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EU Approvals: Eloxatin, Raptiva, Alimta, Xenical

Yael Waknine

Sept. 28, 2004 — The European Commission has approved the following drugs for use in the European Union: oxaliplatin in the adjuvant treatment of stage III colon cancer, efalizumab for moderate to severe chronic plaque psoriasis, pemetrexed in combination with cisplatin for malignant pleural mesothelioma, and pemetrexed monotherapy as second-line therapy for non-small cell lung cancer. In addition, the 2.5-kg pretreatment weight loss requirement has been removed from the label for orlistat.

Oxaliplatin (Eloxatin) for Adjuvant Treatment of Stage III Colon Cancer in EU

On Sept. 17, a successful completion of the Mutual Recognition Procedure in Europe resulted in an expanded indication for oxaliplatin (Eloxatin, made by Sanofi-Aventis), allowing its use in the European Union for the adjuvant treatment of stage III (Duke's C) colon cancer after complete resection of the primary tumor.

The approval was based on the phase III results of the Multicenter International Study of Oxaliplatin/5-Fluorouracil/Leucovorin (5-FU/LV) in the Adjuvant Treatment of Colon Cancer (MOSAIC) trial, showing that the addition of oxaliplatin to 5-FU/LV significantly increased disease-free survival at three years compared with 5-FU/LV alone (72.2% vs. 65.3%; 24% decrease in risk of recurrence) in patients with completely resected stage III colon cancer.

The addition of oxaliplatin to 5-FU/LV was well tolerated, neutropenia being the most frequently reported adverse effect and complicated by fever or infection in 1.8% of cases. Patients experiencing peripheral sensory neuropathy showed total or partial recovery within six months after treatment.

Oxaliplatin was previously approved in the EU and by the U.S. Food and Drug Administration for first- and second-line treatment of metastatic carcinoma of the rectum or colon. Approval for the extended indication is being applied for in the U.S. and in other countries.

Efalizumab (Raptiva) for Moderate to Severe Chronic Plaque Psoriasis in EU

On Sept. 23, the European Commission approved efalizumab (Raptiva, made by Serono) for use in the European Union. The drug is indicated in the treatment of adult patients with moderate to severe chronic plaque psoriasis in patients having inadequate or inappropriate response to other systemic treatments (cyclosporine, methotrexate) or phototherapy.

Efalizumab is a monoclonal antibody designed to selectively and reversibly block the activation, reactivation, and trafficking of T cells that lead to the development of psoriasis symptoms. It is administered by subcutaneous injection once weekly.

Efalizumab (Raptiva, made by Genentech) was approved by the U.S. Food and Drug Administration in October 2003 for the treatment of moderate to severe chronic plaque psoriasis in adults aged 18 years or older who are candidates for systemic therapy or phototherapy.

Pemetrexed (Alimta) for Malignant Pleural Mesothelioma and NSCLC in EU

On Sept. 22, the European Commission approved pemetrexed (Alimta, made by Lilly) for use in the European Union. Pemetrexed is indicated in combination with cisplatin for the treatment of malignant pleural mesothelioma in patients who have not received prior chemotherapy and are not candidates for surgery. Pemetrexed is administered with vitamin B12 and folic acid to reduce the frequency and severity of adverse effects without compromising its cytotoxic effects.

The approval was based on the results of a global clinical trial showing that the addition of pemetrexed to cisplatin increased overall survival by 30% (12.1 months vs 9.3 months) and one-year survival by 12.3% (50.3% vs. 38.0%) compared with cisplatin alone.

Adverse events associated with the drug combination include disorders of the blood and lymphatic system, gastrointestinal disorders, fatigue, nervous system sensory disorders, renal and urinary disorders, rash, and hair loss.

Pemetrexed was also approved in the EU as second-line monotherapy in the treatment of non-small cell lung cancer. The approval was based on the results of a phase III global clinical trial showing that pemetrexed demonstrated survival and overall response rates comparable to those of docetaxel, with a significantly improved adverse effect profile.

