Kadcyla by Roche approved in Switzerland for a new indication in patients with early-stage HER2-positive breast cancer

Basel, 24 January 2020

  • Additional approval of Kadcyla based on the phase III KATHERINE study, in which patients with early-stage HER2-positive breast cancer who were treated with Kadcyla had a 50% reduction in the risk of relapse or death compared with the standard therapy Herceptin1
  • Approval of Kadcyla in Switzerland for adjuvant therapy in early-stage breast cancer was obtained using an accelerated approval procedure (advance-notice procedure)

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it had received additional approval for Kadcyla® (trastuzumab-emtansin) from the Swiss Agency for Therapeutic Products (Swissmedic). Kadcyla is now indicated as monotherapy for the adjuvant treatment of patients with early-stage HER2-positive breast cancer, who have residual disease in the breast and/or the lymph nodes following preoperative taxane-containing chemotherapy in combination with at least trastuzumab as HER2-directed therapy.

This positive decision is based on the results of the KATHERINE study:1 these show that patients in whom a tumour is still detectable before surgery after drug therapy (neoadjuvant therapy) have a 50% reduced risk of relapse or death if they are treated after the operation with Kadcyla instead of Herceptin® (trastuzumab).

"The approval of Kadcyla for post-operative treatment is good news for patients with breast cancer in Switzerland", says Dr Jean-Marc Häusler, Medical Director Roche Pharma (Schweiz) AG. "Optimum treatment is vitally important for every patient with early-stage breast cancer. Patients requiring surgery because residual tumour is detectable after the initial drug therapy are at particular risk of relapse. The approval of Kadcyla means that a treatment is now available that can significantly reduce this risk and increase the chance of remission."

The approval came about as a result of an advance-notice procedure, which is faster than the standard approval process. Consequently, authorisation was granted approximately nine months after submission.

KATHERINE study

The approval is based on the phase III KATHERINE study, in which Kadcyla was shown to be significantly superior in patients with early stage breast cancer vis-a-vis the standard therapy, Herceptin, in terms of invasive disease-free survival (iDFS).

Compared with Herceptin therapy, the iDFS rate at 3 years (median monitoring time: 41 months) was increased from 77.0% to 88.3%. This represents a significant and clinically meaningful 50% reduction in the risk of relapse or death (HR: 0.50; 95 %-CI: 0.39 – 0.64; p < 0.001).

About Kadcyla

Kadcyla is an antibody-drug conjugate (ADC) that was developed to deliver effective chemotherapy directly to HER2-positive cancer cells, while as far as possible limiting the damage to healthy tissue.2,3 It combines two cancer-inhibiting treatments, which are attached together by a stable linker: the HER2-targeted qualities of trastuzumab (the active substance of Herceptin) and the chemotherapy agent DM1.4 Kadcyla is the only ADC that is approved in over 100 countries, including the USA and the EU, as the only monotherapy for the treatment of humans with HER2-positive metastasising breast cancer who have previously received Herceptin and taxane-based chemotherapy, either separately or in combination. Roche licenses the technology for Kadcyla under an agreement with ImmunoGen, Inc.

About Roche drugs for the treatment of HER2-positive breast cancer

Roche has been a leader in HER2 research for over 30 years and is committed to improving the health, quality of life and survival chances of people with early and advanced-stage HER 2-positive breast cancer. HER2-positive breast cancer is a particularly aggressive form of the disease, which affects about 15 – 20% of patients.5 Roche has developed three innovative drugs that have revolutionised the treatment of HER2-positive breast cancer: Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kadcyla® (trastuzumab-emtansin). Suitability for treatment with Roche's HER 2-targeted drugs is established by means of a diagnostic test that identifies persons who could probably benefit from treatment with these drugs at the beginning of their disease.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2018 employed about 94,000 people worldwide. In 2018, Roche invested CHF 11 billion in R&D and posted sales of CHF 56.8 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

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References

  1. von Minckwitz G et al. NEJM 2019; 380: 617-628.
  2. Hurvitz SA et al. J Clin Oncol. 2013 ; 31(9): 1157-63.
  3. Verma S et al. N Engl J Med. 2012; 367(19): 1783-91.
  4. Junttila TT et al. Breast Cancer Res Treat. 2011; 128: 347–56.
  5. Wolff AC et al. J Clin Oncol. 2013; 31(31): 3997-4013.