[Ad hoc announcement pursuant to Art. 53 LR] Phase III study shows Roche's Polivy plus R-CHP is the first regimen in 20 years to significantly improve outcomes in previously untreated aggressive form of lymphoma compared to standard of care
Basel, 9 August 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the pivotal phase III POLARIX trial investigating Polivy ® (polatuzumab vedotin) in combination with MabThera®/Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) versus MabThera/Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP), met its primary endpoint by demonstrating significantly improved an d clinically meaningful progression-free survival in people with previously untreated diffuse large B-cell lymphoma (DLBCL). Safety outcomes were consistent with those seen in previous trials.â...
Source: Roche Investor Update - August 9, 2021 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Phase III study shows Roche's Polivy plus R-CHP is the first regimen in 20 years to significantly improve outcomes in previously untreated aggressive form of lymphoma compared to standard of care
Basel, 9 August 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the pivotal phase III POLARIX trial investigating Polivy ® (polatuzumab vedotin) in combination with MabThera®/Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) versus MabThera/Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP), met its primary endpoint by demonstrating significantly improved an d clinically meaningful progression-free survival in people with previously untreated diffuse large B-cell lymphoma (DLBCL). Safety outcomes were consistent with those seen in previous trials.â...
Source: Roche Media News - August 9, 2021 Category: Pharmaceuticals Source Type: news
FDA grants Breakthrough Therapy Designation for Venclexta in combination with azacitidine for the treatment of patients with myelodysplastic syndromes
Basel, 21 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Venclexta ® (venetoclax) in combination with azacitidine has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated intermediate, high- and very high-risk myelodysplastic syndromes (MDS) based on the rev ised International Prognostic Scoring System (IPSS-R). MDS are a rare group of blood cancers that gradually affect the ability of the bone marrow to produce normal blood cells.2 This can lead to weakness, frequent infections, anaemia and deb...
Source: Roche Media News - July 21, 2021 Category: Pharmaceuticals Source Type: news
FDA grants Breakthrough Therapy Designation for Venclexta in combination with azacitidine for the treatment of patients with myelodysplastic syndromes
Basel, 21 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Venclexta ® (venetoclax) in combination with azacitidine has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated intermediate, high- and very high-risk myelodysplastic syndromes (MDS) based on the rev ised International Prognostic Scoring System (IPSS-R). MDS are a rare group of blood cancers that gradually affect the ability of the bone marrow to produce normal blood cells.2 This can lead to weakness, frequent infections, anaemia and deb...
Source: Roche Investor Update - July 21, 2021 Category: Pharmaceuticals Source Type: news
New Phase 3 Study Results Show IMBRUVICA ® (ibrutinib)-Based Combination Regimen as an All-Oral Fixed-Duration Treatment Demonstrated Superior Progression-Free Survival in Adult Patients with Previously Untreated Chronic Lymphocytic Leukemia
Raritan, N.J., June 12, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced primary results from the pivotal Phase 3 GLOW study (NCT03462719) evaluating fixed-duration IMBRUVICA® plus venetoclax (I+V) compared to chlorambucil plus obinutuzumab (Clb+O) for first-line treatment of elderly or unfit patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study demonstrated superior progression-free survival (PFS) of a once-daily, all-oral, fixed-duration regimen of I+V versus Clb+O as first-line treatment of CLL; the study also showed improved duration of re...
Source: Johnson and Johnson - June 12, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Janssen Highlights Commitment to Advancing Transformative Innovations in Oncology with Scientific Updates from Deep, Diverse Pipeline and Portfolio at ASCO and EHA Virtual Scientific Programs
June 1, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than 30 company-sponsored studies, including six oral presentations, will be featured during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, June 4-8. Janssen presentations will include new data and updates for both approved and investigational therapeutics that are being studied for the treatment of various solid tumors and blood cancers. Immediately following ASCO, additional data will be featured during the European Hematology Association (EHA) Virtual Congress, June 9-17. A comp...
Source: Johnson and Johnson - June 1, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
IMBRUVICA ® (ibrutinib)-Based Combination Regimen as a Fixed-Duration, First-Line Treatment for Chronic Lymphocytic Leukemia Demonstrates High Rates of Disease Control
May 19, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from the fixed-duration cohort of the investigational Phase 2 CAPTIVATE study, showing that 95 percent of patients treated with combined IMBRUVICA® plus venetoclax were alive and progression-free at two years.[1] Deep remissions were seen across all subgroups, including patients with high-risk chronic lymphocytic leukemia (CLL).1 In addition, long-term data from the RESONATE-2 (PCYC-1115/1116) study will be presented, providing the longest follow-up Phase 3 data for any BTK inhibitor to date. These data ...
Source: Johnson and Johnson - May 19, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Roche announces positive CHMP opinion for Venclyxto-based combinations in certain patients with acute myeloid leukaemia
Basel, 23 April 2021 - 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 a hypomethylating agent for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. Bas ed on this positive CHMP recommendation, a final decision regarding the approval of Venclyxto in certain patients with untreated AML is expected from the European Commission in the near future.“Today’s recommendation...
