WASHINGTON (Reuters) - U.S. drug reviewers Might limit the use of a Seattle Genetics Inc experimental blood cancer drug due to the narrow scope of clinical trials icts, Sending the company's shares down 3.6 percent.
In documents released on Tuesday the Food and Drug Administration advisory panel year Asked to Consider the drug, Under the Proposed trade name Adcetris, for use in Previously Treated Patients with Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL). About a year are 9.000 Americans Diagnosed with Hodgkin's lymphoma and ALCL with 3.000.
The Suggested reviewers for the Labeling Should Hodgkin's patient focus group was smaller than expected, Limiting Potential dirty.According To the FDA documents, the Drug Should Be Considered for Patients Who HAD Already Been Given a stem cell transplant, Rather Than on all patients Treated as Suggested by the company.
The FDA advisory panel votes on the drug on Thursday.
Wall Street Analysts Noted the FDA reviewers raised HAD not unusual Any Concerns about the drug's safety or Effectiveness.
Cory Kasimov, a JPMorgan analyst, year 85 percent chance Sees The Drug Will Be Approved for Both diseases.
"That Said, We Still Believe That expansion in Earlier stages of disease with larger patient Markets is Critical to the stock's future valuation," He Said in a research note.
Howard Liang, an analyst at Leerink Swann, Sees U.S. sales at over $ 400 million for Both kinds of cancer in 2015.
Seattle Genetics shares closed down 74 cents at $ 19.80 on the Nasdaq.THEY hit all-time high year of $ 21.41 on June 28 After European Health Regulators Accepted year application to market the drug for Hodgkin's and ALCL Both in Europe.
"The stock is down Probably Because There Are Some hints allow the FDA May Not as Broad as a label the company IS seeking," Liang said.
LIMITED DATA FROM TRIALS
Preliminary trials in, Adcetris, Given in a 30-minute infusion Every Three weeks, complete response rates and Demonstrated Reduced tumor size in More than 90 percent of patients - 94 percent for Hodgkin's and 97 percent for ALCL, the company said.
The FDA Said Major side effects included nerve damage for Both, infections, reactions from the infusion and myelosuppression, a common side effect from chemotherapy That causes Decreased blood cell production military pilot school.
One patient aussi Dropped out of the study Hodgkin's Because Of Stevens Johnson Syndrome, a life-Threatening skin condition.
However, the mid-stage trials included only 58 patients for 102 patients for ALCL and Hodgkin's, and Did not compare to Adcetris Another drug. The FDA Said thesis factors "limit the Benefit-risk analysis."
The FDA reviewers Also Noted That no second trial Confirmed The Clinical Benefit of patients with ALCL in Adcetris, as required Under priority review, the advisory panel and Asked to weigh whether the drug accelerated Should Be Given Year Without Approval Such confirmation.
Seattle Genetics Chief Executive Clay Siegall Told Reuters in May Annual U.S. sales of That Adcetris for Hodgkin's and ALCL Would Likely Amount to less than $ 1 trillion.
Purpose if the drug wins Approval as a front-line therapy, or first option Treatment, The Annual U.S. Sales Could Be "is considerably over one billion dollars," Siegall said.
He added ET That Had a "high level of confidence" Would Adcetris U.S. winApproval by August 30 - the early decision date set by the FDA. [ID: nN25149337]
The FDA priority review status for Granted the drug, Known as brentuximab vedotin Chemically, the agency Meaning Believe The Medicine Is A Potentially significant advance over Existing therapies.
Brentuximab vedotin links a tumor-targeting antibody to a cancer-killing chemotherapy drug with the goal of Limiting side effects. It Is Designed to home in on year antigen, or foreign substance in Hodgkin's lymphoma, SEVERAL kinds of T-cell lymphoma and hematologic malignancies Other.
Seattle Holds the full U.S. and Canadian rights to Adcetris, while Japanese drugmaker Takeda Pharmaceutical Co Ltd Has the rights for the rest of the world, with milestone payments and royalties going to Seattle.
On June 27, Seattle Said It Would Receive a $ 5 million milestone payment That collaboration agreement Under the after the European Medicines Agency decision.
Seattle est aussi testing the drug in Other kinds of lymphoma.
(Editing by Michele Gershberg, Derek Caney and Andre Grenon)
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