Pemetrexed was associated with a significantly decreased incidence of grade 3 or 4 neutropenia (5.3% vs 40.2%; P < .001), neutropenia with fever requiring hospitalization (1.5% vs 13.4%; P < .001), and hair loss (6.4% vs 37.7%; P < .001) compared with docetaxel, although increased transient elevations in alanine transaminase were noted (1.9% vs 0.0%; P = .028).

Adverse events for pemetrexed used as a second-line monotherapy for non-small cell lung cancer included disorders of the blood and lymphatic system, gastrointestinal disorders, fatigue, rash, and desquamation.

Pemetrexed is currently approved by the U.S. Food and Drug Administration in the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy, and for use in combination with cisplatin in the treatment of malignant pleural mesothelioma.

Pretreatment Weight-Loss Requirement Removed From Orlistat (Xenical) Label in EU

On Sept. 21, the European Commission approved the use of orlistat (Xenical, made by Roche) in an expanded population by removing the 2.5-kg pretreatment weight-loss requirement from the European label. This allows physicians in the European Union to provide patients with immediate access to treatment.

The requirement was originally intended to help physicians identify patients most likely to respond to treatment; it was rescinded based on the results of studies showing that weight loss after three months of orlistat therapy is the best predictor of weight loss at one year.

Orlistat is currently approved by the U.S. Food and Drug Administration for use in obesity management, including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. The U.S. label does not include a pretreatment weight-loss requirement.

Reviewed by Gary D. Vogin, MD

FDA Approves Lung Cancer Drug Alimta

(AP)10/28,2004 - The Food and Drug Administration approved a cancer drug made by pharmaceutical giant Eli Lilly and Co. to treat advanced non-small cell lung cancer in patients who have undergone chemotherapy.

According to the American Cancer Society, non-small cell lung cancer is the leading cause of cancer-related deaths in the nation. By the time most patients arrive for treatment, the cancer is widespread.

The drug, Alimta, in clinical trials was found to shrink tumors as effectively as another cancer drug, Taxotere. But Alimta did so with fewer troubling side effects, including hair loss, depressed blood count and hospitalizations for subsequent infection.

The treatment, 500 mg every 21 days, costs patients $3,900 per month, according to the company.

"There's no question, the survival was comparable to the survival with the best drugs we have," said Dr. Paul Bunn, director of the University of Colorado Cancer Center and principal investigator for several of the drug's clinical trials. "As a doctor, this drug is as good as anything else we have. It does benefit patients."

Alimta Improves Life of Lung Cancer Patients

A new version of an old class of chemotherapy drugs offers a better quality of life than the standard medication used for patients with recurrent lung cancer, researchers say.

Alimta® will likely benefit many non-small cell lung cancer patients because the majority of the 174,000 Americans diagnosed with the disease each year experience a recurrence, says Roy Herbst, M.D., chief of Thoracic Oncology at M. D. Anderson.

"Lung cancer is a very devastating disease and the therapies can be hard on patients," Herbst says. “While this new drug does not seem to increase survival at this late stage compared to the current standards, patients have far fewer side effects.”

Nationwide trial finds advantages over standard

Herbst and his M. D. Anderson colleagues took part in a nationwide clinical trial that led to the Aug. 19 approval of Alimta by the Food and Drug Administration. Under the direction of Frank Fossella, M.D., professor in the Department of Thoracic/Head & Neck Medical Oncology, the group tested the drug in 20 patients and found it offered significant benefits.

The trial compared Alimta withTaxotere, the current standard therapy for recurrent non-small cell lung cancer, and found that patients taking Alimta had fewer alternations in their blood counts and fewer side effects than those taking Taxotere. Side effects from Taxotere include myelosuppression, anemia, fatigue, anorexia and infection.

In fact, researchers found that only one in 50 patients taking Alimta had significant side effects, and that it can reduce tumor size as well as Taxotere.

Herbst says Alimta, already used for mesothelioma treatment since earlier this year, is now being used at M. D. Anderson for lung cancer. “We are beginning to offer it to patients,” he says. “Alimta is permitted for use in patients with stage 3 or 4 small-cell lung cancer who have had prior but unsuccessful chemotherapy treatment.”

