドチンで、無イベント生存と全生存が有意に延びた。FDA優先審査。PDUFAは2026年第4四半期。承認そのものではない。
Imfinzi＋EVの周術期併用療法、米国で優先審査指定──VOLGA第3相で無イベント生存・全生存を有意に改善
stellanews.life/technology/1...
Imfinzi＋EVの周術期併用療法、米国で優先審査指定──VOLGA第3相で無イベント生存・全生存を有意に改善
AstraZeneca社は、durvalumab（Imfinzi）とenfortumab vedotin併用による周術期治療の適応追加申請が、筋層浸潤性膀胱がん患者を対象に米国FDAで優先審査に指定されたと発表した。VOLGA第3相試験の中間解析で無イベント生存期間と全生存期間の有意な改善が示されたことが根拠となっている。
stellanews.life
September 28, 2026 at 4:11 AM
【イミフィンジとPADCEVの周術期、米で優先審査】
AstraZenecaなどのVOLGA（695例）。シスプラチン化学療法が適応外、または希望しない筋層浸潤膀胱がん。周術期のデュルバルマブと術前エンホルツマブ ベドチンで、無イベント生存と全生存が有意に延びた。FDA優先審査。PDUFAは2026年第4四半期。承認そのものではない。
Imfinzi＋EVの周術期併用療法、米国で優先審査指定──VOLGA第3相で無イベント生存・全生存を有意に改善
stellanews.life/technology/1...
AstraZenecaなどのVOLGA（695例）。シスプラチン化学療法が適応外、または希望しない筋層浸潤膀胱がん。周術期のデュルバルマブと術前エンホルツマブ ベドチンで、無イベント生存と全生存が有意に延びた。FDA優先審査。PDUFAは2026年第4四半期。承認そのものではない。
Imfinzi＋EVの周術期併用療法、米国で優先審査指定──VOLGA第3相で無イベント生存・全生存を有意に改善
stellanews.life/technology/1...
My operation was on my 66th bday. I have a double nephrostomy(not from bladder cancer, but from undiagnosed high blood pressure killed off my kidneys) so I could only do immunotherapy: Padcev & Keytruda. My oncologist Dr. Saqib Abbasi at KU Cancer Center told me the best we could hope for was
September 27, 2026 at 8:55 PM
My operation was on my 66th bday. I have a double nephrostomy(not from bladder cancer, but from undiagnosed high blood pressure killed off my kidneys) so I could only do immunotherapy: Padcev & Keytruda. My oncologist Dr. Saqib Abbasi at KU Cancer Center told me the best we could hope for was
glede vprašanja KaJ pA sPlOh LaHkO gLeDaMo Na TvS, lahko recimo pogledate igorjev dokumentarec o tem, kako sta dva modela ob pomoči fabrike prikolic ratala prva slovenska kompetitivna solo oceanska jadralca. ažo danes fura first linijo performance bark za beneteau. 365.rtvslo.si/arhiv/dokume...
September 25, 2026 at 4:50 PM
glede vprašanja KaJ pA sPlOh LaHkO gLeDaMo Na TvS, lahko recimo pogledate igorjev dokumentarec o tem, kako sta dva modela ob pomoči fabrike prikolic ratala prva slovenska kompetitivna solo oceanska jadralca. ažo danes fura first linijo performance bark za beneteau. 365.rtvslo.si/arhiv/dokume...
Merck $MRK: periop MIBC EFS via KEYTRUDA+Padcev shfits HTA; buy now.
September 20, 2026 at 8:01 PM
Merck $MRK: periop MIBC EFS via KEYTRUDA+Padcev shfits HTA; buy now.
