bristol-myers squibb co (BMY) Key Developments
Kyowa Hakko Kirin and Bristol-Myers Squibb Announces Immuno-Oncology Clinical Collaboration Studying Mogamulizumab and Opdivo (nivolumab) in Advanced Solid Tumors in the U.S
Jul 30 15
Kyowa Hakko Kirin Co. Ltd. and Bristol-Myers Squibb Company have entered into a clinical trial collaboration agreement to conduct a Phase 1/2 combination study with mogamulizumab, an anti-CCR4 antibody and Opdivo  (nivolumab), a PD-1 immune checkpoint inhibitor. The study, which will be conducted in the U.S., will focus on evaluating the safety, tolerability and anti-tumor activity of combining mogamulizumab and Opdivo as a potential treatment option for patients with advanced or metastatic solid tumors. Prior to this agreement, Kyowa Hakko Kirin, Bristol-Myers Squibband Ono Pharmaceutical Co. Ltd. entered into a clinical trial collaboration agreement to study the combination of mogamulizumab and Opdivo in Japan. Mogamulizumab and Opdivo are part of a new class of cancer treatments known as immunotherapies, which are designed to harness the body’s own immune system in fighting cancer by targeting distinct regulatory components of the immune system. The study will be conducted by Kyowa Hakko Kirin. About Mogamulizumab.
Bristol-Myers Squibb Company Announces Discontinuation of Phase III Renal Cell Carcinoma Study
Jul 29 15
Bristol-Myers Squibb Company has announced the discontinuation of an open-label, randomized Phase III study evaluating Opdivo versus everolimus in previously-treated patients with advanced or metastatic renal cell carcinoma, or RCC, based on an assessment conducted by the independent Data Monitoring Committee, or DMC, concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm. CheckMate -025 investigators are being informed of the decision to stop the comparative portion of the trial. Bristol-Myers Squibb is working to ensure that eligible patients will be informed of the opportunity to continue or start treatment with Opdivo in an open-label extension as part of the company's commitment to providing patient access to Opdivo, and characterizing long-term survival. CheckMate -025 is a Phase III, open-label, randomized study of Opdivo versus everolimus in previously-treated patients with advanced or metastatic clear-cell renal cell carcinoma. The trial randomized 821 patients to receive either nivolumab 3 mg/kg intravenously every two weeks or everolimus 10 mg tablets by mouth daily until documented disease progression or unacceptable toxicity. The primary endpoint is overall survival. Secondary endpoints include objective response rate and progression-free survival.
Bristol-Myers Squibb Extends Compassionate Use Agreement for Opdivo with Italian Medicines Agency
Jul 29 15
The Italian Medicines Agency (AIFA) reported on 27 July 2015 that it had reached an agreement with Bristol-Myers Squibb (BMS) to extend a compassionate use agreement for the immuno-oncology drug Opdivo (nivolumab). Compassionate use agreements allow for the use of an unauthorised medicine for patients with a disease or condition for which there is no satisfactory authorised therapy. The agreement is intended to facilitate a medicine's availability while the treatment undergoes regulatory approval. BMS recently received a second approval from the European Commission for the use of Opdivo as a treatment option in patients with locally advanced or metastatic squamous (MS) non-small-cell lung cancer (NSCLC) following prior chemotherapy treatment. At the request of AIFA, Italy's Oncology Medical Association, and the Italian Association of Oncology Doctors, BMS launched the compassionate use programme for Opdivo on 21 April. Under the terms of the new agreement, the compassionate use programme will be extended until 18 September for all new patients diagnosed with NSCLC. This will ensure the continuation of current treatments that patients are on until the market authorisation comes into force in Italy.
Bristol-Myers Squibb Plans to Expand its Manufacturing Facility in Humacao, Puerto Rico
Jul 28 15
Bristol-Myers Squibb has announced investments of USD 165 million to expand its manufacturing facility in Humacao, Puerto Rico. The company's expansion plans will facilitate the
production of type 2 diabetes medicines.
FDA Approves Bristol-Myers Squibb Company's Daklinza (daclatasvir) for the Treatment of Patients with Chronic Hepatitis C Genotype 3
Jul 24 15
Bristol-Myers Squibb Company announced that Daklinza™ (daclatasvir), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA). This approval marks the first time patients with chronic hepatitis C virus (HCV) genotype 3 have a 12-week, once-daily, all-oral treatment option. Daklinza is indicated for use with sofosbuvir for the treatment of patients with chronic HCV genotype 3 infection. Sustained virologic response (SVR) rates are reduced in HCV genotype 3-infected patients with cirrhosis receiving this regimen. The recommended dosage of Daklinza is 60 mg in combination with sofosbuvir for 12 weeks. The pivotal Phase III open-label ALLY-3 clinical trial enrolled 152 patients with chronic HCV genotype 3 infection and compensated liver disease (101 treatment-naïve patients and 51 treatment-experienced patients). The co-primary endpoints were sustained virologic response rates 12 weeks after completing therapy (SVR12) in each treatment group. The full study design is outlined below. In the trial the Daklinza plus sofosbuvir regimen demonstrated SVR12 in 90% of treatment-naïve and 86% of treatment-experienced chronic HCV genotype 3 patients. SVR12 rates were higher (96%) in genotype 3 patients without cirrhosis, regardless of treatment history. In the more difficult-to-treat patients with cirrhosis, SVR12 rates were reduced (63%). These SVR12 rates were achieved with 12 weeks of therapy without the use of ribavirin. In the pivotal Phase III trial, there were no treatment-related serious adverse events (SAEs) and no discontinuations due to adverse events (AEs). The most common treatment-related AEs at a frequency of =5% were headache (14%), fatigue (14%), nausea (8%) and diarrhea (5%).