For a targeted treatment, developed by Seattle Genetics is in trial and the company is seeking for approval with conditions. FDA has asked monitoring committee for more clinical trial data that would back the conditional approval.
FDA on Tuesday issued documents to be considered by advisory committee in the wake of company's conclusion inferred from clinical trials. No major-safety concerns were raised in documents.
The under-trial drug is brentiximab vodotin with given Adcentris as brand name. Brentiximab is indicated to treat lymphom, a type of cancer which has not responded other available treatments. The drug is believed to be effective for treatment of Hodgkin and anaplastic lymphoma by increasing effects minimizing side effects of chemotherapy. It is co-developed with japan's pharmaceutical company.
The proposed cancer treatment drug is being reviewed by cancer drugs panel of FDA. Panel also includes some non-FDA medical personnel. FDA has asked the panel to vote on whether it can approve the drug or not.
Final decision is likely to come out in August. FDA is free to take or not to take advice from the panel.
Effect of positive notion from FDA can directly be seen on stock value of the company. Shares of Seattle Genetics have risen sixty two percent in a year.
Market experts took the released documents positive as no major concerns were there which may prevent the approval. However, company woun't be able to cash in on its product if the drug is approved for Hodgkin lymphoma only.
Estimated annual sales for the drug could be between $450-$500 million.
FDA on Tuesday issued documents to be considered by advisory committee in the wake of company's conclusion inferred from clinical trials. No major-safety concerns were raised in documents.
The under-trial drug is brentiximab vodotin with given Adcentris as brand name. Brentiximab is indicated to treat lymphom, a type of cancer which has not responded other available treatments. The drug is believed to be effective for treatment of Hodgkin and anaplastic lymphoma by increasing effects minimizing side effects of chemotherapy. It is co-developed with japan's pharmaceutical company.
The proposed cancer treatment drug is being reviewed by cancer drugs panel of FDA. Panel also includes some non-FDA medical personnel. FDA has asked the panel to vote on whether it can approve the drug or not.
Final decision is likely to come out in August. FDA is free to take or not to take advice from the panel.
Effect of positive notion from FDA can directly be seen on stock value of the company. Shares of Seattle Genetics have risen sixty two percent in a year.
Market experts took the released documents positive as no major concerns were there which may prevent the approval. However, company woun't be able to cash in on its product if the drug is approved for Hodgkin lymphoma only.
Estimated annual sales for the drug could be between $450-$500 million.
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