FDA、進行性透明細胞型腎細胞がんにベルズチファンとレンバチニブ併用療法を承認
FDAは2026年9月、PD-1またはPD-L1阻害剤治療後に疾患が進行した進行性透明細胞型腎細胞がん（ccRCC）の成人患者に対し、ベルズチファン（Welireg）とレンバチニブ（Lenvima）の併用療法を承認した。この承認は、カボザンチニブ（Cabometyx）に対する優越性を示した第3相LITESPARK-011試験（NCT04586231）の結果に基づいている。
出典: urologytimes.com
FDAは2026年9月、PD-1またはPD-L1阻害剤治療後に疾患が進行した進行性透明細胞型腎細胞がん（ccRCC）の成人患者に対し、ベルズチファン（Welireg）とレンバチニブ（Lenvima）の併用療法を承認した。この承認は、カボザンチニブ（Cabometyx）に対する優越性を示した第3相LITESPARK-011試験（NCT04586231）の結果に基づいている。
出典: urologytimes.com
FDA、進行性透明細胞型腎細胞がんにベルズチファンとレンバチニブ併用療法を承認
FDAは2026年9月、PD-1またはPD-L1阻害剤治療後に疾患が進行した進行性透明細胞型腎細胞がん（ccRCC）の成人患者に対し、ベルズチファン（Welireg）とレンバチニブ（Lenvima）の併用療法を承認した。この承認は、カボザンチニブ（Cabometyx）に対する優越性を示した第3相LITESPARK-011試験（NCT04586231）の結果に基づいている。試験では747人の患者がラ
www.urologytimes.com
October 1, 2026 at 8:10 AM
FDA、進行性透明細胞型腎細胞がんにベルズチファンとレンバチニブ併用療法を承認
FDAは2026年9月、PD-1またはPD-L1阻害剤治療後に疾患が進行した進行性透明細胞型腎細胞がん（ccRCC）の成人患者に対し、ベルズチファン（Welireg）とレンバチニブ（Lenvima）の併用療法を承認した。この承認は、カボザンチニブ（Cabometyx）に対する優越性を示した第3相LITESPARK-011試験（NCT04586231）の結果に基づいている。
出典: urologytimes.com
FDAは2026年9月、PD-1またはPD-L1阻害剤治療後に疾患が進行した進行性透明細胞型腎細胞がん（ccRCC）の成人患者に対し、ベルズチファン（Welireg）とレンバチニブ（Lenvima）の併用療法を承認した。この承認は、カボザンチニブ（Cabometyx）に対する優越性を示した第3相LITESPARK-011試験（NCT04586231）の結果に基づいている。
出典: urologytimes.com
Kidney cancer progressed after immunotherapy? 🧬
FDA approved belzutifan (Welireg®) + lenvatinib (Lenvima®) on Sept 28 for advanced clear cell RCC after PD-1/PD-L1 therapy: the first HIF-2α inhibitor + VEGFR-TKI combo for these patients.
#KidneyCancer #RCC #Oncology #ChinaOnlinePharmacy
FDA approved belzutifan (Welireg®) + lenvatinib (Lenvima®) on Sept 28 for advanced clear cell RCC after PD-1/PD-L1 therapy: the first HIF-2α inhibitor + VEGFR-TKI combo for these patients.
#KidneyCancer #RCC #Oncology #ChinaOnlinePharmacy
September 30, 2026 at 7:48 AM
Kidney cancer progressed after immunotherapy? 🧬
FDA approved belzutifan (Welireg®) + lenvatinib (Lenvima®) on Sept 28 for advanced clear cell RCC after PD-1/PD-L1 therapy: the first HIF-2α inhibitor + VEGFR-TKI combo for these patients.
#KidneyCancer #RCC #Oncology #ChinaOnlinePharmacy
FDA approved belzutifan (Welireg®) + lenvatinib (Lenvima®) on Sept 28 for advanced clear cell RCC after PD-1/PD-L1 therapy: the first HIF-2α inhibitor + VEGFR-TKI combo for these patients.