Merck $MRK: CHMP EFS win alters HTA; ADC+mRAN offsets cliff. Buy, analysi. https://investingnews.com/merck-receives-positive-eu-chmp-opinion-for-keytruda-r-plus-padcev-r-as-perioperative-treatment-for-adults-with-resectable-muscle-invasive-bladder-cancer/
September 20, 2026 at 2:05 PM
Merck $MRK: CHMP EFS win alters HTA; ADC+mRAN offsets cliff. Buy, analysi. https://investingnews.com/merck-receives-positive-eu-chmp-opinion-for-keytruda-r-plus-padcev-r-as-perioperative-treatment-for-adults-with-resectable-muscle-invasive-bladder-cancer/
【PADCEV併用、筋層浸潤膀胱がんでCHMPが肯定的意見】
切除可能な筋層浸潤性膀胱がんのうち、シスプラチン適格例。再発・進行・死亡のリスクが47％低下した、との整理。CHMPの肯定的意見であり、販売承認ではない。
PADCEV併用療法、切除可能な筋層浸潤性膀胱がんでCHMP肯定的意見──シスプラチン適格例で再発・進行・死亡リスクを47%低減
stellanews.life/technology/1...
切除可能な筋層浸潤性膀胱がんのうち、シスプラチン適格例。再発・進行・死亡のリスクが47％低下した、との整理。CHMPの肯定的意見であり、販売承認ではない。
PADCEV併用療法、切除可能な筋層浸潤性膀胱がんでCHMP肯定的意見──シスプラチン適格例で再発・進行・死亡リスクを47%低減
stellanews.life/technology/1...
PADCEV併用療法、切除可能な筋層浸潤性膀胱がんでCHMP肯定的意見──シスプラチン適格例で再発・進行・死亡リスクを47%低減
AstellasとMerck（MSD）は、PADCEV（enfortumab vedotin）とKeytruda（pembrolizumab）併用の周術期治療について、シスプラチン適格の切除可能な筋層浸潤性膀胱がん患者を対象にCHMPが肯定的意見を採択したと発表した。第3相EV-304試験に基づく。
stellanews.life
September 20, 2026 at 5:53 AM
【PADCEV併用、筋層浸潤膀胱がんでCHMPが肯定的意見】
切除可能な筋層浸潤性膀胱がんのうち、シスプラチン適格例。再発・進行・死亡のリスクが47％低下した、との整理。CHMPの肯定的意見であり、販売承認ではない。
PADCEV併用療法、切除可能な筋層浸潤性膀胱がんでCHMP肯定的意見──シスプラチン適格例で再発・進行・死亡リスクを47%低減
stellanews.life/technology/1...
切除可能な筋層浸潤性膀胱がんのうち、シスプラチン適格例。再発・進行・死亡のリスクが47％低下した、との整理。CHMPの肯定的意見であり、販売承認ではない。
PADCEV併用療法、切除可能な筋層浸潤性膀胱がんでCHMP肯定的意見──シスプラチン適格例で再発・進行・死亡リスクを47%低減
stellanews.life/technology/1...
Buy Merck; $MRK should rerate as ADC+mRNA pipeline offsets Keytruda patent cliff. Phase 3 EFS and CHMP momentum. https://investingnews.com/merck-receives-positive-eu-chmp-opinion-for-keytruda-r-plus-padcev-r-as-perioperative-treatment-for-adults-with-resectable-muscle-invasive-bladder-cancer/
September 18, 2026 at 5:02 PM
Buy Merck; $MRK should rerate as ADC+mRNA pipeline offsets Keytruda patent cliff. Phase 3 EFS and CHMP momentum. https://investingnews.com/merck-receives-positive-eu-chmp-opinion-for-keytruda-r-plus-padcev-r-as-perioperative-treatment-for-adults-with-resectable-muscle-invasive-bladder-cancer/
Padcev et Keytruda : Efficacité dans le traitement du cancer en France selon des études récentes.
Lire l'article complet sur : artia13.city
#artia13 #Santé
Lire l'article complet sur : artia13.city
#artia13 #Santé
Padcev et Keytruda : Efficacité dans le traitement du cancer en France selon des études récentes.
