Takeda pleased to receive positive NICE guidance for brentuximab vedotin (ADCETRIS) in relapsed / refractory (R/R) systemic anaplastic large cell lymphoma (sALCL)

NICE decision ensures continuity of access for the majority of patients with R/R sALCL to a medicine that has transformed patient care for this rare cancer since its introduction in 2012.

Takeda is disappointed that NICE has included an access restriction based on ECOG performance status within the FAD without any discussion on the topic at either appraisal committee meeting. This restriction negatively impacts a very small group of patients who may now struggle to gain access to potentially their only viable treatment option.

Takeda UK Ltd, High Wycombe: Thursday 24th August 2017

  • Through hard work, flexibility and determination, Takeda, supported by the clinical and patient community, has successfully overturned previous negative draft guidance published on brentuximab vedotin in the treatment of R/R sALCL.  This ensures long-term access to this vital standard of care ggestreatment for adults with R/R sALCL in England, Wales and Northern Ireland1
  • NICE’s final appraisal document (FAD) states:
    • Brentuximab vedotin is recommended as an option for treating relapsed or refractory systemic anaplastic large cell lymphoma in adults, only if:
      • they have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and
      • the company provides brentuximab vedotin according to the commercial access agreement with NHS England.
    • When using ECOG performance status, healthcare professionals should take into account any physical, sensory or learning disabilities, or communication difficulties that could affect ECOG performance status and make any adjustments they consider appropriate.
  • Takeda believes the inclusion of the ECOG restriction is highly unfortunate and not aligned with clinical experience or consistent with how other medicines for lymphoma have been appraised. There was no discussion on this topic at either of the two appraisal committee meetings and this proposed restriction was not included in the previous ACD for consultation.  Previous access to brentuximab vedotin via the Cancer Drugs Fund (CDF) had no ECOG status restriction and Takeda is not aware on any data that would support this restriction. A very small group of patients could be significantly impacted by this decision and may face a bleak outlook.
  • Brentuximab vedotin is licensed for the treatment of R/R sALCL, a very rare and aggressive T-cell lymphoma that affects less than a 100 patients per year in the UK.  It has been available on the NHS, via the CDF since April 2013 and will now transition to baseline commissioning in the next three months for patients with R/R sALCL and a performance status of 0 or 1.
  • Patient care in R/R sALCL has been transformed following brentuximab vedotin’s introduction.  A 5-year follow up of the phase 2 trial of 58 patients showed an estimated 5-year overall survival rate of 60% (95% CI: 47%, 73%; median OS not yet reached) in comparison to historical data before the availability of brentuximab vedotin that reported a median overall survival of just 3.0 months after relapse in R/R sALCL patients3
  • Professor Tim Illidge of The Christie NHS Foundation Trust, said: “I am delighted that patients can maintain long term access to brentuximab vedotin through this NICE decision.  R/R sALCL  is an aggressive lymphoma that in the past has carried an extremely  poor prognosis when initial therapy has failed and patients would succumb to their disease in a short period.  Brentuximab vedotin has transformed the outlook for such patients since it was made available on the CDF and provides hope of long term survival and improved quality of life”.
  • Jonathan Pearce, chief executive of the Lymphoma Association, said: “We are delighted to learn that NICE has reversed its previous negative draft guidance and recommended brentuximab vedotin for routine use within the NHS in England, Wales and Northern Ireland for patients with R/R sALCL. 

The decision will bring relief to sALCL patients and their families who without brentuximab vedotin would have limited treatment options. It is vital that innovative treatments are being developed and made available to lymphoma patients. We want everyone affected by lymphoma to receive the best possible treatment and care, and the more options there are to improve outcomes and quality of life for patients, the better”.

  • Adam Zaeske, Takeda UK General Manager, said: “At Takeda we are committed to ensuring all eligible patients have access to our medicines and have worked extremely hard to ensure R/R sALCL patients maintain access to brentuximab vedotin.  Overall, we are pleased with the positive NICE decision, however it is disappointing that NICE has added a last minute ECOG restriction that could result in a small number of patients no longer having access to the medicine and being left with limited options. We thank the clinical and patient community for their unwavering support during this complex review process”.