Herbst says his group is also planning to open future clinical trials at M. D. Anderson using Alimta, including a study that will test it in combination with radiation therapy for treatment of lung cancer. He also suggests that it can someday potentially be used in first line therapy for non-small cell lung cancer based on data from his group.

Drug improves vitamin supplements

Alimta is a refinement of one of the oldest classes of chemotherapy drugs known as “anti-folates” that block folate, a B vitamin involved in making new genetic material. While it reduces the ability of cancer cells to reproduce and grow, the therapy can also harm normal cells, so patients are given extra supplements of folate and B12, to reduce the drug’s toxicity.

“If you supplement this drug with vitamin B12 and folate, the patients do extremely well,” Herbst says. An added benefit is that the drug is given to patients through an intravenous catheter in a procedure that lasts only ten minutes, and is administered only once every three weeks.

The drug’s possibilities have expanded to other diseases. Alimta also received FDA approval to treat malignant pleural mesothelioma, a type of lung cancer associated with asbestos exposure. M. D. Anderson researchers also participated in clinical trials that led to approval of use of Alimta for mesothelioma.

“It is a promising drug that will further help our patients who suffer from this all too common and devastating disease,” Herbst says.

Alimta Approved in the European Union for Two Cancer Indications

First and Only Chemotherapy Approved for Malignant Pleural Mesothelioma and New Option for a Common Form of Lung Cancer

INDIANAPOLIS (USA), 22 Sep. (PRNewswire) -

Eli Lilly and Company announced today that its chemotherapy agent, Alimta(R) (pemetrexed), has been granted marketing authorization by the European Commission (EC) for two distinct cancer indications. This regulatory first for Lilly, means that Alimta can be offered to two patient groups each battling devastating forms of cancer. The product launch and availability of Alimta will vary in each European Member State.

Alimta, in combination with cisplatin, now becomes the first and only approved chemotherapy in the European Union to help patients with malignant pleural mesothelioma live longer(1). Alimta, given as a single agent, is also an important new second-line treatment for patients suffering from non-small cell lung cancer(2).

"Alimta represents a true breakthrough in cancer care pushing the boundaries of conventional therapies with an innovative scientific approach. Alimta provides efficacy and when given with folic acid and B12 offers controlled side effects. Vitamin supplementation helps patients remain healthy enough to complete the full-recommended course of therapy -- increasing the opportunity Alimta has to work," said Christian Manegold, M.D., Professor at Ruprecht-Karls-University and a consultant in Hematology/Oncology for the Thoracic Hospital in Heidelberg, Germany. "By providing a balance of proven efficacy and controlled side effects, Alimta will help positively change the way chemotherapy is perceived."

Cytotoxic chemotherapy, which kills cells to combat cancer, has been the foundation of advanced cancer therapy for decades. Alimta, a cytotoxic chemotherapy, is a novel multitargeting antifolate that simultaneously blocks at least three separate enzymes essential to the survival of cancer cells. A team of researchers led by Lilly discovered that vitamin supplementation of folic acid and B12 given with Alimta significantly reduces the frequency and severity of the drug's side effects without compromising its ability to kill cancer cells.

Specifically, Alimta was approved today in combination with cisplatin, a common chemotherapy agent, for the treatment of malignant pleural mesothelioma (MPM), a cancer in the lining of the lungs for patients who have not received prior chemotherapy and are not candidates for surgery. Alimta was also approved as a single agent therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after previous chemotherapy. The administration for Alimta is a convenient 10-minute infusion, once every three weeks.

"We are extremely pleased by the European Commission's approval of Alimta in Europe. This is an historical day -- two patient groups benefit from today's approval," said Edmundo Muniz, M.D., Ph.D., oncology leader at Lilly. "We now have a very strong non-small cell lung cancer franchise led by Gemzar in the first-line metastatic setting and Alimta in the second-line metastatic setting. Oncology is an area of tremendous unmet medical need, and we are committed to being a leader in developing new therapies for patients."

