AbbVie and Bristol-Myers Squibb Collaborate to Evaluate the Combination of Rova-T plus Opdivo and Opdivo + Yervoy Regimen

abbvie-bristol

July 25, 2016

AbbVie and Bristol-Myers Squibb Company have announced a clinical trial collaboration for evaluating the safety, efficacy, and tolerability of investigational biomarker-specific antibody drug conjugate Rova-T (rovalpituuzumab tesirine) of AbbVie in combination with Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen of Bristol-Myers Squibb as a treatment for relapsed extensive-stage small cell lung cancer (SCLC).

 

Bristol-Myers Squibb Collaborates with Janssen in Immuno-Oncology Research Focused on Lung Cancer

Bristol-Myers

July 26, 2016

Bristol-Myers Squibb Company has announced a new clinical research collaboration with Janssen Biotech, Inc. to evaluate Bristol-Myers Squibb’s Immuno-Oncology (I-O) agent Opdivo (nivolumab) and Janssen’s Live Attenuated Double–Deleted (LADD) Listerial monocytogenes cancer immunotherapy, expressing mesothelin and EGFRvIII (JNJ-64041757), in patients with non-small cell lung cancer (NSCLC).

Takeda and Seattle Genetics Announce Positive Data from Phase 3 ALCANZA Clinical Trial of ADCETRIS® (Brentuximab Vedotin) for CD30-Expressing Cutaneous T-Cell Lymphoma

takeda-seattle

August 1, 2016

Takeda Pharmaceutical Company Limited and Seattle Genetics, Inc. have announced that the Phase 3 ALCANZA clinical trial assessing ADCETRIS (brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL) met its primary endpoint. It showed a highly statistically significant improvement in the rate of objective response lasting at least four months (ORR4).

 

Amgen and Advaxis Enter Global Cancer Immunotherapies Collaboration

amgen-advaxis

August 2, 2016

Amgen and Advaxis, Inc. have announced a global agreement for the development and commercialization of Advaxis’ ADXS-NEO. It is a novel, preclinical investigational cancer immunotherapy treatment that is designed to activate the immune system of a patient to respond against the unique mutations, or neoepitopes, contained in and identified from the tumor of each individual patient. This collaboration brings together the development expertise of Amgen in immuno-oncology with the MINE™ (My Immunotherapy Neo-Epitopes) program of Advaxis, which is uniquely positioned for developing a customized approach to treat cancer.

Takeda Gets Marketing Authorization for NINLARO™ (ixazomib) in Relapsed/Refractory Multiple Myeloma in Canada

2000px-logo_takeda-svg

August 8, 2016

Takeda Pharmaceutical Company Limited has announced Takeda Canada has received approval from Health Canada for NINLARO™ (ixazomib) capsules in combination with lenalidomide and dexamethasone for treating adult patients with multiple myeloma who have received at least one prior therapy. It is estimated that approximately 7,500 people live with multiple myeloma in Canada. The approval was mainly based on the results of the final analysis of the pivotal Phase 3 trial, TOURMALINE-MM1. It demonstrated that NINLARO in combination with lenalidomide and dexamethasone extended progression-free survival significantly, with a manageable safety profile in patients with relapsed/refractory multiple myeloma.

FDA Approves KEYTRUDA® (pembrolizumab) of Merck for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Merck Igea Luca Dezzani

August 8, 2016

Merck has announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA®(pembrolizumab). It is the company’s anti-PD-1 (programmed death receptor-1) therapy, at a fixed dose of 200 mg every three weeks, for treating patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. This indication for KEYTRUDA is approved under the FDA’s accelerated approval regulations, based on tumor response rate and durability of response.

Boehringer Ingelheim Gives Global Development and Commercial Rights to Amgen for Investigational BiTE® Immuno-Oncology Drug for Multiple Myeloma

boehringer-amgen

September 1, 2016

Boehringer Ingelheim and Amgen have announced that Amgen has acquired global development and commercial rights from Boehringer Ingelheim for BI 836909 (AMG 420), a bispecific T cell engager (BiTE®) that targets B-cell maturation antigen (BCMA), a potential target for multiple myeloma. BI 836909 (AMG 420) is currently in Phase 1 studies. Boehringer Ingelheim got the original license of BI 836909 (AMG 420) from Micromet before the company was acquired by Amgen in 2012.

BLINCYTO® (blinatumomab) is Approved by FDA for Use in Pediatric Patients with Philadelphia Chromosome-Negative Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia

Amgen Igea Luca Dezzani

September 1, 2016

Amgen has announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) supporting the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval, and continued approval may depend upon verification of clinical benefits in subsequent trials.

