Top Pharma News of the Week – June 25th

All The Most Important Pharmaceutical News Stories Of The Week – June 2018 – Week #4

New long-term data confirm Roche’s Gazyva/Gazyvaro extends the lives of people with chronic lymphocytic leukaemia compared to MabThera/Rituxan

June 15, 2018

Roche has announced data from the final analysis of the CLL11 study evaluating Gazyva®/Gazyvaro® (obinutuzumab)-based treatment in previously untreated chronic lymphocytic leukaemia (CLL). After a follow-up of nearly five years, final results showed clinically meaningful improvements with Gazyva/Gazyvaro plus chlorambucil across multiple endpoints, including progression-free survival (PFS) and overall survival (OS), when compared head-to-head with MabThera®/Rituxan® (rituximab) plus chlorambucil.

Novartis study of real-world data concludes Jakavi is associated with a reduction in risk of death and dangerous blood clots for patients with polycythemia vera

June 15, 2018

Novartis has announced results from a new comparison study showing that Jakavi®(ruxolitinib)-treated patients with polycythemia vera (PV), who were resistant or intolerant to hydroxyurea (HU), had a significantly reduced risk of thrombosis (blood clots) and death compared to PV patients who received best available therapy. The study findings are based on a comparison of patients in the Phase III RESPONSE Jakavi clinical trial and the real-world Spanish GEMFIN patient registry. PV is a rare and incurable blood cancer associated with an overproduction of blood cells that can cause serious cardiovascular complications, such as blood clots, stroke and heart attack.

Novartis JULIET trial of Kymriah demonstrates more than one-year durability of responses in adults with relapsed or refractory DLBCL

June 16, 2018

Novartis has announced 14-month results from the pivotal JULIET clinical trial showing ongoing durable responses are achievable with Kymriah® (tisagenlecleucel) when administered to adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). The overall response rate (ORR) was 52% (95% confidence interval [CI], 41% – 62%), among 93 evaluable patients who were followed for at least 3 months or discontinued earlier. A complete response (CR) was achieved in 40% of patients and 12% achieved a partial response (PR). Of the patients in CR at month 3, 83% remained in CR at month 12, and the median duration of response was not reached, indicating sustainability of response.

Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone Reduces the Risk of Disease Progression by 46% Versus Pomalidomide/Dexamethasone Alone in Patients with Relapsed or Refractory Multiple Myeloma

June 17, 2018

Bristol-Myers Squibb Company has announced that the ELOQUENT-3 trial, an international Phase 2 study evaluating the addition of Empliciti (elotuzumab) to pomalidomide and low-dose dexamethasone (EPd) in patients with relapsed/refractory multiple myeloma (RRMM), achieved its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for patients treated with EPd compared with pomalidomide and dexamethasone (Pd) alone. ELOQUENT-3 is the only randomized, active-controlled trial to investigate a pomalidomide-based triplet combination in patients with RRMM who received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI).

Roche and Foundation Medicine reach definitive merger agreement to accelerate broad availability of comprehensive genomic profiling in oncology

June 19, 2018

Roche and Foundation Medicine, Inc. have announced that they have entered into a definitive merger agreement for Roche to acquire the outstanding shares of FMI’s common stock not already owned by Roche and its affiliates at a price of US$ 137.00 per share in cash. This corresponds to a total transaction value of US$ 2.4 billion on a fully diluted basis, and a total company value of US$ 5.3 billion on a fully diluted basis. This price represents a premium of 29% to FMI’s closing price on 18 June 2018 and a premium of 47% and 68% to FMI’s 30-day and 90-day volume weighted average share price on 18 June 2018, respectively. The merger agreement has been unanimously approved by the board of Roche and a Special Committee of the independent directors of FMI and by its full board of directors.

U.S. Food and Drug Administration (FDA) Accepts Application for Opdivo Plus Low-Dose Yervoy for Treatment of First-Line Non-Small Cell Lung Cancer in Patients with Tumor Mutational Burden ?10 mut/Mb

June 21, 2018

Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) for the treatment of first-line advanced non-small cell lung cancer (NSCLC) in patients with tumor mutational burden (TMB) ?10 mutations per megabase (mut/Mb).

