U.S. FDA Approves IMBRUVICA ® (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL)
HORSHAM, Pa., April 21, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who are new to therapy. The approval is based on positive results from the landmark Phase 3 E1912 study that was designed and conducted by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute, part of the National Institutes of Health. Today’s milestone mar...
Source: Johnson and Johnson - April 22, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Roche announces CHMP recommendation for EU approval of Venclyxto plus Gazyvaro for people with untreated chronic lymphocytic leukaemia
Basel, 31 January 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency ’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Venclyxto® (venetoclax) in combination with Gazyvaro® (obinutuzumab) for the treatment of adults with previously untreated chronic lymphocytic leukaemia (CLL).“Despite advances in treating chronic lymphocytic leukaemia, many patients cannot tolerate the side effects of chemotherapy-containing regimens,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We’r...
Source: Roche Investor Update - January 31, 2020 Category: Pharmaceuticals Source Type: news

European Commission approves Roche ’s Polivy for people with previously treated aggressive lymphoma
Roche today announced that the European Commission has granted conditional marketing authorisation for Polivy ® (polatuzumab vedotin), in combination with bendamustine plus MabThera® (rituximab) (BR), for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not candidates for a haematopoietic stem cell transplant. (Source: Roche Investor Update)
Source: Roche Investor Update - January 21, 2020 Category: Pharmaceuticals Source Type: news

European Commission approves Roche ’s Polivy for people with previously treated aggressive lymphoma
Roche today announced that the European Commission has granted conditional marketing authorisation for Polivy ® (polatuzumab vedotin), in combination with bendamustine plus MabThera® (rituximab) (BR), for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not candidates for a haematopoietic stem cell transplant. (Source: Roche Media News)
Source: Roche Media News - January 21, 2020 Category: Pharmaceuticals Source Type: news

Diego Villa, MD, FRCPC, Discusses Bendamustine and Rituximab as Induction Therapy in MCL
Diego Villa, MD, FRCPC, elaborated on the progress made with bendamustine and rituximab as induction therapy for transplant eligible and ineligible patients with mantle cell lymphoma. (Source: CancerNetwork)
Source: CancerNetwork - January 3, 2020 Category: Cancer & Oncology Authors: Diego Villa, MD, FRCPC Source Type: news

John M. Pagel, MD, PhD, on Polatuzumab Vedotin
The Swedish Cancer Center expert discussed the addition of polatuzumab vedotin to a bendamustine-rituximab regimen at the ASH Annual Meeting& Exposition. (Source: CancerNetwork)
Source: CancerNetwork - December 13, 2019 Category: Cancer & Oncology Authors: John M. Pagel, MD, PhD Source Type: news

CHMP recommends conditional EU approval of Roche ’s Polivy for people with previously treated aggressive lymphoma
Roche today announced that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Polivy ® (polatuzumab vedotin) in combination with bendamustine plus MabThera® (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who are not candidates for a haematopoietic stem cell transplant. (Source: Roche Media News)
Source: Roche Media News - November 15, 2019 Category: Pharmaceuticals Source Type: news

CHMP recommends conditional EU approval of Roche ’s Polivy for people with previously treated aggressive lymphoma
Roche today announced that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Polivy ® (polatuzumab vedotin) in combination with bendamustine plus MabThera® (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who are not candidates for a haematopoietic stem cell transplant. (Source: Roche Investor Update)
Source: Roche Investor Update - November 15, 2019 Category: Pharmaceuticals Source Type: news

Belrapzo (Bendamustine Hydrochloride Injection) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 8, 2019 Category: Drugs & Pharmacology Source Type: news

Could Adding Bortezomib Have Benefit for High-Risk Follicular Lymphoma?
The CALGB 50904 trial tested the addition of bortezomib to ofatumumab and bendamustine in patients with previously untreated high-risk follicular lymphoma. (Source: CancerNetwork)
Source: CancerNetwork - June 25, 2019 Category: Cancer & Oncology Authors: Leah Lawrence Source Type: news

FDA grants Roche's Polivy accelerated approval for people with previously treated aggressive lymphoma
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Polivy™ (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan® (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least two prior therapies. (Source: World Pharma News)
Source: World Pharma News - June 13, 2019 Category: Pharmaceuticals Tags: Featured Roche Business and Industry Source Type: news

Polivy Chemoimmunotherapy Regimen Approved to Treat DLBCL
TUESDAY, June 11, 2019 -- Polivy (polatuzumab vedotin-piiq), a novel antibody-drug conjugate, received approval to treat patients with diffuse large B-cell lymphoma (DLBCL) in combination with bendamustine and rituximab, the U.S. Food and Drug... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - June 11, 2019 Category: General Medicine Source Type: news

FDA grants Roche ’s Polivy accelerated approval for people with previously treated aggressive lymphoma
Roche today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Polivy ™ (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan® (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least two prior therapies. (Source: Roche Investor Update)
Source: Roche Investor Update - June 11, 2019 Category: Pharmaceuticals Source Type: news

FDA grants Roche ’s Polivy accelerated approval for people with previously treated aggressive lymphoma
Roche today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Polivy ™ (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan® (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least two prior therapies. (Source: Roche Media News)
Source: Roche Media News - June 11, 2019 Category: Pharmaceuticals Source Type: news

FDA Approves Polatuzumab Yedotin-Piiq Combination for DLBCL Patients
The FDA granted accelerated approval to polatuzumab vedotin-piiq, a CD79b-directed antibody-drug conjugate, in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma. (Source: CancerNetwork)
Source: CancerNetwork - June 11, 2019 Category: Cancer & Oncology Authors: Erin Kayata Source Type: news