ONO PHARMACEUTICAL CO., LTD. (PRINCETON, NJ, November 24, 2015) - Bristol-Myers Squibb Company (NYSE:BMY) announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection, for intravenous use, as a single agent for the treatment of patients with BRAF V600 wild-type (WT) unresectable or metastatic melanoma. The approval is based on data from the Phase 3 trial, CheckMate - 066, which evaluated overall survival as the primary endpoint in treatment-naïve patients with BRAF WT unresectable or metastatic melanoma compared to chemotherapy (dacarbazine).
In USA, Opdivo was approved under accelerated approval for the treatment of unresectable or metastatic melanoma and disease progression following Yervoy and, if BRAF V600 mutation positive, a BRAF inhibitor in December 2014 and approved for the treatment of metastatic squamous NSCLC with progression on or after platinum-based chemotherapy in March 2015. Opdivo in combination with Yervoy for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma received the approval in October 2015. Also, Opdivo received expanded FDA approval in previously- treated metastatic non-small cell lung cancer in the same month. Furthermore, Opdivo was approved for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy in November 2015. In EU, Opdivo was approved for the treatment of advanced (unresectable or metastatic) melanoma in adults regardless of BRAF status in June 2015. European Commission approved Nivolumab BMS for the treatment of locally advanced or metastatic squamous NSCLC after prior chemotherapy in July 2015.
Also, BMS has a robust clinical development program in a variety of tumor types overseas, including: Head and Neck Cancer, Blood Cancer, Glioblastoma, Colorectal Cancer, Pancreatic Cancer, Gastric Cancer, Hepatocellular Carcinoma, Triple-Negative Breast Cancer, Small-Cell Lung Cancer, Urothelial Cancer, etc. In Japan, ONO launched it for the treatment of unresectable melanoma in September 2014. Also, ONO is conducting clinical development programs including RCC, NSCLC, Head and Neck Cancer, Gastric Cancer, Esophageal Cancer, Hepatocellular Carcinoma, Hodgkin Lymphoma, Urothelial Cancer, Glioblastoma, Ovarian Cancer, etc.
Attached from the following page is the press release made by BMS for your information.
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Bristol-Myers Squibb Announces U.S. Food and Drug Administration Approval for Opdivo (nivolumab) as a Single Agent for the Treatment of Patients with Previously Untreated BRAF Wild-Type Advanced Melanoma
First and only PD-1 immune checkpoint inhibitor approved as a single agent for first-line use in advanced BRAF wild-type melanoma
Approval based on Phase 3 trial, CheckMate -066, which demonstrated superior overall survival vs. dacarbazine in first-line treatment of patients with BRAF wild-type advanced melanoma
Marks the sixth FDA approval for Opdivo in the past 12 months
(PRINCETON, NJ, November 24, 2015) - Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection, for intravenous use, as a single agent for the treatment of patients with BRAF V600 wild-type (WT) unresectable or metastatic melanoma. The approval is based on data from the Phase 3 trial, CheckMate -066, which evaluated overall survival as the primary endpoint in treatment-naïve patients with BRAF WT unresectable or metastatic melanoma compared to chemotherapy (dacarbazine).
'Our focused approach to Immuno-Oncology research is to deliver treatment options that have the potential to improve long-term survival outcomes for patients,' said Michael Giordano, M.D., senior vice president, head of Oncology Development, Bristol-Myers Squibb. 'Opdivo has become a critical part of the treatment landscape for advanced melanoma patients and their physicians, both as a monotherapy and in combination, and we are committed to exploring opportunities for this treatment across stages of disease and lines of therapy.'
Opdivo is associated with immune-mediated: pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, rash, encephalitis, other adverse reactions; infusion reactions; and embryofetal toxicity. Please see additional Important Safety Information section below.
'Advanced melanoma continues to be one of the deadliest and most challenging cancers to treat, and ongoing research in Immuno-Oncology from clinical trials like CheckMate -066 shows the potential to provide improved overall survival for newly diagnosed patients with BRAF wild-type metastatic melanoma,' said Jeffrey S. Weber, M.D., PhD, deputy director of the Laura and Isaac Perlmutter Cancer Center at the NYU Langone Medical Center. 'This important news means that we now have another new option to offer patients with BRAF wild-type metastatic melanoma.'