En 2023, l’association du Padcev et du Keytruda a marqué un tournant majeur dans la prise en charge des cancers de la vessie. C'est quoi exactement ? Comment agit cette combinaison ? Comment le traitement se déroule-t-il au quotidien ? Et à quels effets secondaires faut-il s'attendre ? On vous expli
www.artia13.city
September 10, 2026 at 7:13 AM
Padcev et Keytruda : Efficacité dans le traitement du cancer en France selon des études récentes.
Lire l'article complet sur : artia13.city
#artia13 #Santé
Lire l'article complet sur : artia13.city
#artia13 #Santé
Enfortumab vedotin (Padcev) is approved for use in a number of clinical indications, and Olson and Liu et al. recently returned to the preclinical setting to untangle its mechanism acir.org/weekly-dige...
September 9, 2026 at 4:30 PM
Enfortumab vedotin (Padcev) is approved for use in a number of clinical indications, and Olson and Liu et al. recently returned to the preclinical setting to untangle its mechanism acir.org/weekly-dige...
Lol, ravno včeraj mi je prijateljica govorila, kako so ji na urgenci sami sugerirali, da je padla na dvorišču. Uradna statistika padcev na dvoriščih in stopnicah mora biti kar zabavna.
September 1, 2026 at 5:25 AM
Lol, ravno včeraj mi je prijateljica govorila, kako so ji na urgenci sami sugerirali, da je padla na dvorišču. Uradna statistika padcev na dvoriščih in stopnicah mora biti kar zabavna.
Totalno beden lajf, dejansko potihem željno čakam odrešitev.
Ne bo 30+ letne divjajoče vsakodnevne bolečine, EPIjev in padcev ob napadih, dvojnih & trojnih težkih zlomov, trajnih posledic, vsakodnevnih skrbi kako prezivet naslednji dan ...
Kaj je veselje, sreča ... že dolgo, dolgo ne vem več 😔
Ne bo 30+ letne divjajoče vsakodnevne bolečine, EPIjev in padcev ob napadih, dvojnih & trojnih težkih zlomov, trajnih posledic, vsakodnevnih skrbi kako prezivet naslednji dan ...
Kaj je veselje, sreča ... že dolgo, dolgo ne vem več 😔
August 25, 2026 at 4:14 AM
Totalno beden lajf, dejansko potihem željno čakam odrešitev.
Ne bo 30+ letne divjajoče vsakodnevne bolečine, EPIjev in padcev ob napadih, dvojnih & trojnih težkih zlomov, trajnih posledic, vsakodnevnih skrbi kako prezivet naslednji dan ...
Kaj je veselje, sreča ... že dolgo, dolgo ne vem več 😔
Ne bo 30+ letne divjajoče vsakodnevne bolečine, EPIjev in padcev ob napadih, dvojnih & trojnih težkih zlomov, trajnih posledic, vsakodnevnih skrbi kako prezivet naslednji dan ...
Kaj je veselje, sreča ... že dolgo, dolgo ne vem več 😔
Ko otrok pade s kolesa ali se poškoduje pri igri, običajno ni hujših posledic. Včasih pa terjajo dolgotrajno zdravljenje ali rehabilitacijo, zato je nezgodno zavarovanje otroka, še posebej športnika, zelo smiselno. Pišite mi za informativno ponudbo. http://my.generali.social/d7CPcAtFj14d
Od padcev in ran do izplačila zavarovalnine v infografiki
my.generali.social
August 18, 2026 at 6:42 AM
Ko otrok pade s kolesa ali se poškoduje pri igri, običajno ni hujših posledic. Včasih pa terjajo dolgotrajno zdravljenje ali rehabilitacijo, zato je nezgodno zavarovanje otroka, še posebej športnika, zelo smiselno. Pišite mi za informativno ponudbo. http://my.generali.social/d7CPcAtFj14d
#Pfizer #Eliquis #BMS #pharmanews #Padcev #Astellas #Lorbrena #costsavings #costcuttinginitiatives #restructuring #BioNTech #COVID19vaccine #costofgoodssold #COGS #generics #bladdercancer #lungcancer #RandD #oncology #obesity #Metsera #patients #patentloss
zurl.co/LrplA
zurl.co/LrplA
Pfizer targets $2.5bn more in cost savings
Pfizer's second-quarter results update is headlined by news of an additional $2.5 billion in cost-cutting initiatives.