FDA Accepts Supplemental Biologics License Application for Merck’s KEYTRUDA® (pembrolizumab) for First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer

Merck Igea Luca Dezzani

September 7, 2016

Merck has announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) for Priority Review.  KEYTRUDA® is Merck’s anti-PD-1 therapy that is used as the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC). In addition, the FDA granted Breakthrough Therapy Designation for this indication. Merck has also submitted a Marketing Authorization Application to the European Medicines Agency for KEYTRUDA®.

Pfizer Gets Positive CHMP Opinion for IBRANCE® (palbociclib) in Combination with Endocrine Therapy for The Treatment of HR+/HER2- Metastatic Breast Cancer in Europe

Pfizer Igea Luca Dezzani

September 16, 2016

Pfizer Inc. has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that IBRANCE® (palbociclib) be granted marketing authorization in the European Union (EU) for treating women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer. This positive opinion from CHMP is for IBRANCE to be used in combination with fulvestrant in women who have received prior endocrine therapy, as well as in combination with an aromatase inhibitor. European Commission (EC) will now review The CHMP’s opinion.

Amgen Announces Top-Line Results from Phase 3 KYPROLIS® (Carfilzomib) CLARION Study in Patients with Newly Diagnosed Multiple Myeloma

Amgen Igea Luca Dezzani

September 27, 2016

Amgen has announced top-line results of the Phase 3 CLARION trial evaluating an investigational regimen of KYPROLIS® (carfilzomib), melphalan and prednisone (KMP) versus Velcade® (bortezomib), melphalan and prednisone (VMP) for 54 weeks in patients with newly diagnosed multiple myeloma who were not eligible for hematopoietic stem-cell transplant. The trial did not meet the primary endpoint of superiority in progression-free survival (PFS). The observed hazard ratio (KMP versus VMP) was 1.21 (95 percent CI, 0.90 – 1.64) while the data for overall survival, a secondary endpoint, are not yet mature. Neither result was statistically significant. These data will be submitted to a future medical conference and for publication.

Treatment outcome data from The Prostate Cancer Registry presented for the first time at the 2016 ESMO Congress

janssen-logo

October 10, 2016

Janssen-Cilag International NV has presented the first reported primary treatment outcome data from The Prostate Cancer Registry at the 2016 European Society for Medical Oncology (ESMO) Congress in Copenhagen, Denmark. The Prostate Cancer Registry is the first and largest prospective study of men with metastatic castration-resistant prostate cancer (mCRPC) in Europe. The preliminary data suggest that chemotherapy-naïve patients benefit more from treatment than post-chemotherapy patients. Furthermore, patients have a higher prostate-specific antigen (PSA) response when treated with androgen receptor-targeted agents than with taxanes, after first line docetaxel treatment.

Amgen Announces Positive Top-Line Results From XGEVA® (Denosumab) Phase 3 Trial for Patients with Multiple Myeloma

Amgen Igea Luca Dezzani

October 20, 2016

Amgen has announced that a Phase 3 study evaluating XGEVA® (denosumab) versus zoledronic acid met the primary endpoint of non-inferiority (hazard ratio = 0.98, 95 percent CI, 0.85 – 1.14) in delaying the time to first on-study skeletal-related event (SRE) in patients with multiple myeloma. The secondary endpoints of superiority in delaying time to first SRE and delaying time to first-and-subsequent SRE were not met. XGEVA’s hazard ratio versus zoledronic acid for overall survival was 0.90 (95 percent CI, 0.70 – 1.16).

Lynparza Phase III SOLO-2 trial reveals substantial progression-free survival benefit

astrazeneca

26 October 2016

AstraZeneca has announced positive results from the Phase III SOLO-2 trial for determining the effectiveness of Lynparza (olaparib) tablets (300mg twice daily) as a monotherapy for the maintenance treatment of platinum-sensitive relapsed, BRCA-mutated ovarian cancer. The results demonstrate a statistically-significant and clinically-meaningful improvement of progression-free survival (PFS) among patients treated with Lynparza compared to placebo. This may be considered as additional evidence for supporting the potential use of Lynparza in this patient population.

EMA Validates the Marketing Authorization Application for Avelumab for Treating Metastatic Merkel Cell Carcinoma

Pfizer Merck Igea Luca dezzani

October 31, 2016

Merck KGaA, Darmstadt, Germany, and Pfizer Inc. have announced that the European Medicines Agency (EMA) has validated Marketing Authorization Application (MAA) for avelumab for the proposed indication of metastatic Merkel cell carcinoma (MCC). It is an aggressive and rare skin cancer, which impacts approximately 2,500 Europeans a year. If approved, avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, could be the first approved treatment in the EU indicated for metastatic MCC. Metastatic MCC patients face a very poor prognosis, with less than 20 percent surviving beyond five years.

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