Elements for a Public Summary

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1 VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Locally advanced or metastatic bladder cancer Bladder cancer is the sixth most common cancer. It is more common in men than in women. It is more common after the age of fifty. The highest incidence of bladder cancer is generally found in industrially developed countries and in areas associated with endemic schistosomiasis (a parasitic disease) such as Africa and Middle East. PhV Page 80/95

2 RMP version 3.0 Gemcitabine Tobacco smoking is the main risk factor for bladder cancer. Smoking duration and the number of cigarettes smoked daily are directly proportional to the risk. Another important risk factor is the occupational exposure to chemicals, such as aromatic amines used in the manufacture of textile dyes or polycyclic aromatic hydrocarbons which are by-products of combustion. Diesel exhaust is also classified as associated with an increased risk of bladder cancer in cases of high-exposure. Eating fruits and vegetables decreases the risk. Among cancers, bladder cancer reoccurs the most frequently. Locally advanced or metastatic adenocarcinoma of the pancreas Pancreatic cancer is one of the deadliest forms of cancer. It is unusual in persons younger than 45. It is usually diagnosed late and has a poor prognosis. Smoking tobacco is the most important risk factor associated with developing pancreatic carcinoma. Pancreatitis, an inflammatory condition of the pancreas, caused by alcohol abuse among other is associated with increased risk of pancreatic cancer. Other risk factors for cancer of the pancreas are type II diabetes and obesity. Pancreatic cancer has a poor prognosis and the number of deaths closely reflects the number of people being diagnosed. Locally advanced or metastatic non-small cell lung cancer (NSCLC) Lung cancer is the most common cancer worldwide and by far the most common cause of death by cancer. The probability of developing lung cancer remains very low until the age of 39 years. The risk is higher in men. Smoking is the number one risk factor for lung cancer. Radon (a radioactive chemical element) is a human agent involved in causing cancer classified as a cause of lung cancer. It has been estimated that around 21% of lung cancers in men in the UK and around 4% in women are linked to occupational exposures. Asbestos, silica and diesel exhaust have been classified as causal factors. Air pollution is also associated with lung cancer risk The response to treatment depends on the stage of the disease, being better in early stages. Because lung cancer is often insidious it may produce no symptoms until the disease is well advanced. Locally advanced or metastatic epithelial ovarian carcinoma Epithelial carcinoma (cancer that starts in the layers of cells that line hollow organs and glands) of the ovary is one of the most common gynaecologic malignancies and the fifth most frequent cause of cancer death in women, with 50% of all cases occurring in women older than 65 years. The probability of ovarian cancer may be related to the number of ovulatory cycles, and conditions that suppress the ovulatory cycle may play a protective role. The risk of epithelial ovarian cancer is increased in women who have not had children and possibly those with early menarche (the first menstrual bleeding) or late menopause. Oral contraceptives (OCs) are an established protective factor for ovarian cancer. The use of hormone replacement therapy has been associated with an increased risk of ovarian carcinoma. Family history plays an important role in the risk of developing ovarian cancer. The prognosis depends on the stage of the disease at diagnostic. Unresectable, locally recurrent or metastatic breast cancer Worldwide, breast cancer is the most frequently diagnosed life-threatening cancer in women and the leading cause of cancer death among women. The risk of breast cancer increases with age. In terms of genetic predisposition, there are two genes that are associated with greatly increased risk: BRCA1 and BRCA2. As in the case of ovarian cancer, early onset of menstruation and late menopause increase the risk. Older age at first pregnancy and never giving PhV Page 81/95