Further information on brentuximab vedotin can be found in the Summary of Product Characteristics (SmPC) 4 and Patient Information Leaflet (PIL) which can be obtained at www.medicines.org.uk

- ends -

CONTACT FOR FURTHER INFORMATION:

Health Unlimited                                                                  

Brendan Manning                                                                  

Mobile: 07432 572152

Direct: 0208 8392 8040                                                         

brendan.manning@unlimitedgroup.com

 

Takeda UK Ltd                                                                     

Audrey Liechti                                                                        

Mobile: 07787 445369

Direct: 01628 537821                                                

Audrey.Liechti@takeda.com             

 

NOTES FOR EDITORS

About lymphoma

Lymphoma is the fifth most common cancer in the UK and is the most common blood cancer. Lymphoma is divided into two major groups: Hodgkin lymphoma and non-Hodgkin lymphoma.5

sALCL is a rare form of non-Hodgkin lymphoma and affects less than 100 patients in the UK each year.  For patients who relapse after initial frontline treatment for sALCL, their prognosis was extremely poor before the introduction of brentuximab vedotin. 3   

The NICE recommendation is for patients who have an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1. These are defined as patients who have no or only minimal restriction in physical activities6.

 

About brentuximab vedotin (ADCETRIS®)

Brentuximab vedotin is an innovative antibody-drug conjugate composed of a CD30-directed monoclonal antibody (recombinant chimeric immunoglobulin G1 [IgG1], produced by recombinant DNA technology in Chinese Hamster ovary cells) that is covalently linked to the antimicrotubule agent monomethyl auristatin E (MMAE). Once inside the cell, the MMAE is released from the antibody and the cancer cell is destroyed. The innovative mechanism of action and precise cancer cell targeting means that patients generally cope better with the side effects. 4,7,8

Brentuximab vedotin was granted a conditional licence in Europe in 2012. A conditional licence is granted to a medicinal product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk, despite the fact that additional data are still required.

Brentuximab vedotin has been approved in Europe for the treatment of adult patients with Hodgkin lymphoma in the following licensed indications:

  1. Relapsed / refractory (R/R) CD30+ve Hodgkin lymphoma following ASCT
  2. CD30+ve Hodgkin lymphoma at increased risk of relapse or progression following ASCT
  3. R/R CD30+ve Hodgkin lymphoma following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option

Brentuximab vedotin is also licensed for the treatment of adult patients with R/R systemic anaplastic large cell lymphoma (sALCL).

 

About Takeda UK Ltd.

Takeda UK Ltd., located in High Wycombe, is the UK marketing and sales organisation of Takeda Pharmaceutical Company Limited, Osaka, Japan. Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as our presence in Emerging Markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.takeda.com/news.

Additional information about Takeda UK Ltd. is available through its corporate website,www.takeda.co.uk, and additional information about Takeda Oncology, the brand for the global oncology business unit of Takeda Pharmaceutical Company Limited, is available through its website, www.takedaoncology.com.

 

References

  1. National Institute for Health and Care Excellence. Final Appraisal Determination.  Brentuximab vedotin for treating relapsed or refractory systemic anaplastic large cell lymphoma [ID 512]. August 2017
  2. Pro B et al. Five-Year Survival Data from a Pivotal Phase 2 Study of brentuximab vedotin in Patients with Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma. Abstract 4144, ASH 2016
  3. Mak et al. Survival of Patients With Peripheral T-Cell Lymphoma After First Relapse or Progression: Spectrum of Disease and Rare Long-Term Survivors. J Clin Oncol 2013: 31; 1970-1976
  4. Adcetris summary of product characteristics July 2017. Available athttp://www.medicines.org.uk/emc/medicine/27173. Last accessed August 2017
  5. Lymphoma Association. About lymphoma. Available at: https://www.lymphomas.org.uk/about-lymphoma last accessed August 2017
  6. Oken, M.M. et al. Toxicity And Response Criteria Of The Eastern Cooperative Oncology Group. Am J Clin Oncol 5:649-655, 1982.
  7. Younes A, Gopal AK, Smith SE, et al. Results of a pivotal Phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin’s lymphoma. J Clin Oncol. 2012; 30(18): 2183-9
  8. Pro B et al. Brentuximab vedotin (SGN-35) in Patients with Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma: Results of a Phase 2 study. J Clin Oncol. 2012; 30(18): 2190-6

To read more Press Release articles, click here.