About Us

Historical Timeline

Milestones

2014

Pfizer reports positive topline results of its Phase 3 trial of Palbociclib in advanced breast cancer. Palbociclib is a Pfizer compound being developed by Pfizer. If approved, Onyx will receive an 8% royalty on global net sales.

2013

NEXAVAR® (sorafenib) receives third FDA indication. See www.nexavar-us.com for more information.

Onyx is acquired by Amgen and becomes an Amgen Subsidiary.

Bayer and Onyx report positive data from Phase 3 DECISION trial of Nexavar for Patients with Radioactive Iodine-Refractory Differentiated Thyroid Cancer; submit U.S. FDA and EMA regulatory applications.

Palbociclib receives FDA Breakthrough therapy designation; Pfizer initiates Phase 3 trial of Palbociclib in advanced breast cancer. Palbociclib is a Pfizer compound being developed by Pfizer. If approved, Onyx will receive an 8% royalty on global net sales.

Onyx and University of California, San Francisco (UCSF) form Oncology Innovation Alliance, a public-private partnership focusing on the discovery and development of novel cancer therapies.

2012

Pfizer announces positive Phase 2 data for Palbociclib for the treatment of metastatic breast cancer at San Antonio Breast Cancer Symposium.

Onyx receives FDA accelerated approval of Kyprolis® (carfilzomib) for Injection and launches comprehensive patient support program, Onyx Pharmaceuticals 360™ (Onyx 360).

Onyx initiates Carfilzomib ENDEAVOR study, a head-to-head comparison trial vs. Velcade in patients with relapsed multiple myeloma.

Carfilzomib receives positive vote from Oncologic Drugs Advisory Committee (ODAC).

Onyx and University of Texas MD Anderson Cancer Center announce strategic alliance in multiple myeloma and lymphoma.

2011

Onyx and Multiple Myeloma Research Foundation announce multi-year collaboration to accelerate personalized medicine approaches for multiple myeloma.

FDA accepts the Kyprolis® (proposed tradename for carfilzomib) New Drug Application for review under the accelerated approval pathway for potential treatment of patients with relapsed and refractory multiple myeloma.

Onyx and Multiple Myeloma Research Foundation launch Carfilzomib Myeloma Access Program (C-MAP), an expanded access program that makes Carfilzomib available to eligible patients in the United States with relapsed and refractory multiple myeloma.

U.S. FDA grants Carfilzomib Fast Track Designation for the potential treatment of patients with relapsed and refractory multiple myeloma; Onyx initiates rolling New Drug Application submission for accelerated approval.

2010

Onyx reports positive complete results from Phase 2b study of single-agent Carfilzomib in patients with relapsed and refractory multiple myeloma.

Onyx enters into an exclusive agreement valued in excess of $300 million with Ono Pharmaceutical, giving Ono the rights to develop and commercialize Carfilzomib and Oprozomib for all oncology indications in Japan.

Phase 3 ASPIRE trial begins, evaluating Carfilzomib in combination with lenalidomide (Revlimid) and low-dose dexamethasone in patients with relapsed multiple myeloma.

Oprozomib, an oral proteasome inhibitor, enters clinical testing.

2009

Onyx acquires Proteolix Inc., a privately held biopharmaceutical company focused on discovering and developing novel therapies that target the proteasome for the treatment of patients with cancer and autoimmune diseases.

Phase 3 DECISION trial begins, evaluating Sorafenib in patients with radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer.

Onyx and Bayer report positive results from a Phase 2 trial evaluating Sorafenib plus the chemotherapeutic agent, capecitabine, in patients with advanced breast cancer.

2008

Hollings Renton retires as chairman and CEO of Onyx.

N. Anthony Coles, M.D., joins Onyx as president and CEO.

Nexavar® (sorafenib) Tablets pivotal liver cancer study (SHARP) published in The New England Journal of Medicine.

2007

NEXAVAR pivotal kidney cancer study (TARGET) published in The New England Journal of Medicine.

NEXAVAR receives second FDA Indication.  See www.nexavar.com for more information.

2005

NEXAVAR receives first FDA Indication.  See www.nexavar.com for more information.

2004

PD 0332991, an oral, cell cycle inhibitor, enters clinical testing.

2003

Onyx focuses its efforts solely on the development of sorafenib and discontinues therapeutic virus program.

2000

Sorafenib, an oral systemic therapy, enters clinical testing.

1998

Onyx and Warner Lambert, now Pfizer, extend collaboration in area of cell cycle regulation.

1996

Frank McCormick leaves Onyx to become head of the University of California, San Francisco Cancer Center and Cancer Research Institute.

Onyx completes IPO and is listed on the Nasdaq under stock symbol ONXX.

1995

Onyx and Warner Lambert, now Pfizer, form collaboration to develop therapeutics for cell cycle regulation.

1994

Onyx and Miles Inc. (predecessor to Bayer HealthCare Pharmaceuticals, Inc.) form collaboration.

1993

Onyx appoints Hollings Renton as the company’s first president and CEO.

1992

Onyx Pharmaceuticals is founded by Frank McCormick to discover and develop cancer therapeutics and is spun out of the Cetus and Chiron merger as privately held company.

1991

Cetus Corporation merges with Chiron Corporation.

1985

Frank McCormick, Ph.D., begins cancer research program at Cetus Corporation.