Clinical research of Alimta is ongoing in first-line non-small cell lung cancer and in combination with radiation. Small cell lung, breast, colon, ovarian and gastric cancers are also being researched.

Alimta for Malignant Pleural Mesothelioma Patients

Malignant pleural mesothelioma is a rare cancer of the lining of the lungs. The disease is often associated with asbestos exposure and has a long latency period -- usually between 20 and 40 years. Most people are not diagnosed until the cancer is in advanced stages and treatment with surgery or radiation is not an option. It is estimated that between 10,000 and 15,000 people around the world are diagnosed annually with malignant pleural mesothelioma.

The now approved combination of Alimta and cisplatin was compared to cisplatin alone in a clinical trial of 448 patients from 19 countries -- the largest trial to date among patients with malignant pleural mesothelioma. Results showed overall survival increased 30 percent (12.1 months for Alimta/cisplatin versus 9.3 months for cisplatin alone), and that 50.3 percent of patients treated with Alimta/cisplatin were alive a year later compared to 38.0 percent treated with cisplatin alone(1). Both the median and one-year advantages seen with the combination regimen of Alimta plus cisplatin were statistically significant.

The most common side effects when Alimta is used in combination with cisplatin are disorders of the blood and lymphatic system, gastrointestinal disorders, fatigue, sensory disorders of the nervous system, renal and urinary disorders, rash and hair loss.

Alimta in Non-Small Cell Lung Cancer

According to the 2003 World Health Organization Cancer Report, lung cancer is the world's most common cancer and the leading cause of cancer death for both men and women. There will be 1.2 million cases diagnosed this year around the world. The number of patients receiving treatment beyond the first-line in non-small cell lung cancer is steadily increasing and new therapy options are desperately needed in this setting.

Alimta was studied in a Phase III global clinical trial, the largest ever reported in second-line NSCLC, involving 571 randomized patients whose non-small cell lung cancer advanced beyond the first chemotherapy regimen. Among the patients enrolled in this study, 288 received docetaxel (75 mg/m2 on day one of a 21-day cycle; one-hour infusion) and 283 received Alimta (500 mg/m2 on day one of a 21-day cycle; 10-minute infusion; supplemented with vitamin B12 and folic acid). The primary endpoint was overall survival and secondary endpoints included toxicity, response rate, and progression-free survival.

In this study Alimta showed a survival rate comparable to that of docetaxel but with a more favorable side effect profile. Alimta caused significantly less neutropenia (an abnormal decrease in white blood cells) and hospitalization for neutropenia with fever, as well as less hair loss compared to docetaxel.

Patients on Alimta compared to therapy with docetaxel did show an increased transient elevation in Alanine Transaminase (ALT), a laboratory measurement of liver function. When Alimta is given as a single agent the most common side effects include disorders of the blood and lymphatic system, gastrointestinal disorders, fatigue, rash and desquamation (peeling of the skin).

Patients With Asbestos-Related Cancer Report Better Quality of Life With Alimta+Cisplatin

CHICAGO--(BUSINESS WIRE)--June 2, 2003--

Earlier Findings Showed That Alimta+Cisplatin Helped These Same Patients Live Longer

Patients enduring an agonizing form of cancer often associated with asbestos exposure reported that the combination of Alimta(R) (pemetrexed) and cisplatin enabled them to enjoy a better overall quality of life, compared to cisplatin alone.

The findings - unveiled today at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago - come on the heels of data presented at last year's ASCO meeting indicating that Alimta+cisplatin enabled these same exact patients to live longer than if they received cisplatin alone.

"Patients with advanced cancer should not have to choose between feeling better and living longer," said Richard Gralla, M.D., a noted thoracic cancer expert and president of the New York Lung Cancer Alliance, who presented the findings. "Patients, and we as health care professionals, want both."

Gralla characterized the findings as "very good news" in developing a potential treatment for malignant pleural mesothelioma, a disease in which a tumor - caused by asbestos fibers - lodges between the chest wall and lung cavity. "This is a terrible disease with a high mortality rate and is associated with several debilitating symptoms, including crushing chest pain and difficulty breathing," said Paolo Paoletti, M.D., vice president of oncology products at Eli Lilly and Company, which is developing Alimta.