#KidneyCancer #RCC #Oncology #ChinaOnlinePharmacy
FDA approves belzutifan in combination with lenvatinib for advanced RCC with a clear cell component
https://cancerletter.com/drugs-and-targets/20260925_10b/
https://cancerletter.com/drugs-and-targets/20260925_10b/
FDA approves belzutifan in combination with lenvatinib for advanced RCC with a clear cell component - The Cancer Letter
FDA has approved belzutifan (Welireg) in combination with lenvatinib (Lenvima) for adults with advanced renal cell carci
cancerletter.com
September 27, 2026 at 6:00 PM
FDA approves belzutifan in combination with lenvatinib for advanced RCC with a clear cell component
https://cancerletter.com/drugs-and-targets/20260925_10b/
https://cancerletter.com/drugs-and-targets/20260925_10b/
FDA-heavy Friday: Lilly's once-weekly insulin Onswik and Merck's Welireg-Lenvima kidney combo cleared, Novo pays $1.3B to Nanexa, Nektar wins $90M from Lilly, and the biotech IPO window keeps widening.
https://openbionews.com/analysis/daily-bio-news-summary-2026-09-25/
https://openbionews.com/analysis/daily-bio-news-summary-2026-09-25/
Daily Bio News Summary — 2026-09-25: Lilly
Seventeen items from BioSpace, Fierce Pharma, Fierce Biotech and BioPharma Dive: FDA approvals for Lilly
openbionews.com
September 26, 2026 at 2:01 AM
FDA-heavy Friday: Lilly's once-weekly insulin Onswik and Merck's Welireg-Lenvima kidney combo cleared, Novo pays $1.3B to Nanexa, Nektar wins $90M from Lilly, and the biotech IPO window keeps widening.
https://openbionews.com/analysis/daily-bio-news-summary-2026-09-25/
https://openbionews.com/analysis/daily-bio-news-summary-2026-09-25/
🚨 BREAKING: #$MRK just won FDA approval for WELIREG plus LENVIMA to treat advanced renal cell carcinoma, improving progression-free survival by 26%. 19 analysts have rated it in the past year: 16 at buy, 3 at hold, with targets from $120 to $180.
September 25, 2026 at 11:01 AM
🚨 BREAKING: #$MRK just won FDA approval for WELIREG plus LENVIMA to treat advanced renal cell carcinoma, improving progression-free survival by 26%. 19 analysts have rated it in the past year: 16 at buy, 3 at hold, with targets from $120 to $180.
FDA approved Belzutifan + Lenvatinib for advanced kidney cancer after immunotherapy. In a trial (747 pts), it extended time before cancer worsened to 14.6 vs 10.6 months. What does an extra 4 months of stable disease truly mean for these patients?
FDA Approves Belzutifan in Combination with Lenvatinib for Advanced Kidney Cancer Post-Immunotherapy
The U.S. Food and Drug Administration (FDA) has approved a new combination treatment consisting of belzutifan (Welireg) and lenvatinib (Lenvima) for adults battling advanced renal cell carcinoma, a ty
www.fda.gov
September 25, 2026 at 8:02 AM
FDA approved Belzutifan + Lenvatinib for advanced kidney cancer after immunotherapy. In a trial (747 pts), it extended time before cancer worsened to 14.6 vs 10.6 months. What does an extra 4 months of stable disease truly mean for these patients?
FDA clears Welireg, Lenvima for post-immunotherapy kidney cancer #$MRK #$ESALF firstwordpharma.com/story/8097145
September 25, 2026 at 12:17 AM
FDA clears Welireg, Lenvima for post-immunotherapy kidney cancer #$MRK #$ESALF firstwordpharma.com/story/8097145
The FDA has approved belzutifan (Welireg) in combination with lenvatinib (Lenvima) for the treatment of adult patients with advanced clear cell renal cell carcinoma (ccRCC) following progression on a PD-1 or PD-L1 inhibitor. #kidneycancer
www.cancernetwork.com/view/belzuti...
www.cancernetwork.com/view/belzuti...
Belzutifan Combo Receives FDA Approval in Advanced Clear Cell RCC | CancerNetwork
Data from the phase 3 LITESPARK-011 trial support the FDA approval of belzutifan plus lenvatinib for adults with advanced clear cell renal cell carcinoma.
www.cancernetwork.com
September 24, 2026 at 9:35 PM
The FDA has approved belzutifan (Welireg) in combination with lenvatinib (Lenvima) for the treatment of adult patients with advanced clear cell renal cell carcinoma (ccRCC) following progression on a PD-1 or PD-L1 inhibitor. #kidneycancer
www.cancernetwork.com/view/belzuti...
www.cancernetwork.com/view/belzuti...
Moi, j’ai commencé le Lenvima (à vie 😞) en traitement de confort. Je me garde le choix de l’arrêter si ça enlève sur ma qualité de vie restante.
