|FDA approves Onyx's Drug Kyprolis; Seattle Genetics Announces Positive CHMP Opinion for ADCETRIS|
|By Staff and Wire Reports|
|Friday, 20 July 2012 18:38|
The U.S. FDA said it approved a new blood cancer drug from Onyx Pharmaceuticals Inc. (NASDAQ:ONXX) for patients with advanced disease who have not responded to at least two other drugs.
The injectable drug Kyprolis treats multiple myeloma, a form of cancer that causes tumors to grow in the bone marrow, preventing the production of normal blood cells. Patients with the disease have low red blood cell counts and are more likely to experience infections and excessive bleeding.
The FDA approved the drug for patients who have already tried at least two other drugs, including Velcade and various drugs that boost the immune system.
Shares of South San Francisco, Calif.-based Onyx Pharmaceuticals rose $6.34, or 9.3 percent, to $74.74.
The company studied the drug in 266 patients with advanced multiple myeloma who had already been treated with Velcade and thalidomide. About 23 percent of patients experienced a full or partial disappearance of their tumors, with the typical effect lasting about 7.8 months.
Thirty percent of patients experienced side effects from the drug, including fatigue, fever, shortness of breath and diarrhea.
About 21,700 people will be diagnosed with multiple myeloma this year and 10,710 will die from the disease, according to the American Cancer Society.
The drug was approved under the FDA's accelerated approval program, which allows the agency to clear drugs based on promising preliminary data. Drug companies have to submit follow-up studies showing that the drug performed as expected.
Seattle Genetics, Inc. (Nasdaq: SGEN) announced its collaborator, Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the conditional marketing authorization of ADCETRIS (brentuximab vedotin) for two indications: (1) the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30.
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that their July 12th RetailInvestorConferences.com presentation is now available for on-demand viewing.
Exactech, Inc. (NASDAQ: EXAC), a developer and producer of bone and joint restoration products for total joint replacement, and CONMED Corporation (NASDAQ: CNMD), a global leader in the development and manufacturing of surgical instruments and devices, announced today their plans to co-develop a series of medical education programs designed to advance the standard of care for patients across the continuum of shoulder and knee repair.
La Jolla Pharmaceutical Company (OTCQB: LJPC) today announced that their July 12th RetailInvestorConferences.com presentation is now available for on-demand viewing.
Positron Corporation (OTCBB:POSC), a molecular imaging healthcare company, announces approval of a Pledge Resolution for $15 Million in Tax Increment Financing (TIF) Bonds,from the Redevelopment Commission of the City of Gary, Indiana towards the development of Positron's 70 MeV cyclotron project.
Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced today that several trials within ODYSSEY, the Phase 3 clinical program of SAR236553/REGN727, have initiated patient enrollment. SAR236553/REGN727 is a potential first-in-class, subcutaneously administered, fully-human antibody that lowers low-density lipoprotein (LDL) cholesterol by targeting PCSK9 (proprotein convertase subtilisin/kexin type 9), an enzyme which binds LDL receptors, leading to their accelerated degradation and increased LDL-cholesterol (LDL-C) levels.