Merck, Astellas and Pfizer bring down the house with Keytruda-Padcev FDA nod in bladder cancer
The combination therapy was hailed with a standing ovation in October at the European Society for Medical Oncology (ESMO) conference in Madrid. Less than two months later, the FDA has added its acclaim—blessing it five months ahead of its PDUFA date. On Friday the U.S. regulator signed off on…#fda #pfizerspadcev #merck #keytruda #seagen #ahsanarozullah #rogerdansey #pfizer #padcev #pd1 (Source: Reuters: Health)
Source: Reuters: Health - December 19, 2023 Category: Consumer Health News Source Type: news
US FDA approves Astellas' combination therapy for bladder cancer
(Source: Reuters: Health)
Source: Reuters: Health - December 16, 2023 Category: Consumer Health News Source Type: news
FDA Approves New First-Line Standard of Care in Bladder Cancer
(MedPage Today) -- Patients with locally advanced or metastatic bladder cancer have a permanent new first-line standard of care after the FDA granted full approval to the combination of enfortumab vedotin (Padcev) and pembrolizumab (Keytruda) regardless... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - December 16, 2023 Category: American Health Source Type: news
Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer
Padcev plus pembrolizumab approved based on groundbreaking EV-302 trial
Confirmatory trial found Padcev plus pembrolizumab nearly doubled median overall survival compared to standard of care platinum-based chemotherapy
TOKYO and NEW YORK, Dec.... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 15, 2023 Category: Drugs & Pharmacology Source Type: news
Motorist fined £88 for 'littering' when he was caught WEEING in a layby gets penalty overturned... after proving he has a weak bladder (and now the 69-year-old vows to keep a receptacle in his car in case of another emergency!)
Michael Mason, 69, from Winslow, Bucks, was fined £88 for 'littering' after weeing in a layby. But a £30 letter from the GP to prove he has prostate cancer saw the fine binned. (Source: the Mail online | Health)
Source: the Mail online | Health - December 7, 2023 Category: Consumer Health News Source Type: news
First Gene Therapy for Non-Muscle-Invasive Bladder Cancer Offers Durable Response
(MedPage Today) -- WASHINGTON -- The gene therapy nadofaragene firadenovec (Adstiladrin) continued to demonstrate clinical activity in patients with high-risk bladder cancer, researchers reported.
The long-term follow-up data came from a phase... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - December 4, 2023 Category: Hematology Source Type: news
Oncolytic Virus Shows High Response Rates in BCG-Unresponsive Bladder Cancer
(MedPage Today) -- WASHINGTON -- Treatment with cretostimogene grenadenorepvec, an investigational intravesically delivered oncolytic immunotherapy, achieved high response rates in patients with high-risk non-muscle-invasive bladder cancer (NMIBC... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - December 1, 2023 Category: Hematology Source Type: news
Noninvasive Therapy Shows Efficacy in Non-Muscle-Invasive Bladder Cancer
(MedPage Today) -- WASHINGTON -- An investigational non-surgical treatment led to a "robust" complete response rate in patients with recurrent, low-grade non-muscle-invasive bladder cancer, the phase III ENVISION study showed.
Patients treated... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - November 30, 2023 Category: Hematology Source Type: news
Development and validation of a nomogram for predicting suicide risk and prognostic factors in bladder cancer patients following diagnosis: a population-based retrospective study - Liu L, Xiao Y, Wei D, Wang Q, Zhang JK, Yuan L, Bai GQ.
This study sought to identify independent risk factors associated with suicide following a diagnosis of bladder cancer and to develop a predictive model with the potential to contribute to suicide rate reduction. Harnessing data from the Surveillance, Epid... (Source: SafetyLit)
Source: SafetyLit - November 27, 2023 Category: International Medicine & Public Health Tags: Research Methods, Surveillance and Codes, Models Source Type: news
Roche ’s subcutaneous injection of Tecentriq recommended by the EU’s CHMP for multiple cancer types
If approved, Tecentriq subcutaneous (SC) would be the first injectable PD-(L)1 cancer immunotherapy in the EU, cutting treatment time by approx. 80%1 The CHMP recommended Tecentriq SC for all indications of intravenous (IV) Tecentriq, including certain types of lung, liver, bladder and breast cancer2A majority of healthcare professionals surveyed in the IMscin001 study found that the SC formulation is easy to administer and could save time compared with IV1Basel, 14 November 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency ’s Committee for Medicinal Products for Human Use (C...
Source: Roche Investor Update - November 14, 2023 Category: Pharmaceuticals Source Type: news
Roche ’s subcutaneous injection of Tecentriq recommended by the EU’s CHMP for multiple cancer types
If approved, Tecentriq subcutaneous (SC) would be the first injectable PD-(L)1 cancer immunotherapy in the EU, cutting treatment time by approx. 80%1 The CHMP recommended Tecentriq SC for all indications of intravenous (IV) Tecentriq, including certain types of lung, liver, bladder and breast cancer2A majority of healthcare professionals surveyed in the IMscin001 study found that the SC formulation is easy to administer and could save time compared with IV1Basel, 14 November 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency ’s Committee for Medicinal Products for Human Use (C...
Source: Roche Media News - November 14, 2023 Category: Pharmaceuticals Source Type: news
Pioneering trial will test DNA in the TUMOURS of patients with advanced bladder cancer - allowing doctors to prescribe personalised drug treatments
A pioneering UK trial will allow patients with advanced bladder cancer to receive personalised drug treatments depending on the DNA in their tumours. (Source: the Mail online | Health)
Source: the Mail online | Health - November 11, 2023 Category: Consumer Health News Source Type: news
Landmark Trial Produces New First-Line Standard for Advanced Bladder Cancer
(MedPage Today) -- MADRID -- Chemotherapy's generation-long dominance in first-line advanced urothelial cancer ended with a resounding victory for the antibody-drug conjugate (ADC) enfortumab vedotin (Padcev) plus pembrolizumab (Keytruda) in... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - October 22, 2023 Category: Hematology Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche reports good sales growth despite decline in demand for COVID-19 products
Basel, 19 October 2023Groupsales grow by 1%1at constant exchange rates (CER) in the first nine months, showing a strong increase of 7% in the third quarterExcluding COVID-19 products,Group salesincrease by 9%Pharmaceuticals Division sales grow by 9%, driven by continued high demand for newer medicinesDiagnostics Division ’s base businessincreases by 7%;overall divisional sales are down 18% due to a surge in demand for COVID-19 tests in 2022Highlightsin the third quarter of 2023:EU approval ofEvrysdifor babies under two months old with spinal muscular atrophyFirst approval of subcutaneous form of cancer immunotherapyTecen...
Source: Roche Media News - October 19, 2023 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche reports good sales growth despite decline in demand for COVID-19 products
Groupsales grow by 1%1at constant exchange rates (CER) in the first nine months, showing a strong increase of 7% in the third quarterExcluding COVID-19 products,Group salesincrease by 9%Pharmaceuticals Division sales grow by 9%, driven by continued high demand for newer medicinesDiagnostics Division ’s base businessincreases by 7%;overall divisional sales are down 18% due to a surge in demand for COVID-19 tests in 2022Highlightsin the third quarter of 2023:EU approval ofEvrysdifor babies under two months old with spinal muscular atrophyFirst approval of subcutaneous form of cancer immunotherapyTecentriqPositive phase III...
Source: Roche Investor Update - October 19, 2023 Category: Pharmaceuticals Source Type: news
