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US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche ’s Tecentriq for PD-L1-positive, metastatic triple-negative breast cancer
This study did not meet its primary endpoint of PFS for the initial (first-line) treatment of people with mTNBC in the PD-L1-positive population. As the clinically meaningful benefit demonstrated in the IMpassion130 study remains, Roche looks forward to continuing to work with the FDA to determine next steps with regard to Tecentriq in this indication.Roche remains committed to following the science to better understand cancer, including which patients may benefit most from immunotherapy treatment. Tecentriq has already demonstrated its transformational role in areas of high medical need and is a first in class medicine ap...
Source: Roche Investor Update - April 27, 2021 Category: Pharmaceuticals Source Type: news

US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche ’s Tecentriq for PD-L1-positive, metastatic triple-negative breast cancer
This study did not meet its primary endpoint of PFS for the initial (first-line) treatment of people with mTNBC in the PD-L1-positive population. As the clinically meaningful benefit demonstrated in the IMpassion130 study remains, Roche looks forward to continuing to work with the FDA to determine next steps with regard to Tecentriq in this indication.Roche remains committed to following the science to better understand cancer, including which patients may benefit most from immunotherapy treatment. Tecentriq has already demonstrated its transformational role in areas of high medical need and is a first in class medicine ap...
Source: Roche Media News - April 27, 2021 Category: Pharmaceuticals Source Type: news

Janssen Provides Update on Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA ® (apalutamide) and ZYTIGA® (abiraterone acetate) Plus Prednisone Combination
RARITAN, N.J., April 19, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that regulatory submissions based on the Phase 3 ACIS study, which evaluated the combination of ERLEADA® (apalutamide) and ZYTIGA® (abiraterone acetate) plus prednisone in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC), will not be pursued. As presented at the American Society of Clinical Oncology’s Genitourinary (ASCO GU) Cancers Symposium in February 2021, the ACIS study met its primary endpoint of radiographic progression-free survival (rPFS); however, combination...
Source: Johnson and Johnson - April 19, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Adjuvant Nivolumab Beneficial in Esophageal, GE Junction Cancer
THURSDAY, April 1, 2021 -- Among patients with resected esophageal or gastroesophageal junction cancer who have received neoadjuvant chemoradiotherapy, disease-free survival is significantly longer with nivolumab adjuvant therapy versus placebo,... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 1, 2021 Category: Pharmaceuticals Source Type: news

Roche receives positive CHMP opinion for Tecentriq as a first-line monotherapy treatment for people with a type of metastatic non-small cell lung cancer
Basel, 26 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq® (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression*, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations. Based on this recommendation, a final decision regarding the approval of Tecentriq in this disease setting, along with the full details of the ...
Source: Roche Investor Update - March 26, 2021 Category: Pharmaceuticals Source Type: news

Roche receives positive CHMP opinion for Tecentriq as a first-line monotherapy treatment for people with a type of metastatic non-small cell lung cancer
Basel, 26 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq® (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression*, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations. Based on this recommendation, a final decision regarding the approval of Tecentriq in this disease setting, along with the full details of the ...
Source: Roche Media News - March 26, 2021 Category: Pharmaceuticals Source Type: news

Pivotal Phase III study shows Roche ’s Tecentriq helped people with early lung cancer live longer without their disease returning
Basel, 22 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMpower010 study evaluating Tecentriq® (atezolizumab), compared with best supportive care (BSC), met its primary endpoint of disease-free survival (DFS) at the interim analysis. Tecentriq showed a statistically significant im provement in DFS as adjuvant therapy following surgery and chemotherapy in all randomised Stage II-IIIA populations with non-small cell lung cancer (NSCLC). The magnitude of DFS benefit was particularly pronounced in the PD-L1-positive population. Follow-up will continue with planned analyses of DFS in the ...
Source: Roche Investor Update - March 22, 2021 Category: Pharmaceuticals Source Type: news

