| Spectrum Pharma Receives CRL from FDA for Zevalin sBLA | | Print | |
| Sunday, 05 July 2009 09:52 | ||||||||||||||||||||||||
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The FDA requested the Company to submit data files from the FIT study to support and verify a subset of the data that are currently under review to support the proposed labeling. Importantly: 1) No additional clinical studies have been requested; 2) The additional data requested do not involve new data analyses; 3) The Company plans to formally respond to the FDA’s requests by this Wednesday, July 8, 2009. Spectrum is confident that the data it will submit will satisfy the requirements of the Complete Response letter, and, at this time, continues to expect a favorable regulatory decision. FDA Requests Data From The FIT Study To Validate Subset Of sBLA Package Spectrum Will Provide All Data Requested By The FDA As Part Of Its Formal Response By Wednesday, July 8th At The Latest FDA Request Does Not Involve New Clinical Studies or New Data Analyses ZEVALIN Is Currently FDA Approved and Marketed by Spectrum for Patients With Relapsed or Refractory, Low-Grade or Follicular B-Cell Non-Hodgkin’s Lymphoma, Including Patients Who Have Rituximab-Refractory Follicular NHL BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read at the bottom of / About Us / Section Add this page to your favorite Social Bookmarking websites           
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Comments (7)
Mike Havrilla
said:
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IRVINE, Calif.-- Spectrum Pharmaceuticals (Nasdaq:SPPI), a commercial-stage biotechnology company with a focus in oncology, today announced that it has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its supplemental Biologics License Application (sBLA) for ZEVALIN® (ibritumomab tiuxetan) in the first-line consolidation setting for non-Hodgkin’s Lymphoma (NHL) patients.
The Prescription Drug User Fee Act (PDUFA) Action Date for the ZEVALIN sBLA in the first-line consolidation setting was July 2, 2009. ZEVALIN is currently FDA approved and marketed by Spectrum for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients who have rituximab-refractory follicular NHL.
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... CRL Resubmissions are classified as either Class 1 (60-day) or Class 2 (6-month) Reviews by the FDA once they are officially accepted by the Agency. Based on the PR today by SPPI, seems very likely to be a 60-day Class 1 review for the Zevalin sBLA since the Company only needs to submit additional data and plans to do so within the next few days. Once data is submitted and accepted by FDA, the Agency will provide a more definitive timeline for the Zevalin sBLA. |
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sliderulex
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... One has to wonder why SPPI didn't foresee the NEED to submit all data to the FDA? Either the FDA is way behind schedule and is using this as an excuse to allow them the time to get to Zevalin, or SPPI really did screw this up. But I think the former is more likely. |
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Mike
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... Mike, does this mean that if it is a 60 day Class1 that it will be 60 days more until decision from FDA or can that be anytime within the 60 days? Like next week or even later this week? |
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Mike Havrilla
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... The FDA could respond before 60 days of Spectrum's resubmission and the Agency may give some comment over the timeline for review once they officially accept Specrum's resubmission. |
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Chuck
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... This is just a minor setback. The FDA has been working earnestly(from it seems) to make sure safe and effective drugs are on the market.If you are a long term holder, and believe Spectrum's drug pipeline is promising(I'm assuming you have done your DD),then this a great opportunity to purchase shares at a lower price. Will the FDA approve Zevalin? Who knows. In the words of John Templeton:"The time of maximum pessimism is the best time to buy, and the time of maximum optimism is the best time to sell." |
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Mike Havrilla
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... FDA will likely formally accept Spectrum's resubmission within 1-2 weeks and rule as a Class 1 Review. The 60-day review deadline is calculated from the resubmission date (e.g. no later than Weds. 7/8 according to SPPI). |
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