Tellement contente pour toi!!! 🥹
Tellement contente pour toi!!! 🥹
August 13, 2026 at 8:04 PM
Moi, j’ai commencé le Lenvima (à vie 😞) en traitement de confort. Je me garde le choix de l’arrêter si ça enlève sur ma qualité de vie restante.
Tellement contente pour toi!!! 🥹
Tellement contente pour toi!!! 🥹
Eisai Expands Clinical Data for LENVIMA at ASCO 2026, Showcasing Advances in Oncology Treatments#USA#Chicago#oncology#Eisai#LENVIMA
Eisai Expands Clinical Data for LENVIMA at ASCO 2026, Showcasing Advances in Oncology Treatments
Eisai highlights new clinical findings for LENVIMA at ASCO 2026, addressing various cancer treatments and patient populations with groundbreaking research.
third-news.com
May 20, 2026 at 12:57 PM
Important data from the LITESPARK-012 trial: while the triplet combo didn’t beat KEYTRUDA plus LENVIMA on primary endpoints, every result in science shapes what comes next for kidney cancer patients. www.merck.com/news/merck-a... #Carcinoma #OncologyTrials #KidneyCancer #ClinicalTrials #TCSC
Merck and Eisai Provide Update on Phase 3 LITESPARK-012 Trial Evaluating First-Line Combination Treatments for Certain Patients With Advanced Renal Cell Carcinoma (RCC) - Merck.com
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today announced results from the Phase 3 LITESPARK-012 trial evaluating combination regimens for the first-line treat...
www.merck.com
April 22, 2026 at 7:38 PM
Important data from the LITESPARK-012 trial: while the triplet combo didn’t beat KEYTRUDA plus LENVIMA on primary endpoints, every result in science shapes what comes next for kidney cancer patients. www.merck.com/news/merck-a... #Carcinoma #OncologyTrials #KidneyCancer #ClinicalTrials #TCSC
Addition of Welireg fails to improve efficacy of Keytruda, Lenvima regimen in first-line RCC #$MRK firstwordpharma.com/story/7191498
April 21, 2026 at 12:31 PM
Addition of Welireg fails to improve efficacy of Keytruda, Lenvima regimen in first-line RCC #$MRK firstwordpharma.com/story/7191498
#MRK Merck and Eisai Provide Update on Phase 3 LITESPARK-012 Trial Evaluating First-Line Combination Treatments for Certain Patients With Advanced Renal Cell Carcinoma (RCC)
https://www.stocktitan.net/news/MRK/merck-and-eisai-provide-update-on-phase-3-litespark-012-trial-r38a8u3ich2n.html
https://www.stocktitan.net/news/MRK/merck-and-eisai-provide-update-on-phase-3-litespark-012-trial-r38a8u3ich2n.html
Two kidney cancer drug combos fail to beat Merck's standard therapy
At an interim analysis, neither regimen improved progression-free or overall survival versus Keytruda plus Lenvima. Full data review is ongoing.
www.stocktitan.net
April 21, 2026 at 10:45 AM
#MRK Merck and Eisai Provide Update on Phase 3 LITESPARK-012 Trial Evaluating First-Line Combination Treatments for Certain Patients With Advanced Renal Cell Carcinoma (RCC)
https://www.stocktitan.net/news/MRK/merck-and-eisai-provide-update-on-phase-3-litespark-012-trial-r38a8u3ich2n.html
https://www.stocktitan.net/news/MRK/merck-and-eisai-provide-update-on-phase-3-litespark-012-trial-r38a8u3ich2n.html
The company is going to provide a year of Lenvima at no cost!
#FrightClub
Wait... does this mean I have to stop shit talking drug companies?
#FrightClub
Wait... does this mean I have to stop shit talking drug companies?
a man and a woman are jumping in the air in a living room .
ALT: a man and a woman are jumping in the air in a living room .
media.tenor.com
April 2, 2026 at 5:01 PM
The company is going to provide a year of Lenvima at no cost!
#FrightClub
Wait... does this mean I have to stop shit talking drug companies?
#FrightClub
Wait... does this mean I have to stop shit talking drug companies?
#Eisai #digitalplatform #kidneycancerpatients #kidneycancer #digitaldestination #Kompass #kidneycancerdiagnosis #KidneyCancerKompass #patientorganisations #KCCure #KidneyCAN #KidneyCancerAssociation #NationalKidneyFoundation #Lenvima #lenvatinib #MSD #renalcellcarcinoma #RCC
zurl.co/qpSNo
zurl.co/qpSNo
Eisai unveils digital platform for kidney cancer patients
Eisai has launched a 'digital destination', called Kompass, that aims to support patients after they have been given a diagnosis of kidney cancer.
pharmaphorum.com
April 1, 2026 at 9:14 AM
This weekend we're reading about Keytruda and Lenvima. Trying to guess which side effects to prepare for. Jay's happy he might get to keep his hair and I desperately want him to shave it!
