US FDA accepts Biocon's cancer drug application for review
Biocon and Mylan ’s proposed biosimilar bevacizumab, a cancer drug, is expected to be the third biosimilar from the partnered portfolio for patients in the US. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - March 8, 2020 Category: Pharmaceuticals Source Type: news
FDA grants Breakthrough Therapy Designation for Roche ’s Esbriet (pirfenidone) in unclassifiable interstitial lung disease
Basel, 3 March 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to Esbriet ® (pirfenidone) for adults with unclassifiable interstitial lung disease (uILD). The designation was granted based on data from a Phase II trial, which studied the efficacy and safety of Esbriet in uILD[1]. The study represented the first randomised controlled trial to exclusively enroll patients with progressive fibrosing uILD.“Today’s milestone for Esbriet builds on our continued commitment to improving the standard of care for people ...
Source: Roche Investor Update - March 3, 2020 Category: Pharmaceuticals Source Type: news
China National Medical Products Administration grants approval of Roche ’s Tecentriq in combination with chemotherapy as first-line treatment of people with extensive-stage small cell lung cancer
Basel, 14 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that China National Medical Products Administration (NMPA) has approved Tecentriq® (atezolizumab) in combination with chemotherapy (carboplatin and etoposide) for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).“Small cell lung cancer is an area of major unmet need in China and one that has seen limited advances until now,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “This approval makes Tecentriq the first cancer immunotherapy available in China...
Source: Roche Investor Update - February 14, 2020 Category: Pharmaceuticals Source Type: news
China National Medical Products Administration grants approval of Roche ’s Tecentriq in combination with chemotherapy as first-line treatment of people with extensive-stage small cell lung cancer
Basel, 14 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that China National Medical Products Administration (NMPA) has approved Tecentriq® (atezolizumab) in combination with chemotherapy (carboplatin and etoposide) for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).“Small cell lung cancer is an area of major unmet need in China and one that has seen limited advances until now,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “This approval makes Tecentriq the first cancer immunotherapy available in China...
Source: Roche Media News - February 14, 2020 Category: Pharmaceuticals Source Type: news
Roche to present new data on Tecentriq in combination with Avastin that shows improvement in overall survival for Chinese patients with the most common form of liver cancer
Basel, 7 February 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that additional data will be presented from a cohort of Chinese patients in the Phase III IMbrave150 study that evaluated Tecentriq ® (atezolizumab) in combination with Avastin® (bevacizumab) as a treatment for people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. Data from 194 Chinese patients who took part in the IMbrave150 study were consistent with the global results, that showed a statistically significant and clinically meaningful improvement in overall survival (OS) and progression-free survi...
Source: Roche Investor Update - February 7, 2020 Category: Pharmaceuticals Source Type: news
QoL Extended With Atezolizumab + Bevacizumab in Liver Cancer
And, triplet and doublet drug regimens delay decline in quality of life in BRAF V600E metastatic CRC (Source: The Doctors Lounge - Oncology)
Source: The Doctors Lounge - Oncology - January 29, 2020 Category: Cancer & Oncology Tags: Gastroenterology, Oncology, Pharmacy, Conference News, Source Type: news
QoL Extended With Atezolizumab & #43; Bevacizumab in Liver Cancer
WEDNESDAY, Jan. 29, 2020 -- For patients with unresectable hepatocellular carcinoma, the combination of atezolizumab and bevacizumab is associated with longer time to deterioration of patient-reported quality of life (QOL); and decline in... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 29, 2020 Category: Pharmaceuticals Source Type: news
New Drug Combo Potentially Practice Changing in Advanced HCC New Drug Combo Potentially Practice Changing in Advanced HCC
Atezolizumab plus bevacizumab was superior to sorafenib for maintaining quality of life in patients with unresectable hepatocellular carcinoma (HCC).Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - January 27, 2020 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news
Roche submits supplemental Biologics License Application to the FDA for Tecentriq in combination with Avastin for the most common form of liver cancer
·Application is being reviewed under FDA ’s Real-Time Oncology Review pilot programmeBasel, 27 January 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the completion of a supplemental Biologics License Application (sBLA) submission to the US Food and Drug Administration (FDA) for Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab), for the treatment of people with unresectab le hepatocellular carcinoma (HCC) who have not received prior systemic therapy. The FDA is reviewing the application under the Real-Time Oncology Review pilot programme, which aims to explore a more efficient...
Source: Roche Investor Update - January 27, 2020 Category: Pharmaceuticals Source Type: news
Roche submits supplemental Biologics License Application to the FDA for Tecentriq in combination with Avastin for the most common form of liver cancer
Roche today announced the completion of a supplemental Biologics License Application (sBLA) submission to the US Food and Drug Administration (FDA) for Tecentriq ® (atezolizumab) in combination with Avastin® (bevacizumab), for the treatment of people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. (Source: Roche Media News)
Source: Roche Media News - January 27, 2020 Category: Pharmaceuticals Source Type: news
Genentech Submits sBLA for Atezolizumab Plus Bevacizumab Combo to Treat Unresectable HCC
The company ’s application is based on results from the phase III IMbrave150 study of the regimen for the treatment of patients with unresectable hepatocellular carcinoma who have not received prior systemic therapy. (Source: CancerNetwork)
Source: CancerNetwork - January 27, 2020 Category: Cancer & Oncology Authors: Hannah Slater Source Type: news
Atezolizumab in Combination with Bevacizumab May Be Effective for Patients with HCC
High-quality patient reported outcomes were observed, suggesting benefits in key aspects of the patient experience with this combination treatment. (Source: CancerNetwork)
Source: CancerNetwork - January 22, 2020 Category: Cancer & Oncology Authors: Hannah Slater Source Type: news
Activation of Apelin Signaling Decreases VEGF Inhibitor Efficacy in Ovarian Cancer Treatment
A recent study suggested the activation of apelin/APJ signaling decreased efficacy in VEGF treatment, while bevacizumab decreased disease-free survival rates with increased expression of apelin in patients of ovarian cancer. (Source: CancerNetwork)
Source: CancerNetwork - January 21, 2020 Category: Cancer & Oncology Authors: Matthew Fowler Source Type: news
Peer Influence May Lead to Subsequent Physician Adoption
In this study, researchers looked at the adoption and use of bevacizumab in order to identify opportunities to increase use of high-value therapies. (Source: CancerNetwork)
Source: CancerNetwork - January 16, 2020 Category: Cancer & Oncology Authors: Hannah Slater Source Type: news
Lynparza regulatory submission granted Priority Review in the US for 1st-line maintenance treatment with bevacizumab in advanced ovarian cancer
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) announced that a supplemental New Drug Application for Lynparza (olaparib) in combination with bevacizumab has been accepted and granted Priority Review in the US for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to 1st-line platinum-based chemotherapy with bevacizumab. (Source: World Pharma News)
Source: World Pharma News - January 15, 2020 Category: Pharmaceuticals Tags: Featured AstraZeneca Business and Industry Source Type: news
