What is Foscan?
Foscan is a solution for injection containing the active substance temoporfin (1 or 4 mg / ml).
What is Foscan used for?
Foscan is indicated to attenuate the symptoms of squamous cell carcinoma of the head and neck (a type of tumor that starts from the cells that line the mouth, nose, throat or ear) at an advanced stage. It is used in patients whose other treatments are no longer effective and who are not suitable for treatment with radiotherapy (radiation treatment), surgery or systemic chemotherapy (drugs used in the treatment of cancer; "systemic" means that they are destined to act on the whole organism).
The medicine can only be obtained with a prescription.
How is Foscan used?
Foscan should only be administered in a center that specializes in treating cancer, where a team can evaluate the patient's treatment under the supervision of a doctor with experience in photodynamic therapy (a treatment that exploits the action of light). Treatment with Foscan is a two-step process: the drug is first administered and subsequently activated using a laser. The medicine is administered through a permanent intravenous cannula (a thin tube permanently inserted into a vein) in a single slow injection over a period of not less than six minutes. The dose is 0.15 mg per kilogram of body weight. Four days later, the entire area affected by the tumor must be illuminated, up to 0.5 cm beyond the surrounding margin, with a light generated by a laser source at a specific wavelength for about 3 minutes and 20 seconds, using a fiber optic cable. Each area of tumor tissue should be illuminated only once during each treatment. During the treatment the other areas of the body must be shielded from the light, so that the medicine is activated only on the tumor. If a second cycle is required, it must be carried out with a minimum interval of four weeks.
How does Foscan work?
The active ingredient contained in Foscan, temoporfin, is a photosensitizing agent (substance that changes when exposed to light). After the injection of Foscan, temoporfin is distributed in the body, including the tumor mass. When illuminated with one laser light
given wavelength, temoporfin is activated and reacts with the oxygen present in the cells, creating a highly reactive and toxic type of oxygen. It kills the cells by reacting with their components (proteins and DNA) and destroying them. By limiting illumination to the tumor, only cancer cells are damaged, without affecting other parts of the body.
What studies have been carried out on Foscan?
Foscan has been studied in four main studies involving a total of 409 patients with carcinoma of the head or neck. The first three studies aimed to examine whether the tumor was eliminated after a maximum of three Foscan treatment cycles out of a total of 189 patients. The fourth study focused on reducing symptoms in 220 patients with advanced head and neck carcinoma who could not undergo surgery or radiation therapy. In all the studies, the response to treatment was evaluated between the 12th and 16th week following the last Foscan cycle; However, Foscan has not been compared with other drugs.
What benefit has Foscan shown during the studies?
The results of the first three studies were not sufficient to support the effectiveness of Foscan in the eradication of head and neck carcinomas. Instead, in the study evaluating symptom improvement in patients with advanced head and neck carcinoma 28 patients (22%) out of the 128 subjects observed showed a significant improvement in the most troublesome symptoms. A reduction in tumor size was also observed in about a quarter of patients involved in this study.
What is the risk associated with Foscan?
The most common side effects with Foscan (seen in more than 1 patient in 10) are pain at the site of the injection, at the level of the tumor or on the face, bleeding, scarring, necrosis of the mouth (death of cells or tissue in the mouth), dysphagia (difficulty in swallowing), edema of the face (swelling) and constipation. For the full list of all side effects reported with Foscan, see the Package Leaflet.
Foscan should not be used in people who may be hypersensitive (allergic) to temoporfin or any of the ingredients. Foscan should not be used in patients with porphyria (inability to metabolize porphyrins), other diseases exacerbated by light, an allergy to porphyrins or tumors that are spreading to a blood vessel or that are near the lighting site. Foscan must also not be given to patients who need to undergo surgery for the next 30 days, to patients suffering from an eye disease that requires a "slit lamp" assessment (an instrument used by ophthalmologists to look inside the eye). eye) in the following 30 days or to patients who are already being treated with another medicine that increases sensitivity to light.
In the six months following the injection of Foscan, patients should avoid exposure to bright light to avoid the risk of skin burns. For more details, see the package leaflet.
Why has Foscan been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that the effects of Foscan in mitigating the symptoms associated with advanced head and neck cancer were noteworthy. Therefore, the committee decided that Foscan's benefits outweigh its risks for palliative treatment of patients with advanced squamous cell carcinoma of the head and neck who have failed previous therapies and are not suitable for radiotherapy treatment, surgery or systemic chemotherapy. The committee recommended that Foscan be given marketing authorization.
Foscan was initially authorized in "exceptional circumstances" because, due to the fact that the disease is rare and for scientific reasons, information was scarce at the time of authorization. As the company provided the additional information requested, the restriction on "exceptional circumstances" was lifted on 21 May 2008.
More information on Foscan:
On 24 October 2001, the European Commission issued a marketing authorization for Foscan, valid throughout the European Union. Authorization for entry into
trade was renewed on 24 October 2006. The marketing authorization holder is Biolitec Pharma ltd.
The full EPOR for Foscan can be found here.
Last update of this summary: 05-2008