A supplemental Biologics License Application for Opdivo in BRAF V600 mutation positive unresectable or metastatic melanoma, which was filed subsequent to data from CheckMate -066, is still under review with the FDA.
Opdivo Demonstrated Efficacy in Newly Diagnosed BRAF Wild-Type Advanced Melanoma
CheckMate -066 is a Phase 3, randomized, double-blind study of treatment-naïve patients with unresectable or metastatic BRAF WT melanoma. Patients were randomized to receive Opdivo (intravenously 3 mg/kg q2w; n=210) or dacarbazine (intravenously 1000 mg/m2 q3w; n=208). The primary efficacy endpoint of the trial was overall survival (OS), and secondary endpoints were progression-free survival (PFS) and objective response rate (ORR).
In the trial, Opdivo demonstrated superior OS versus chemotherapy in the first-line setting.
Results were based on the interim analysis conducted on 47% of the total planned events for OS (50 for the Opdivo arm; 96 for the dacarbazine arm). The median OS was not reached for Opdivo and was 10.8 months (95% CI: 9.3-12.1) in the dacarbazine arm (HR=0.42; 95% CI: 0.30-0.60; pOpdivo (5.1 months [95% CI: 3.5-10.8] vs. 2.2 months [95% CI: 2.1-2.4] for patients treated with dacarbazine [HR=0.43; 95% CI: 0.34-0.56; pOpdivo was 34% (4% complete response rate, 30% partial response rate [95% CI: 28-41]) compared to 9% with dacarbazine (1% complete response rate, 8% partial response rate [95% CI: 5-13]). At the time of analysis, 88% (63/72) of Opdivo-treated patients had ongoing responses, which included 43 patients with ongoing responses of six months or longer.
Last year, the CheckMate -066 trial was stopped early following a recommendation by the independent Data Monitoring Committee based on their analysis which showed evidence of superior OS in patients receiving Opdivo compared to the control arm. As a result, patients in the trial were unblinded and patients who had received dacarbazine were allowed to receive Opdivo. Dacarbazine was selected as the comparator in this study because, at the time the study protocol was designed, it represented the standard of care in many regions outside of the U.S where Yervoy had not yet been approved for first-line use.
In the trial, serious adverse reactions occurred in 36% of patients receiving Opdivo. Grade 3 and 4 adverse reactions occurred in 41% of patients receiving Opdivo. The most frequent Grade 3 and 4 adverse reactions reported in >2% of patients receiving Opdivo were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). Adverse reactions led to permanent discontinuation of Opdivo in 7% of patients and dose interruption in 26% of patients. The most common adverse reactions in
CheckMate -066 (>20%) reported with Opdivo versus dacarbazine were fatigue (49% vs. 39%),
musculoskeletal pain (32% vs. 25%), rash (28% vs. 12%), and pruritus (23% vs. 12%).
Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment- producing cells (melanocytes) located in the skin. Metastatic melanoma is the deadliest form of the disease, and occurs when cancer spreads beyond the surface of the skin to the other organs, such as the lymph nodes, lungs, brain or other areas of the body. The incidence of melanoma has been increasing for at least 30 years. In the U.S., more than 73,000 cases of melanoma will be diagnosed this year and nearly 10,000 people are expected to die from the disease. Melanoma is mostly curable when treated in its early stages. However, in its late stages, the average survival rate has historically been just six months with a one-year survival rate of 25.5%, making it one of the most aggressive forms of cancer.
Bristol-Myers Squibb is a pioneer in the field of cancer research and treatment known as Immuno-Oncology, which involves agents whose primary mechanism is to work directly with the body's immune system to fight cancer.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor, and works by targeting the immune system through the PD-1 immune checkpoint pathway.
Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 50 trials - as a monotherapy or in combination with other therapies
- in which more than 8,000 patients have been enrolled worldwide.
Bristol-Myers Squibb remains committed to helping patients through treatment with Opdivo. For support and assistance, patients and physicians may call 1-855-OPDIVO-1. This number offers one-stop access to a range of support services for patients and healthcare professionals alike.
Bristol-Myers Squibb is committed to helping patients access Opdivo and offers BMS Access Support® to support patients and providers in gaining access. BMS Access Support®, the Bristol-Myers Squibb Reimbursement Services program, is designed to support access to BMS medicines and expedite
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