Oral semaglutide demonstrated significant reduction in blood sugar vs placebo in PIONEER

June 2018

Oral semaglutide, an investigational GLP-1 analogue taken as a once-daily tablet, achieved significant reductions in blood sugar versus placebo in adults with type 2 diabetes, according to findings from the PIONEER 1 phase 3a trial. The trial evaluated the efficacy and safety of 3, 7 and 14 mg oral semaglutide compared with placebo as monotherapy over 26 weeks in adults with type 2 diabetes.

Real-World Study of More than 700,000 People with Type 2 Diabetes (T2D) Shows No Increased Risk of Below-Knee Lower Extremity Amputations with INVOKANA (canagliflozin) Compared to Other Diabetes Medications

June 24, 2018

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced late-breaking results of a new real-world analysis of more than 700,000 U.S. T2D patients, which found no increased risk of below-knee lower extremity (BKLE) amputation with INVOKANA® (canagliflozin) compared to other sodium glucose cotransporter 2 inhibitors (SGLT2i) or non-SGLT2i anti-hyperglycemic medicines. In addition to the general T2D population, similar results were also seen in a sub-set of patients with T2D and established cardiovascular disease.

AbbVie and Calibr announce collaboration for next generation T-cell therapies

June 25, 2018

AbbVie, a research-based global biopharmaceutical company, and Calibr, a nonprofit drug discovery division of Scripps Research, have announced a collaboration to develop T-cell therapies aimed primarily at cancer, including solid tumors. This collaboration broadens AbbVie’s oncology research to access advanced precision medicine technology to expand the development of potentially life-changing treatments for patients with cancer.

Roche’s TECENTRIQ in combination with chemotherapy helped people with previously-untreated extensive-stage small cell lung cancer live significantly longer compared to chemotherapy

June 25, 2018

Roche has announced that the Phase III IMpower133 study met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) at its first interim analysis. The study demonstrated that initial (first-line) treatment with the combination of TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and etoposide) helped people with extensive-stage small cell lung cancer (ES-SCLC) live significantly longer compared to chemotherapy alone. The TECENTRIQ-based combination also reduced the risk of disease worsening or death (PFS) compared to chemotherapy alone. Safety for the TECENTRIQ and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination. These data will be presented at an upcoming medical meeting.

Pfizer Announces Overall Survival Results from Phase 3 Paloma-3 Trial of Ibrance® (Palbociclib) In Hr+, Her2- Metastatic Breast Cancer

June 25, 2018

Pfizer has announced overall survival (OS) results from the Phase 3 PALOMA-3 trial, which evaluated IBRANCE® (palbociclib) in combination with fulvestrant compared to placebo plus fulvestrant in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer whose disease has progressed after prior endocrine therapy. The results demonstrated a positive trend in the hazard ratio favoring the IBRANCE combination, although this trend did not reach statistical significance. Overall survival is a secondary endpoint of the PALOMA-3 trial and, as such, the trial design was not optimized to detect a statistically significant difference in OS.

IMBRUVICA® (ibrutinib) Supplemental New Drug Application Accepted for Review by U.S. FDA with Potential to Broaden Treatment Use as a Combination Treatment Option with Rituximab in Waldenström’s Macroglobulinemia (WM), A Rare Form of Blood Cancer

June 25, 2018

AbbVie, a research-based global biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental New Drug Application (sNDA) for IMBRUVICA® (ibrutinib) in combination with rituximab (RITUXAN®) as a new treatment option for Waldenström’s macroglobulinemia (WM), a rare and incurable form of blood cancer. If approved, the sNDA would expand the prescribing information of IMBRUVICA in WM beyond its current approved use as a single agent for all lines of therapy to include combination use with rituximab. As a single-agent therapy, IMBRUVICA is the first and only FDA-approved treatment available for patients with WM. IMBRUVICA is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.

 

Top Pharma News of the Week – June 25th last edit: 2018-06-27T19:39:48+00:00 da Luca

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