Pemetrexed (Alimta ®), first oncolítico approved in Europe as maintenance treatment of continuation for the most common lung cancer type.

Indianapolis, United States, November 2011- Lilly has announced that the European Commission has granted approval for the use of pemetrexed (Alimta ®) as single-agent for continued maintenance therapy in patients with lung cancer non–small (NSCL) advanced not scaly. The approval is based on the results of the trial clinical showing an improvement in progression-free survival, and a trend of improvement of the survival overall preliminary analysis in patients with NSCLC treated in first line with pemetrexed and cisplatin followed immediately by treatment with pemetrexed in monotherapy in the maintenance phase.

Pemetrexed is the first chemotherapeutic agent approved as maintenance of continued treatment. In this context, patients whose disease has responded or stabilised at the end of the first line treatment can receive continued maintenance treatment with pemetrexed in monotherapy and get an additional benefit.-

maintenance of continuation with pemetrexed therapy is designed to benefit a group of patients with one of the forms more deadly lung cancer)(lung cancer not scaly non–small) which have not shown a progression to the first line with pemetrexed. Although there are other available guidelines for treatment of maintenance for the NSCL, these involve different medications in the first line and maintenance phases.

This last approval of pemetrexed represents an important advance in the treatment of advanced lung cancer ”, says Dr. Allen Melemed, M.D., M.B.A., senior medical director of Lilly Oncology. personalized treatments are at the forefront of cancer treatment because they enable doctors to select the most appropriate treatment for each patient. With pemetrexed as continuation maintenance treatment of patients with lung cancer who have already benefited from the first line treatment now will also have the option of continuing treatment with pemetrexed, to achieve an improved clinical outcome ”.

This adoption of pemetrexed was based on the results of the PARAMOUNT, a phase III study, double-blind and randomized, presented in the Congress annual of the American Society of Clinical Oncology (ASCO) in June 2011 (1). This study evaluated whether maintenance of continuation with pemetrexed therapy improved progression-free survival and overall survival after treatment of induction with pemetrexed + cisplatin in patients with advanced non-squamous NSCLC. The study reached its primary objective of progression-free survival and a preliminary analysis has shown a positive trend with respect to overall survival.

Patients receiving therapy for induction standard with four cycles of pemetrexed (500 mg/m2) and cisplatin (75 mg/m2), with cycles of 21 days. 939 Patients with advanced non-squamous NSCLC who were recruited and received induction therapy, 539 patients progression-free and with a good general State were then randomly allocated to receive one of the two treatments of maintenance; either pemetrexed (500 mg/m2 the first day of a 21-day cycle) with the best support treatment (n = 359), either placebo with the best support treatment (n = 180) until disease progression. All patients received vitamin B12, folic acid and dexamethasone.

In addition to this new indication, pemetrexed is approved in Europe and United States for other three indications in patients with non-squamous NSCLC advanced, including the first and second lines of treatment, and maintenance treatment of change in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed has also been approved, in combination with cisplatin, in Europe and United States for the treatment of patients with malignant pleural mesothelioma irresecable and no prior chemotherapy.

On the treatment of maintenance at the NSCL

Maintenance therapy is a relatively new concept in the treatment of lung cancer. According to this concept, patients initiated maintenance treatment immediately after the first line therapy to try to maintain control of the disease. There is no therapy of continued maintenance ” in which the used chemotherapy agent is the same that was used previously in the first line. Adopted this date maintenance in lung cancer therapies using different agents at the stage of first-line or in the maintenance.

About the non-small-cell lung cancer (NSCLC)

In general, lung cancer is the most common form of cancer and the most lethal, causing 1.3 million deaths a year (2) between 85-90 percent of all lung cancers are not microcíticos (3). The liver, bones and the brain are potential targets for these cancer cells when they enter the bloodstream.

The NSCL encompasses a group of histologías or types of tumour are distinguished by their cellular structure. Non-squamous histology includes adenocarcinoma, and large cell carcinoma, adding more than half of all diagnoses of CPNM4, as well as the qualified histologías as other ”.

About Lilly Oncology

For more than four decades, Lilly Oncology, a division of Lilly, is dedicated to presenting innovative solu-organizations that improve the care of patients with cancer. Because there are no two equal cancer patients, Lilly Oncology is committed to the development of new approaches to treatment.

On Lilly

Lilly, a company based on innovation, is developing one growing portfolio of produc-pharmaceutical cough through the application of research more Cap made both by its own laboratories around the world as well as through collaborations with scientific organizations of presti-gio. Headquartered in Indianapolis, Indiana, Lilly provides answers to some of the needs more urgent médi-cas worldwide through the supply of medicinal products and information.

Referencia:

(1) Paz-Ares LG, De Marinis F, Dediu M, et to the. PARAMOUNT: phase III study of maintenance pemetrexed (pem) plus best supportive care (BSC) versus placebo plus BSC immediately following induction treatment with pem plus cisplatin for advanced, nonsquamous non-small cell lung cancer (NSCLC). J Clin Oncol 29: 2011 abstr CRA7510 (Suppl.).

(2) World Health Organization, Gender in Lung Cancer and Smoking Research, Department of Gender, Women and Health, 2003, (July 25, 2011).

(3) American Cancer Society, “What Is Non – Small Cell Lung Cancer?,” December 16, 2010, American Cancer Society, (April 20, 2011).