pharmaphorum.com
August 10, 2026 at 1:12 PM
It is 1 year to the day since I had my last chemo infusion. Padcev is a hell of a drug. Fucks you up but keeps you alive. My mind and body are just now starting to feel regulated. A long way to go but quite happy to be around for the journey.
July 28, 2026 at 5:59 PM
It is 1 year to the day since I had my last chemo infusion. Padcev is a hell of a drug. Fucks you up but keeps you alive. My mind and body are just now starting to feel regulated. A long way to go but quite happy to be around for the journey.
Ni samo mularija…problem je, da tudi starejši vozijo otroke ns skiroju, da s tem ogrožajo življenje…da sta oba brez čelade, da prihaja do padcev…
In potem to ni samo stvar policije ampak tudi tožilstva in sodišča, pa še kak CSD se vplete zaradi vpletenosti mld.
In potem to ni samo stvar policije ampak tudi tožilstva in sodišča, pa še kak CSD se vplete zaradi vpletenosti mld.
July 20, 2026 at 8:39 PM
Ni samo mularija…problem je, da tudi starejši vozijo otroke ns skiroju, da s tem ogrožajo življenje…da sta oba brez čelade, da prihaja do padcev…
In potem to ni samo stvar policije ampak tudi tožilstva in sodišča, pa še kak CSD se vplete zaradi vpletenosti mld.
In potem to ni samo stvar policije ampak tudi tožilstva in sodišča, pa še kak CSD se vplete zaradi vpletenosti mld.
Feed: "MashupMD"
By: Mashup MD on Sunday, July 19, 2026
By: Mashup MD on Sunday, July 19, 2026
FDA approves Padcev + Keytruda for muscle-invasive bladder cancer regardless of cisplatin eligibility – The Cancer Letter
Up-to-date medical news aggregated from trusted medical associations, journals, physicians and news outlets from around the world.
www.mashupmd.com
July 19, 2026 at 4:04 PM
Feed: "MashupMD"
By: Mashup MD on Sunday, July 19, 2026
By: Mashup MD on Sunday, July 19, 2026
FDA approves Padcev + Keytruda for muscle-invasive bladder cancer regardless of cisplatin eligibility
https://cancerletter.com/drugs-and-targets/20260717_10a/
https://cancerletter.com/drugs-and-targets/20260717_10a/
FDA approves Padcev + Keytruda for muscle-invasive bladder cancer regardless of cisplatin eligibility - The Cancer Letter
FDA approved Padcev (enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug conjugate, plus the PD-1 inhibitor Keytruda (pembrolizumab) or Keytruda QLEX (pembrolizumab and berahyaluronidase alfa-pmph), as neoadjuvant and adjuvant treatment for adult patients with muscle-invasive bladder cancer, regardless of cisplatin eligibility. To access this subscriber-only content please log in or subscribe.If your institution has a site license, […]
cancerletter.com
July 19, 2026 at 2:00 PM
FDA approves Padcev + Keytruda for muscle-invasive bladder cancer regardless of cisplatin eligibility
https://cancerletter.com/drugs-and-targets/20260717_10a/
https://cancerletter.com/drugs-and-targets/20260717_10a/
Dr. Peter O'Donnell is quoted in this SurvivorNet story about a newly approved bladder cancer treatment. www.survivornet.com/articles/new...