3 RMP version 3.0 Gemcitabine birth are potential risk factors as pregnancy and breastfeeding decrease a woman's lifetime number of menstrual cycles and the exposure to endogenous (produced within the body) reproductive hormones. Also, the risk of breast cancer declines with the number of children borne. The relationship between oral contraception and the risk of breast cancer is not clear and results of studies are contradictory. Overall, the risk of breast cancer appears to increase with oral contraceptive use unlike the risk of ovarian cancer. Hormone replacement therapy is also associated with increased risk of breast cancer. VI.2.2 Summary of treatment benefits Bladder cancer For patients with inoperable locally advanced or metastatic bladder cancer the MVAC regimen (methotrexat+vinblastine+doxorubicin+cisplatin) is the standard treatment. Gemcitabine in combination with cisplatin showed response rates and median survival comparable to MVAC but with less toxicity. In a study involving 42 patients who have not previously undergone chemotherapy were treated with cisplatin followed by gemcitabine. An objective response was found in 42% of 38 evaluable patients and a complete response in 18%. A phase III study that compared gemcitabine used in combination with cisplatin (GC) with an alternative chemotherapy regimen methotrexate + vinblastine + doxorubicin + cisplatin (MVAC) found that the GC regimen was safer. Pancreatic cancer For patients with locally advanced or metastatic disease gemcitabine has been established as the standard first choice therapy. A study program involving more than 3000 patients with pancreatic cancer revealed that 12% of patients treated with gemcitabine responded and their lives were prolonged with 4.8 months on average. A large study comparing gemcitabine with weekly 5-fluorouracil chemotherapy, performed in 126 patients newly diagnosed with advanced pancreatic cancer, found a significant increase in clinical benefit rand survival for gemcitabine. Non-small-cell lung cancer (NSCLC) A review of experimental studies had found that 52% of 332 evaluable patients treated with gemcitabine for advanced NSCLC, experienced an improvement in performance status. Two large studies indicated that in patients with inoperable, locally advanced or metastatic non-small cell lung cancer gemcitabine monotherapy is at least as active but better tolerated than the combination cisplatin-etoposide. A study using gemcitabine in combination with cisplatin in patients with advanced NSCLC found a total of 11 out of 26 patients who achieved responses. Another study found a higher response for the combination of gemcitabine with cisplatin than for cisplatin alone. Ovarian carcinoma Although the response rate to first-line chemotherapy is relatively high, the majority of patients treated for advanced epithelial ovarian cancer will unfortunately relapse. Patients who relapse more than 6 months after initial chemotherapy are considered platinum sensitive and have the greatest number of potential options for second-line therapy. The combination gemcitabine/carboplatin may be considered alongside other regimens for second-line therapy in platinum sensitive recurrent ovarian cancer patients. A study involving 26 patients with recurrent ovarian cancer and a treatment-free interval of 6 months, found that 63% of them responded to the gemcitabine containing regimen. Based on the results from this study, a phase III trial was initiated to compare the efficacy of gemcitabine plus carboplatin with carboplatin alone in patients with platinum-sensitive recurrent ovarian cancer. A total of 356 women with recurrent ovarian cancer at least 6 months after completion of first-line therapy were administered gemcitabine plus carboplatin or car- PhV Page 82/95

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9 RMP version 3.0 Gemcitabine Major changes to the Risk Management Plan over time Version Date Safety Concerns Comment Not approved Important identified risks Hematologic toxicity Severe skin reactions Pulmonary toxicity Hypersensitivity Cardiac toxicity Renal Toxicity (Haemolytic Uremic Syndrome) Interaction with radiotherapy Capillary leak syndrome Posterior reversible encephalopathy syndrome First version submitted. Important potential risks Reproductive and developmental toxicity (including male infertility) Missing information Experience with gemcitabine in the paediatric population Information on clear dosage for hepatic or renal impairment 3.0 The list or important safety concerns and missing information had been modified in accordance with the innovator: Important identified risks: Myelosuppression Severe skin reactions Pulmonary toxicity Hypersensitivity Haemolytic Uremic Syndrome Radiosensitisation Capillary leak syndrome Posterior reversible encephalopathy syndrome All sections related to the important safety concerns were modified accordingly Important potential risks Mutagenicity Reproductive and developmental toxicity (including male infertility) Missing information Experience with gemcitabine in the paediat- PhV Page 88/95

10 RMP version 3.0 Gemcitabine Version Date Safety Concerns Comment ric population Information on clear dosage for hepatic or renal impairment PhV Page 89/95

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