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Spectrum Pharmaceuticals, Inc. Message Board

  • imho_dyodd imho_dyodd Nov 28, 2012 8:41 AM Flag

    Zevalin administration licensing requirements and it's impact to sales

    Guys, people who have done dd on this subject, pls post your thoughts on this.

    If this requirement is removed, can Zevalin reach $150m/year in USA

    Also, post your thoughts on what it would take to remove this requirement ? lobbying.

    weird, ceo made some big statements that they think this was a major stumbling block to zevalin adoption in Aug/sep, but this did not even get a mention in November investor pres.

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    • google In a randomized Phase III clinical trial for patients withrelapsed and refractory indolent lymphoma, comparing Rituxan and Zevalin treatments (sorry, but as you know post including links are deleted)

    • "If this requirement is removed, can Zevalin reach $150m/year in USA"
      Maybe in 5 yrs after spending the same amount in marketing/manufacturing the product.
      Not optimistic what so ever in the US market. Its a dud. YOu do realize the COG on zevalin is like 50% of the sales price. Specially manufactured by biogen-idec and it has to go to another specialized nuclear pharmacy/pharmacist to confirm the dosage before getting to a nuclear med department in a hospital to be administered? The cost for SPPI to procure zevalin is almost as worst asProvenge given such low volume.

      "Also, post your thoughts on what it would take to remove this requirement ? lobbying."
      my understanding is that its a NRC license/requirement. I don't know if lobbying would work. people tried in 2006/2007 but to no avail. Zevalin is not too different than Iodine 131 in nuclear medicine, there has to be proper handling and protocals different than a regular cancer ctr/office clinic infusion site.

      "ceo made some big statements that they think this was a major stumbling block to zevalin adoption in Aug/sep, ".
      That is crap, I don't believe him and same like the bio-scanremoval hype. Go back last year and I questioned before the FDA approval what is the big deal with bioscan removal on this message board. The biggest stumbling block is the $$$$. It just comes down to similar clinical efficacy, easy logistics with Rituxan, and a tone more $$$ made administering rituxan and the markup on rituxan.

      Sentiment: Strong Buy

      • 2 Replies to inquisitive808
      • Zevalin (ibritumomab tiuxetan) is a murine anti-CD20 monoclonal antibody covalently bound the chelator tiuxetan which can securely chelate 90Y. We performed a randomized controlled trial comparing Zevalin radioimmunotherapy (RIT) with rituximab immunotherapy in 143 pts with relapsed or refractory low-grade, follicular, or CD20+ transformed B-cell NHL. The primary efficacy variable was ORR. The Zevalin regimen consists of Day 0 and D7 rituximab 250 mg/m[sup2] followed on Day 7 with 0.4 mCi/kg 90Y Zevalin. Control arm pts received 4 weekly doses of 375mg/m[sup2] rituximab. Baseline characteristics were well-balanced. There was no statistical difference between the Zevalin and rituximab groups in median age (60 vs. 57 yrs); histology (follicular 75% vs 83%); median prior therapy regimens (2); bone-marrow involvement (43% vs. 36%); splenomegaly (10% vs. 4%); bulky disease [greater than or equal to] 5 cm (45% vs. 44%), [greater than or equal to] 7 cm (21% vs. 26%), [greater than or equal to] 10 cm (8% vs. 7%); chemotherapy resistance (56% vs 64%); IPI risk group; performance status; or extranodal disease. All pts had acceptable biodistribution and dosimetry estimated radiation absorbed doses to normal organs. Zevalin adverse events were primarily hematologic. Six percent developed Gr 4 thrombocytopenia, 32% Gr 4 neutropenia, and 8% required hospitalization for infection. HAMA incidence was

      • thanks. but i dont understand this part "It just comes down to similar clinical efficacy"

        Zevalin ranks better than rituxan in efficacy for many indications.

    • anyone?

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