ONO PHARMACEUTICAL : U.S. Food and Drug Administration Accepts Supplemental Biologics License Application for Opdivo (nivolumab) in Previously Treated Non-Squamous Non-Small Cell Lung Cancer Patients (164KB)

September 3, 2015

(PRINCETON, NJ, September 2, 2015) - Bristol-Myers Squibb Company (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the supplemental Biologics License Application (sBLA) for Opdivo for the treatment of previously treated patients with non-squamous (NSQ) non-small cell lung cancer (NSCLC). This sBLA seeks to expand the current indication for Opdivo in patients with previously treated squamous (SQ) NSCLC. The projected FDA action date is January 2, 2016.
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. 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: Renal Cell Carcinoma (RCC), 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. 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 and Glioblastoma.
Attached from the following page is the press release made by BMS for your information.
Contact
ONO PHARMACEUTICAL CO., LTD. Corporate Communications public_relations@ono.co.jp

U.S. Food and Drug Administration Accepts Supplemental Biologics License Application for

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Opdivo demonstratedanoveralslurvivablenefit.

About Lung Cancer

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About Opdivo

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 InTria1lt,herwe aasnincreasedincidencoeflevatedcreatininienthOe PDIVO-treatedgrouaps comparedtothcehemotherapy-treatedgroup(13%v9s%)G. rad2oe3irmmune-mediatednephritiosr renadlysfunctionoccurredin0.7%(2/268o)pfatientsI.nTria3lt,hiencidencoeflevatedcreatininwe as

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duringtreatmentA. dministehrormonreeplacementtherapyfohrypothyroidismI.nitiatme edical managemenftocrontroolhfyperthyroidism.

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 InTria3ls,eriouasdversreeactionosccurredin59%opfatientrseceivingOPDIVOT. hme osftrequent seriouasdversderugreactionrseportedin ≥2%opfatientws erdeyspneap,neumoniac,hroniocbstructive pulmonarydiseasexacerbationp,neumonitish,ypercal cemiap,leuraelffusionh,emoptysisa,ndpain.

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≥20%r)eportedwithOPDIVOinTria1wl erreash(21%a)ndin

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(32%)n,ause(a29%)a,ndconstipation(24%).

PleasseeUe .S. FulPlrescribingInformation foOr PDIVO.

Immuno-Oncology at Bristol-Myers Squibb

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About Bristol-Myers Squibb

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abouBt ristol-MyerSsquibbv,isit www.bms.como,frollowuosTn witteart http://twitter.com/bmsnews.

About the Bristol-Myers Squibb and Ono Pharmaceutical Collaboration

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Bristol-Myers Squibb Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private

Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and

involve inherent risks and uncertainties, including factors that could delay, divert or change any of them,

and could cause actual outcomes and results to differ materially from current expectations. No forward- looking statement can be guaranteed. Among other risks, there can be no guarantee that Opdivo will receive regulatory approval for the additional indication described in this release. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2014 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

###

Contacts:

Media:

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