New Approval Means More Bladder Cancer Patients Can Access Powerful Immunotherapy Combination: What To Know About Keytruda + Padcev
A new treatment combination - Keytruda plus Padcev - is now approved for use before and after bladder‑removal surgery, offering a more effective option for many patients.
www.survivornet.com
July 17, 2026 at 4:13 PM
Dr. Peter O'Donnell is quoted in this SurvivorNet story about a newly approved bladder cancer treatment. www.survivornet.com/articles/new...
When Biological Indicators Don’t Fit: Rethinking Sterility Testing in Oncology Manufacturing
Pfizer validation engineer, peer-reviewed author, and ASTM Committee E55.06 voting member Prasantha Pujari on solving qualification challenges where biologics meet cytotoxic drugs — and why the frameworks…
Pfizer validation engineer, peer-reviewed author, and ASTM Committee E55.06 voting member Prasantha Pujari on solving qualification challenges where biologics meet cytotoxic drugs — and why the frameworks…
When Biological Indicators Don’t Fit: Rethinking Sterility Testing in Oncology Manufacturing
Pfizer validation engineer, peer-reviewed author, and ASTM Committee E55.06 voting member Prasantha Pujari on solving qualification challenges where biologics meet cytotoxic drugs — and why the frameworks he built for PADCEV are now published for the field Antibody-drug conjugate contract manufacturing hit $1.72 billion this year and will nearly... Read the full article on TechBullion.
news-area.com
July 16, 2026 at 9:59 PM
When Biological Indicators Don’t Fit: Rethinking Sterility Testing in Oncology Manufacturing
Pfizer validation engineer, peer-reviewed author, and ASTM Committee E55.06 voting member Prasantha Pujari on solving qualification challenges where biologics meet cytotoxic drugs — and why the frameworks…
Pfizer validation engineer, peer-reviewed author, and ASTM Committee E55.06 voting member Prasantha Pujari on solving qualification challenges where biologics meet cytotoxic drugs — and why the frameworks…
I've been watching $PFE and Pfizer: mRNA patent litigation plus an antibody-drug conjugate Phase 3 miss raise regulatory/legal tail risk. PADCEV FDA nod offsets near-term revenue; analysi. https://www.reuters.com/legal/litigation/sanofi-sues-pfizer-moderna-over-covid-shot-technology-2026-07-15/
July 16, 2026 at 11:03 AM
I've been watching $PFE and Pfizer: mRNA patent litigation plus an antibody-drug conjugate Phase 3 miss raise regulatory/legal tail risk. PADCEV FDA nod offsets near-term revenue; analysi. https://www.reuters.com/legal/litigation/sanofi-sues-pfizer-moderna-over-covid-shot-technology-2026-07-15/
FDA rejects Tris Pharma's narcolepsy drug; Agenus abandons its Phase 3 colorectal cancer program.
endpoints.news/tris-pharmas...
endpoints.news/tris-pharmas...
Tris Pharma's CRL for narcolepsy drug; Agenus abandons Phase 3 CRC trial
Tris Pharma's narcolepsy FDA rejection, Agenus's Phase 3 exit, plus Insilico, Ipsen, Q32 Bio, GSK, Drug Farm and Padcev news.
endpoints.news
July 13, 2026 at 8:07 PM
FDA rejects Tris Pharma's narcolepsy drug; Agenus abandons its Phase 3 colorectal cancer program.
endpoints.news/tris-pharmas...
endpoints.news/tris-pharmas...
Mon news: Top emerging biotech hubs. Padcev-Keytruda combo expands bladder cancer reach with FDA approval. FDA posts new CRLs days after confirming pause. GSK to file Jemperli for rectal cancer after phase 3 readout. —https://bit.ly/3JeBlY5
July 13, 2026 at 4:12 PM
Mon news: Top emerging biotech hubs. Padcev-Keytruda combo expands bladder cancer reach with FDA approval. FDA posts new CRLs days after confirming pause. GSK to file Jemperli for rectal cancer after phase 3 readout. —https://bit.ly/3JeBlY5