The past week has seen a mixture of positive and negative developments in Europe and the UK for chronic lymphocytic leukaemia (CLL), hepatocellular carcinoma (HCC) and non-small cell lung cancer (NSCLC).
Of particular interest, the UK's National Institute for Health and Clinical Excellence (NICE) has issued a recommendation for the use of Roche's MabThera (rituximab) in CLL. NICE's final guidance recommends rituximab in combination with fludarabine and cyclophosphamide chemotherapy (CT) as an option for previously-untreated patients with CLL. Professor John Gribben, Consultant Haematologist and Medical Oncologist, Barts and The London NHS Trust, commented: "the ability to add rituximab to chemotherapy is a major advance in the way we can treat CLL. Where previously our goal was just to improve symptoms, for the first time we now have a treatment combination that is capable of producing much higher remission rates and more durable responses."
Further, the EMEA's CHMP has issued a positive recommendation for the use of MabThera in patients with relapsed or refractory CLL. Physicians will soon be able to prescribe MabThera in combination with CT to patients in Europe who have been treated for the disease, but whose cancer has returned or have not appropriately responded to therapy.
Separately, the anticipated decision from NICE on the Final Appraisal Determination for Bayer HealthCare/Onyx Pharmaceuticals' Nexavar (sorafenib), for the treatment of advanced HCC, has been delayed to allow consideration of the patient access scheme, Bayer Schering Pharma has agreed with the Department of Health. The company hopes that NICE will take this opportunity to evaluate and fully understand the benefit of its proposed patient access scheme, and to listen to leading healthcare professionals in the field who were unanimous in their condemnation of the initial negative proposal.
Finally, the CHMP has adopted a negative opinion for the use of Erbitux (cetuximab) in combination with platinum-based CT for the treatment of patients with EGFr-expressing, advanced or metastatic NSCLC. Merck KGaA is evaluating potential appeal options requesting that the CHMP re-examines data demonstrating clinically-relevant benefits to patients. This has come as a huge blow to Merck, with its shares plummeting 12 per cent following the decision.
Alice Rossiter - Cancer Drug News Editor
Showing posts with label MabThera. Show all posts
Showing posts with label MabThera. Show all posts
Tuesday, July 28, 2009
Tuesday, June 17, 2008
Ten years of rituximab
As MabThera (rituximab) reaches ten years of market availability in Europe for the treatment of non-Hodgkin's lymphoma (NHL), what does the future hold for the monoclonal antibody (MAb)?
Approved in June 1998 by the EC, although launched earlier in the US (where it is known as Rituxan), rituximab (formerly IDEC-C2B8) was the first anticancer MAb, heralding an influx of the molecules into treatment regimens for multiple tumour types. Originally discovered by IDEC (now Biogen Idec) and jointly developed along with Genentech, Roche and Zenyaku Kogyo, the MAb targets the CD20 protein that is expressed on over 95 per cent of B-cell lymphomas. It was the first MAb therapy to demonstrate a clinically-significant antitumour response, which finally provided proof of principle that these molecules could be efficacious, as well as specific and less toxic. Such a combination of attributes has seen rituximab realise significant revenue, with sales of US$2,252 million in 2006 and US$2,515 million in 2007.
Rituximab was initially approved to treat only a specific subset of patients with NHL. Over the years, the MAb has gained approval to treat additional types of NHL and has become a front-line therapy when used in combination with various chemotherapy regimens. But what about the future of the MAb? Ongoing clinical studies are investigating the long-term use of rituximab as a maintenance therapy to prevent relapse in patients with follicular lymphoma. These trials have shown that maintenance therapy prolongs the duration of remission and that the MAb can be safely administered for up to two years. Additionally, rituximab is in Phase III trials for relapsed and first-line chronic lymphocytic leukaemia. Rituximab has also been approved in areas outside of oncology, such as for the treatment of rheumatoid arthritis, and is being investigated as a therapy for lupus, multiple sclerosis and platelet disorders.
Sales of rituximab look set to remain at a steady level for the next five years, however, in April 2007, Dr Reddy's Laboratories launched Reditux, its brand of rituximab, in India. Reditux, for the treatment of NHL, is priced at around half the originator’s price. Dr Reddy's also announced plans to market Reditux in other markets, including the US, when the product's patent expires in 2015.
The success of rituximab has paved the way for the development and approval of additional anticancer MAbs, treating tumour types such as colorectal, breast, lung, and head and neck cancer. Rituximab has not only altered the way that NHL is treated, but it has significantly changed the approach to cancer drug development. MAb therapies are now an essential part of cancer treatment regimens and clinical trials. Future challenges will involve how to best incorporate new MAb therapies with current treatments, including new forms of immunotherapy. Despite the threat of future biosimilar competition, there is clearly life still left in the original MAb.
Matthew Dennis - Editor, Cancer Drug News
Approved in June 1998 by the EC, although launched earlier in the US (where it is known as Rituxan), rituximab (formerly IDEC-C2B8) was the first anticancer MAb, heralding an influx of the molecules into treatment regimens for multiple tumour types. Originally discovered by IDEC (now Biogen Idec) and jointly developed along with Genentech, Roche and Zenyaku Kogyo, the MAb targets the CD20 protein that is expressed on over 95 per cent of B-cell lymphomas. It was the first MAb therapy to demonstrate a clinically-significant antitumour response, which finally provided proof of principle that these molecules could be efficacious, as well as specific and less toxic. Such a combination of attributes has seen rituximab realise significant revenue, with sales of US$2,252 million in 2006 and US$2,515 million in 2007.
Rituximab was initially approved to treat only a specific subset of patients with NHL. Over the years, the MAb has gained approval to treat additional types of NHL and has become a front-line therapy when used in combination with various chemotherapy regimens. But what about the future of the MAb? Ongoing clinical studies are investigating the long-term use of rituximab as a maintenance therapy to prevent relapse in patients with follicular lymphoma. These trials have shown that maintenance therapy prolongs the duration of remission and that the MAb can be safely administered for up to two years. Additionally, rituximab is in Phase III trials for relapsed and first-line chronic lymphocytic leukaemia. Rituximab has also been approved in areas outside of oncology, such as for the treatment of rheumatoid arthritis, and is being investigated as a therapy for lupus, multiple sclerosis and platelet disorders.
Sales of rituximab look set to remain at a steady level for the next five years, however, in April 2007, Dr Reddy's Laboratories launched Reditux, its brand of rituximab, in India. Reditux, for the treatment of NHL, is priced at around half the originator’s price. Dr Reddy's also announced plans to market Reditux in other markets, including the US, when the product's patent expires in 2015.
The success of rituximab has paved the way for the development and approval of additional anticancer MAbs, treating tumour types such as colorectal, breast, lung, and head and neck cancer. Rituximab has not only altered the way that NHL is treated, but it has significantly changed the approach to cancer drug development. MAb therapies are now an essential part of cancer treatment regimens and clinical trials. Future challenges will involve how to best incorporate new MAb therapies with current treatments, including new forms of immunotherapy. Despite the threat of future biosimilar competition, there is clearly life still left in the original MAb.
Matthew Dennis - Editor, Cancer Drug News
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