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FDA Approvals

In 2012, California companies were responsible for nine of the FDA’s 39 approved new molecular entities (NME), or about 23 percent. A NCE or NME is a drug that is without precedent among regulated and approved drug products and is an indication of innovation in the development of new drugs and therapeutic biological products. In total, 63 products were approved, 208 were marketed and 28 were in registration. The following snapshot features Medivation, which received FDA approval this year for XTANDI® (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer who have received docetaxel. XTANDI® is marketed in the U.S.

Company Product Approved Description Disease Area Indication
Affymax Inc. Omontys 3/27/12 Erythropoietin (EPO) receptor agonist Hematology Anemia
Arena Pharmaceuticals Belviq 6/27/12 Serotonin (5-HT2C) receptor agonist Endocrine / Metabolic Obesity
Genentech Inc. Erivedge 1/30/12 Smoothened antagonist Cancer Basal cell carcinoma (BCC)
Genentech Inc. Perjeta 6/8/12 Antibody to (EGFR2) (HER2) (ErbB2) (neu) Cancer Breast cancer
Gilead Sciences Stribild 8/27/12 HIV integrase inhibitor; HIV reverse transcriptase inhibitor; Cytochrome P450 3A (CYP3A) inhibitor Infectious HIV / AIDS
Medivation Inc. Xtandi 8/31/12 Androgen receptor antagonist Cancer Prostate cancer
Onyx Pharmaceuticals Kyprolis 7/20/12 Proteasome inhibitor Cancer Multiple myeloma (MM)
Vivus Inc. Qsymia 4/27/12 Low-dose combination of phentermine and topiramate Obesity Obesity
Exelixis, Inc COMETRIQ 11/29/12 CABOZANTINIB Cancer Thyroid Cancer



“Innovation is important to the life sciences industry because human diseases are complex, generally multifactorial in origin and constantly changing and adapting to and resisting therapeutic approaches to combat them.”

David Hung, M.D.
Co-Founder and CEO, Medivation

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City of Hope

City of Hope
“The center’s work in recombinant DNA technology, gene therapy and monoclonal antibodies have advanced their fields, leading to breakthroughs affecting people worldwide. Here, scientific discoveries can, and do, become real-world care.”

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