What is Foscan?
Foscan is a solution for injection that contains the active substance temoporfin (1 or 4 mg / ml).
What is Foscan used for?
Foscan is used to relieve the symptoms of advanced stage squamous cell carcinoma of the head and neck (a type of cancer that starts in the cells that line the mouth, nose, throat or ear). It is used in patients with other treatments are no longer effective and are not suitable for radiotherapy (radiation treatment), surgery or systemic chemotherapy (drugs used in the treatment of cancer; "systemic" means that they are intended to act on the whole body).
The medicine can only be obtained with a prescription.
How is Foscan used?
Foscan should only be administered in a specialized cancer center, where a team can evaluate the patient's treatment under the supervision of a physician experienced in photodynamic therapy (treatment that uses the action of light). Treatment with Foscan is a two-step process: the drug is first administered and then activated using a laser. The medicine is given through a permanent intravenous cannula (a thin tube inserted permanently 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 should be illuminated, up to 0.5 cm beyond the surrounding margin, with a light generated by a laser source at a specific wavelength for approximately 3 minutes and 20 seconds. using a fiber optic cable. Each area of tumor tissue should be illuminated only once during each treatment. During treatment the other areas of the body should be shielded from light, so that the drug is activated only on the tumor. If a second cycle is required, it should be done 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 throughout the body, including the tumor mass. When it is illuminated with the laser light at one
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 cells by reacting with their components (proteins and DNA) and destroying them. By limiting the illumination to the tumor, only the tumor cells are damaged, without affecting other parts of the body.
How has Foscan been studied?
Foscan has been studied in four main studies involving a total of 409 patients with head or neck cancer. The first three studies aimed to examine whether the cancer was cleared after up to three courses of treatment with Foscan in a total of 189 patients. The fourth study focused on symptom reduction in 220 patients with advanced head and neck cancer who could not undergo surgery or radiotherapy. In all studies, response to treatment was assessed between the 12th and 16th weeks following the last cycle with Foscan; however, Foscan was not compared with any other drugs.
What benefit has Foscan shown during the studies?
The results of the first three studies did not seem sufficient to corroborate the efficacy of Foscan in the eradication of head and neck cancers. On the other hand, in the study that evaluated the improvement of symptoms in patients with advanced stage head and neck cancer, 28 patients (22%) 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 the patients involved in this study.
What is the risk associated with Foscan?
The most common side effects with Foscan (seen in more than 1 in 10 patients) are pain at the injection site, in the tumor or in the face, bleeding, scarring, necrosis of the mouth (death of cells or tissue in the mouth) , dysphagia (difficulty swallowing), face edema (swelling) and constipation. For the full list of side effects reported with Foscan, see the package leaflet.
Foscan must not be used in people who may be hypersensitive (allergic) to temoporfin or any of the ingredients. Foscan must not be used in patients with porphyria (inability to metabolise porphyrins), other diseases exacerbated by light, porphyrin allergy, or tumors that are spreading to a blood vessel or are close to the site of illumination. Foscan should also not be given to patients who are to undergo surgery within the next 30 days, to patients with an eye disease that requires a "slit lamp" evaluation (a tool used by ophthalmologists to look inside the eye). "eye) for the next 30 days or to patients who are already being treated with another medicine that increases sensitivity to light.
For six months following Foscan injection, patients should avoid exposure to bright light to avoid the risk of skin burns. For further 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 relieving symptoms associated with advanced head and neck cancer were noteworthy. Therefore, the Committee decided that the benefits of Foscan are greater than its risks for the 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, surgery or systemic chemotherapy. The Committee recommended release. of the marketing authorization for Foscan.
Foscan was initially authorized under "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 the "exceptional circumstances" was removed on May 21, 2008.
Other information about Foscan:
On 24 October 2001, the European Commission issued a "marketing authorization" for Foscan, valid throughout the European Union. The "marketing authorization" for
trade was renewed on 24 October 2006. The holder of the marketing authorization is the company Biolitec Pharma ltd.
For the full version of the Foscan EPAR click here.
Last update of this summary: 05-2008
The information on Foscan - temoporfin published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