Source: Roche Investor Update - April 23, 2021 Category: Pharmaceuticals Source Type: news
New data presented at ASH 2020 reinforces the benefit/risk profile of fixed-duration Polivy plus bendamustine and MabThera/Rituxan in patients with relapsed or refractory diffuse large B-cell lymphoma
Basel, 07 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced longer-term data from the pivotal phase Ib/II GO29365 study, including data from a single-arm extension cohort of 106 additional patients, which show the benefit of Polivy ® (polatuzumab vedotin) plus bendamustine and MabThera®/Rituxan® (rituximab) (BR) in people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who are not eligible for stem cell transplant. Updated data from the randomised cohort (n=80) show that with longer follow-up (48.9 months) a complete response (CR) rate of 42.5% (n=17/40) was maintained in patien...
Source: Roche Investor Update - December 7, 2020 Category: Pharmaceuticals Source Type: news
New data presented at ASH 2020 reinforces the benefit/risk profile of fixed-duration Polivy plus bendamustine and MabThera/Rituxan in patients with relapsed or refractory diffuse large B-cell lymphoma
Basel, 07 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced longer-term data from the pivotal phase Ib/II GO29365 study, including data from a single-arm extension cohort of 106 additional patients, which show the benefit of Polivy ® (polatuzumab vedotin) plus bendamustine and MabThera®/Rituxan® (rituximab) (BR) in people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who are not eligible for stem cell transplant. Updated data from the randomised cohort (n=80) show that with longer follow-up (48.9 months) a complete response (CR) rate of 42.5% (n=17/40) was maintained in patien...
Source: Roche Media News - December 7, 2020 Category: Pharmaceuticals Source Type: news
New Data Demonstrate Long-Term Benefit of IMBRUVICA ® (ibrutinib) as First-Line Treatment for High-Risk Chronic Lymphocytic Leukemia
This study highlighted the need for cytogenetic/molecular testing before CIT treatment, consistent with clinical treatment guidelines.[8],[9]Real-World Prognostic Biomarker Testing, Treatment Patterns, And Dosing Among Patients With CLL/SLL From the informCLL™ Prospective Observational Registry (Abstract #547)An oral presentation on Monday, December 7, will feature results from the informCLL™ real-world prospective observational registry assessing treatment patterns in the era of novel agents.4 Key Study Findings:· The most common index treatment was IMBRUVICA®; the majority of patients treated with IMBRUVICA® remai...
Source: Johnson and Johnson - December 6, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news
Disease-Free Survival Data from CAPTIVATE Study Demonstrate Benefit of IMBRUVICA ® (ibrutinib)-Based Regimen as Fixed Duration, First-Line Treatment for Patients with Chronic Lymphocytic Leukemia
December 5, 2020 (RARITAN, N.J.) – New data from the Phase 2 CAPTIVATE study were presented today during an oral session at the 2020 American Society of Hematology (ASH) Annual Meeting (Abstract #123). The study evaluated the efficacy and safety of IMBRUVICA® (ibrutinib) plus venetoclax in the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and showed that, after achieving undetectable minimal residual disease (uMRD) in both the blood and bone marrow with the IMBRUVICA® combination regimen, the one-year disease-free survival (DFS) of patients randomized to discont...
Source: Johnson and Johnson - December 5, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news
Rates of VTE, Major Bleeding High in Primary CNS Lymphoma
FRIDAY, Nov. 20, 2020 -- For patients with primary central nervous system lymphoma (PCNSL), the incidence of venous thromboembolism (VTE) and major bleeding is high, according to a study published in the November issue of Leukemia&... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - November 20, 2020 Category: Pharmaceuticals Source Type: news
Janssen Headlines American Society of Hematology Annual Meeting With More Than 35 Presentations Highlighting Deep, Diverse Oncology Pipeline and Portfolio
RARITAN, N.J., November 5, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today more than 35 company-sponsored studies, including 10 oral presentations, will be featured at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition taking place virtually December 5-8, 2020.In multiple myeloma, highlights include Phase 1b/2 results for the B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor T-cell (CAR-T) therapy ciltacabtagene autoleucel (cilta-cel); new and updated data for the anti-CD38 monoclonal antibody DARZALEX® (daratumumab) and the subcutaneous for...
Source: Johnson and Johnson - November 5, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news
Incidence of VTE, Major Bleeding High in Primary CNS Lymphoma
MONDAY, June 29, 2020 -- The incidence of venous thromboembolism (VTE) and major bleeding is high among patients with primary central nervous system lymphoma (PCNSL), according to a study published online June 23 in Leukemia& Lymphoma.
Anjlee... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - June 29, 2020 Category: Pharmaceuticals Source Type: news
