Spectrum Pharmaceutecals Inc (SPPI)

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Translated (and excellent) Zevalin article provided by Kyelion on another business board. Lot of good stuff here that I would like to discuss in the future. Even though Zevalin is not a big money maker, it's an exciting drug. Sad that the NRC has put a major crimp in doctors being able to administer the drug.

Zevalin: available again with good results and new indications
The radiopharmaceutical Zevalin (ibritumomab tiuxetan yttrium-90) becomes available in the market in two clinical applications: follicular lymphoma and diffuse large cell lymphoma B. In this regard, several recent publications with long follow guarantee their good performance, ability to reduce the cycles of chemotherapy and the potential interest that their use might have for the elderly, frail patients considered.

The Zevalin radiopharmaceutical becomes available on the market. Its indications are: 1) consolidation therapy after remission in adult patients with follicular lymphoma who have not been treated previously and 2) treatment of adults with follicular non-Hodgkin lymphoma CD20 + B cells in relapsed or refractory to rituximab.
Zevalin is supplied as ibritumomab tiuxetan (IT) for radiolabeling with yttrium-90 ( 90 Y-IT). Relaunch coincides with the publication of the results of several independent studies with longer follow - up and very positive results.
The assay Stefoni et al. (2016) corresponds to a multicenter phase II study with patients older than 55 years Diffuse large B-cell lymphoma untreated. The 90 Y-IT was given after four cycles of R-CHOP -in front six or eight ordinary work . The followed for 7 years. The results confirm efficacy and safety of this combination chemotherapy and radiotherapeutic considered fragile patients, with a survival rate at the end of the study than 40%.
For its part, the work presented by Illidge et al. (2016) gives results of a phase II trial evaluating the efficacy and toxicity in the administration of a short course of immunotherapy followed by radiotherapy in patients with recurrent follicular lymphoma. In this case only three cycles of R-CHOP or R-CVP administered followed by90 Y-IT. The response rate reached 98% and survival was 77% at 5 years with little haematological toxicity reported.
The most interesting of both publications is the possibility to reduce the cycles of chemotherapy and total treatment time, from which it may particularly benefit the elderly.
Another recent publication, signed by specialists of the Miguel Servet Hospital in Zaragoza (Andrade-Campos et al., 2016), contains an analysis of 242 patients with non - Hodgkin lymphoma -96 of them treated with 90 Y-IT- to assess a possible increase in the incidence of secondary neoplasms in exposure to radiation. The results confirm that there are no differences between the two groups (untreated and treated with 90 Y-IT).
On the other hand, an update of Dr. Shimoni (Shimoni and Zwas, 2016) provides a 5 - year follow - up randomized phase II study comparing the Zevalin-BEAM conditioning versus BEAM conditioning in association with autologous transplantation in patients relapse of non - Hodgkin lymphoma. The results in this case showed a higher survival rate for the group of Zevalin-BEAM during the 5 years after transplantation.
Although Zevalin-BEAM is currently off-label in relapse patients with large B-cell lymphoma, it is already underway a Phase III (SPINOZA) study to determine this use.
This scenario suggests that Zevalin could become a first-line option in the near future.
Information provided by Andres Varela Argent, Key Account Manager at Spectrum Ph. Sepropharm. Edited by Kalispera medical writing

References:
• Andrade-Campos, M et al . , Long-term complication in follicular lymphoma: Assessing the risk of secondary neoplasm in 242 Patients Treated or not with 90-ibritumomab-tiuxetan yttrium- . Eur J Haematol. 2016; doi: 10.1111 / ejh.12775.
• Illidge, TM et al. Short duration immunochemotherapy followed by radioimmunotherapy consolidation is effective and well tolerated in Relapsed follicular lymphoma: 5-year results from a UK National Cancer Research Institute Lymphoma Group study. Br J Haematol. 2016; 173: 274-82.
• Stefoni, V . Et al, Short-course R-CHOP followed by (90) Y-ibritumomab tiuxetan in previously untreated elderly high-risk diffuse large B-cell lymphoma Patients: 7-year long-term results. Blood Cancer J. 2016; 6: e425.
• Shimoni, A et al., A randomized study Comparing yttrium-90 ibritumomab tiuxetan (Zevalin) and high-dose BEAM chemotherapy alone versus BEAM as the conditioning regimen before autologous stem cell transplantation in Patients With aggressive lymphoma . Cancer. 2012; 118: 4706-14.
• Shimoni, A and Zwas, ST. Radioimmunotherapy and Autologous Stem-Cell Transplantation in the Treatment of B-Cell Non-Hodgkin 's Lymphoma. Semin Nucl Med 2016.; 46: 119-25.

http://www.semnim.es/index.php/noticias/detalle/zevalin-disponible-de-nuevo-con-buenos-resultados-y-nuevas-indicaciones