At least 10,000 people worldwide are diagnosed with malignant pleural mesothelioma each year, according to conservative estimates. However, that figure is expected to increase because malignant pleural mesothelioma has a long latency period - 20 to 50 years. There is currently no approved therapy for this disease.

The survival and quality of life data for Alimta resulted from a Phase III randomized study of 448 patients with malignant pleural mesothelioma from 19 countries. Of these patients, 226 received Alimta + cisplatin (a common chemotherapeutic agent) and 222 received cisplatin only.

As previously reported, results showed that combining Alimta with cisplatin increased patients' median survival by 30 percent (12.1 vs. 9.3 months, a finding that was statistically significant). No other chemotherapy studied in malignant pleural mesothelioma, including cisplatin alone, has been able to exceed the six-to-nine month life expectancy for patients diagnosed with this disease.

The quality of life data were reported in detail today for the first time. The data were obtained from the same 448 patients who were tracked for survival.
According to this analysis, patients treated with a combination of Alimta and cisplatin experienced significantly less pain and difficulty breathing, among other symptoms. "Not only is their life prolonged by this treatment, but their quality and enjoyment of it is improved," said Michael Boyer, M.D., head of the department of medical oncology at the Sydney Cancer Center in Australia. "People who were no longer able to do the things they enjoy are once again able to participate in life."

More About The Study

In this study, 77 percent of patients had Stage III-IV, or advanced, disease.
The study's primary endpoint was survival. Quality of life, which takes into account a patient's physical, psychological and social functioning, was a secondary endpoint.

In gathering quality of life data, researchers used an instrument known as the LCSS- Meso Scale. This scale is based on the Lung Cancer Symptom Scale (LCSS), a validated and widely used instrument for measuring quality of life in patients with lung cancer.

In addition to rating their overall level of quality of life, patients were also asked to rate five specific symptoms associated with their disease: pain, shortness of breath, fatigue, appetite loss, and cough. At least 90 percent of patients stated they had at least three of these symptoms.

According to the results, all comparisons favored the Alimta+cisplatin arm versus the cisplatin-alone arm. In particular, patients reported that the extent of their pain, shortness of breath and cough was significantly better by week 12, or after four cycles of treatment with Alimta+cisplatin, compared to cisplatin alone. These improvements persisted through two other measured periods of time: week 15 (five cycles of treatment) and week 18 (six cycles of treatment). In this study, evaluation was completed at the end of week 18.

Patients' level of fatigue was significantly better by week 15 and lasted through week 18 (the end of the evaluation period). In sum, according to the researchers, by week 18, significantly more patients on the Alimta+cisplatin arm reported better quality of life compared to patients on cisplatin only. As with the findings on survival, these results reached the level of statistical significance (p= 0.012).

The most common side effect of Alimta+cisplatin therapy observed in this 448-patient study was a decrease in white blood cell counts (technically known as neutropenia), but the rate of serious infection was very low. The severity of neutropenia, as well as other side effects, including diarrhea and painful mouth ulcers, was significantly ameliorated by folic acid and vitamin B12 supplementation.

In the United States, Alimta is in the process of a rolling submission to the U.S. Food and Drug Administration (FDA) for use, with cisplatin, in the treatment of malignant pleural mesothelioma. In the meantime, in cooperation with the FDA, Lilly has provided Alimta free of charge to more than 600 patients with mesothelioma as part of an expanded access, or compassionate use, program. Similar programs are underway in other countries around the world as well. "This is simply the right thing to do," said Paoletti. "Until now, patients could really only look forward to a steady downhill course. Now, patients with malignant pleural mesothelioma have access to a treatment that offers a chance of having an impact on the course of their disease."

For more information about the expanded access program in the U.S., physicians may call 1-866-347-9503 (patients are asked to work through their physicians). Additionally, information can be found at www.ClinicalTrials.gov, a service of the National Institutes of Health. Key Word: mesothelioma. For information on expanded access programs involving Alimta and mesothelioma in additional countries, patients are encouraged to have their doctors send an email to Alimta@Lilly.com.