March 22, 2026 at 6:01 AM
This weekend we're reading about Keytruda and Lenvima. Trying to guess which side effects to prepare for. Jay's happy he might get to keep his hair and I desperately want him to shave it!
Advanced kidney cancer got a hopeful boost. A new combo reduced disease progression/death by 30%—that's like 3 more people out of 10 seeing cancer slow down after immunotherapy stopped working. FDA is reviewing.
WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) Reduces Risk of Disease Progression or Death by 30%
A Phase 3 clinical trial (LITESPARK-011) has shown that a combination of WELIREG and LENVIMA significantly reduced the risk of disease progression or death by 30% in patients with advanced renal cell
www.eisai.com
March 2, 2026 at 8:01 AM
Advanced kidney cancer got a hopeful boost. A new combo reduced disease progression/death by 30%—that's like 3 more people out of 10 seeing cancer slow down after immunotherapy stopped working. FDA is reviewing.
Feed: "Endpoints News"
By: Nicole DeFeudis on Saturday, February 28, 2026
By: Nicole DeFeudis on Saturday, February 28, 2026
Merck looks to expand Welireg label following combo readouts with Keytruda, Lenvima
Merck seeks approval for Welireg combinations in kidney cancer, showing disease progression benefits but awaiting clear survival data in studies with Lenvima and Keytruda.
endpoints.news
February 28, 2026 at 11:09 PM
Feed: "Endpoints News"
By: Nicole DeFeudis on Saturday, February 28, 2026
By: Nicole DeFeudis on Saturday, February 28, 2026
Black Americans face higher rates of liver disease and liver cancer. CMS’s latest Medicare drug negotiation list matters: Lenvima (liver cancer) is included. Last year’s cycle added Xifaxan for hepatic encephalopathy. Prices take effect 2027–2028. Learn more at www.aasld.org/policy-commu...
February 24, 2026 at 6:00 PM
Black Americans face higher rates of liver disease and liver cancer. CMS’s latest Medicare drug negotiation list matters: Lenvima (liver cancer) is included. Last year’s cycle added Xifaxan for hepatic encephalopathy. Prices take effect 2027–2028. Learn more at www.aasld.org/policy-commu...
Whew! My latest PET scan shows no evidence of disease! My previous scans 3 months ago were inconclusive due to a lot of inflammation, But 3 months off the Keytruda/Lenvima combo, it’s resolved! I get 3 more months without tests, scans or visits! #cansky #oncosky #endometrialcancer
February 20, 2026 at 9:25 PM
Whew! My latest PET scan shows no evidence of disease! My previous scans 3 months ago were inconclusive due to a lot of inflammation, But 3 months off the Keytruda/Lenvima combo, it’s resolved! I get 3 more months without tests, scans or visits! #cansky #oncosky #endometrialcancer
2/3big pharma doesn’t want you to know about it.” He’s also “self medicating” with: Keytruda, Lenvima(sp?), fenbendazole,mebendazole.Says not taking “chemo pills” causes gut ‘biome’ to “revert to normal”, cancer “confined to liver & 2 abdominal lymph nodes & diaphragm muscle” Doc is trying to -
February 17, 2026 at 5:48 PM
2/3big pharma doesn’t want you to know about it.” He’s also “self medicating” with: Keytruda, Lenvima(sp?), fenbendazole,mebendazole.Says not taking “chemo pills” causes gut ‘biome’ to “revert to normal”, cancer “confined to liver & 2 abdominal lymph nodes & diaphragm muscle” Doc is trying to -
CMS: DRUGS SELECTED FOR THIRD CYCLE OF MEDICARE PRICE NEGOTIATIONS INCLUDE ENTYVIO, ERLEADA, KISQALI, LENVIMA, ORENCIA, ANORO ELLIPTA, BIKTARVY, BOTOX, BOTOX COSMETIC, CIMZIA, COSENTYX.
January 27, 2026 at 9:41 PM
CMS: DRUGS SELECTED FOR THIRD CYCLE OF MEDICARE PRICE NEGOTIATIONS INCLUDE ENTYVIO, ERLEADA, KISQALI, LENVIMA, ORENCIA, ANORO ELLIPTA, BIKTARVY, BOTOX, BOTOX COSMETIC, CIMZIA, COSENTYX.