Pivotal Phase III study shows Roche ’s Tecentriq helped people with early lung cancer live longer without their disease returning
Basel, 22 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMpower010 study evaluating Tecentriq® (atezolizumab), compared with best supportive care (BSC), met its primary endpoint of disease-free survival (DFS) at the interim analysis. Tecentriq showed a statistically significant im provement in DFS as adjuvant therapy following surgery and chemotherapy in all randomised Stage II-IIIA populations with non-small cell lung cancer (NSCLC). The magnitude of DFS benefit was particularly pronounced in the PD-L1-positive population. Follow-up will continue with planned analyses of DFS in the ...
Source: Roche Media News - March 22, 2021 Category: Pharmaceuticals Source Type: news

Age Should Not Prevent Aggressive Esophageal Cancer Treatment Age Should Not Prevent Aggressive Esophageal Cancer Treatment
Neoadjuvant chemoradiation plus esophagectomy can be performed safely in well-selected older patients with locally advanced esophageal or esophagogastric junction cancer, according to a reviewMedscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - March 2, 2021 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news

Optimal Therapy for Esophageal Cancer Feasible in Fit Elderly
FRIDAY, Feb. 26, 2021 -- Patients 70 years and older with locally advanced esophageal or esophagogastric junction (EGJ) cancer should be considered for optimal, potentially curative therapy, including neoadjuvant chemoradiotherapy and surgical... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - February 26, 2021 Category: Pharmaceuticals Source Type: news

Janssen Announces Treatment with ERLEADA ® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer
RARITAN, N.J., February 8, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today results from the final analysis of the Phase 3 TITAN study, which demonstrated the continued statistically significant benefit of the addition of ERLEADA® (apalutamide) to androgen deprivation therapy (ADT) in overall survival (OS) in patients with metastatic castration-sensitive prostate cancer (mCSPC), regardless of extent of disease, when compared to placebo plus ADT.[1] Results will be featured in an oral presentation at the American Society of Clinical Oncology’s Genitourinary (ASCO GU) Cancers Symposiu...
Source: Johnson and Johnson - February 8, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA ® (apalutamide) and ZYTIGA® (abiraterone acetate) Combination
RARITAN, N.J., February 8, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today results from the randomized, double-blind, placebo-controlled Phase 3 ACIS study, which met the primary endpoint of radiographic progression-free survival (rPFS) with a 31 percent reduction in the risk of radiographic progression or death in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) receiving androgen deprivation therapy (ADT). Patients in the trial received either a combination of ERLEADA® and ZYTIGA® plus prednisone (combination arm) or placebo and ZYTIGA® pl...
Source: Johnson and Johnson - February 8, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen to Highlight Robust Solid Tumor Portfolio and Pipeline at 2021 ASCO GU
February 2, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it will highlight the depth of its solid tumor portfolio at the American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium with 12 data presentations, including three company-sponsored oral presentations from the ERLEADA® (apalutamide) clinical development program. The virtual meeting will take place February 11-13, 2021. “We are committed to the development of innovative therapies for patients with genitourinary cancers for whom there remains a high unmet need,” said Craig Tendler, M...
Source: Johnson and Johnson - February 2, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Higher Intensity Therapy and Surgical Risk in Esophageal Cancer Higher Intensity Therapy and Surgical Risk in Esophageal Cancer
Combining standard neoadjuvant chemotherapy for locally advanced esophageal cancer with either radiation or docetaxel did not increase the risk of surgical complications, investigators in the JCOG1109 trial reported.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - January 29, 2021 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news

Early Breast Cancer Highlights From SABCS 2020 Early Breast Cancer Highlights From SABCS 2020
Highlights in early breast cancer from SABCS 2020 include data indicating that more HR+ women can skip adjuvant chemotherapy, and neoadjuvant atezolizumab does not worsen quality of life in early TNBC.Medscape (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 31, 2020 Category: Consumer Health News Tags: Hematology-Oncology ReCAP Source Type: news