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs

Lilly's drug for cancer 'exciting'

Indianapolis Star, IN - Jun 2, 2003

The experimental cancer drug Alimta worked so well in a study on lung cancer patients that Eli Lilly and Co. said Monday it will ask for federal approval to market the drug for that use, too.

Tapping the large market for lung cancer, which is diagnosed in 175,000 Americans every year, could vastly expand sales possibilities for Alimta. Up to now, Lilly had planned to target the drug only for mesothelioma, a rare cancer of the lung lining caused by asbestos exposure.

Alimta's effectiveness in treating the most common form of lung cancer could amount to "a huge benefit for patients and also for health care," said Dr. Paolo Paoletti, Lilly vice president of clinical research for oncology.

The Indianapolis drug maker revealed the new Alimta findings at the annual meeting of the American Society of Clinical Oncology in Chicago.

In the Lilly-sponsored study, Alimta proved as effective as Taxotere as a second-line treatment for non-small cell lung cancer. Taxotere, made by Aventis and sold since 1999, is the only federally approved drug to treat recurring cases of the common lung cancer in patients who've been unsuccessfully treated with first-line chemotherapy.

Survival was largely the same, at about eight months, for both Taxotere and Alimta patients.

Not only did Alimta match Taxotere in effectiveness, Alimta caused far fewer side effects among the 571 lung cancer patients studied.

Only 5 percent of patients taking Alimta saw a dangerous drop in white blood cells, compared with 40 percent of patients on Taxotere. A low white blood cell count can lead to fever or infection.

In addition, only 10 percent of patients given Alimta suffered serious drug-related adverse events, compared with 24 percent of Taxotere patients.

Fewer side effects should make Alimta a more useful drug for patients and doctors, said Dr. Nasser Hanna, an assistant professor of medicine at Indiana University School of Medicine, who presented the study findings.

Alimta sales geared mainly toward mesothelioma could hit $157 million by 2006, said the investment firm Friedman Billings Ramsey & Co. But last year, the investment firm Lehman Bros. forecast peak annual sales for Alimta of $1 billion, assuming it's used against multiple cancers, a dollar figure that would put Alimta among Lilly's top-selling drugs.

Lung cancer in its most common form typically kills its victims within eight months of diagnosis, so avoiding serious drug-induced side effects during that time is important for patients and their families, Hanna said.

In the study, Alimta was supplemented with vitamin B-12 and folic acid, but Hanna said the vitamins alone didn't account for the fewer side effects.

About a half-dozen drugs are approved as first-line treatments for common lung cancer. They include another Lilly product, Gemzar, and the well-known Taxol, from Bristol-Myers Squibb Co.

But those products often only slow down lung cancer's spread, so new treatments are needed, Hanna said. "This opponent we face is so difficult. Whenever we get another drug, that's exciting."

Lilly will use the new study to ask the Food and Drug Administration to approve Alimta for common lung cancer, as well, which would significantly expand the drug's market.

"That would be my dream. But it's in the hands of the FDA," Paoletti said.

In earlier studies, Alimta proved its worth in lengthening the lives of patients stricken with mesothelioma, which is diagnosed in 10,000 people worldwide annually. No drugs are currently approved in the United States to treat the deadly cancer caused by airborne asbestos. Lilly expects to receive FDA approval late this year or early 2004 to sell Alimta for mesothelioma.

Lilly is filing for approval at a favorable time for what would be its second cancer drug. Under pressure to get new cancer treatments to market, the FDA has speeded up its approval process, approving some drugs even before the last of three stages of human testing is complete.

Alimta came out of the Princeton University labs of Edward C. Taylor, an emeritus professor of organic chemistry. A synthetic compound, Alimta works against cancer by interfering with the way natural folic acid is converted into enzyme co-factors necessary for cancer cell division.

Alimta is given intravenously. In the lung cancer study, patients underwent a 10-minute infusion every three weeks.

Lilly has FDA approval to supply Alimta for free on a compassionate-use basis to more than 600 mesothelioma patients. Lilly makes the drug in Europe