Oxaliplatin is a diaminocyclohexane (DACH) platin.
Oxaliplatin, the active substance of Eloxatin®/Elplat®, has dramatically changed the prognosis of colorectal cancer, which prior to the introduction of oxaliplatin in the mid nineties, could be treated by 5-fluorouracil (5-FU) only.
Oxaliplatin in combination with 5-FU allowed to more than double the survival of patients with metastatic disease (from 10 months with FU alone to more than 20 months in various therapies including oxaliplatin). Later in the early 2000, oxaliplatin has significantly increased the number of patients cured by chemotherapy in so-called adjuvant settings (i.e. immediately after the surgery and before the development of metastases). Oxaliplatin has thus been a major advance in the history of the treatment of this very aggressive disease.
In summary, oxaliplatin (associated with 5-FU) has become a worldwide standard of care in metastatic colorectal cancer and is also used in combination for the treatment of other solid tumours.
Current status
- A major Sanofi-Aventis prescription drug
- Indications: early and advanced stages of metastatic colorectal cancer
- Licensees: Sanofi-Aventis (Eloxatin®), Yakult (Elplat®), Dr Reddy’s Laboratories (Dacotin®), Pfizer (Dacplat®)
Eloxatin® History
Licensed-in
In 1989, from Nagoya City University
Status at in-licensing
Clinical phase I
Debiopharm value added
- Developing oxaliplatin and working in particular on its efficacy-safety ratio
- File submission in France (Reference Member State)
- 15 patent families covering process, combination, formulation and use
- Continuous life cycle management
Timelines
- First approval of the lyophilised formulation obtained in Europe in 1996 within seven years of in-licensing
- Record 46-day Food and Drug Administration (FDA) approval in 2002 in the United States
- Approval in Japan in 2005 (Elplat®)
- Approval of the aqueous formulation in 2005 in the US
- Approval of the aqueous formulation in 2004 in France, in 2005-2006 in most other European countries
- Approval of the aqueous formulation in Japan in 2009
