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Rossana Berardi

Dr. Rossana Berardi MD

Consultant Medical Oncologist, UNIVERSITA' POLITECNICA DELLE MARCHE

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GLG News by Dr. Rossana Berardi MD, Consultant Medical Oncologist

Analyses are solely the work of the authors and have not been edited or endorsed by GLG.

Cost will be the tricky point...

August 22, 2009

IRESSA (Gefitinib) Receives Marketing Authorisation for the Treatment of Non-Small Cell Lung Cancer in Europe | www.pipelinereview.com

I believe that, considering the other available agents, gefitinib could be prescribed to up to 1/3 of NSCLC patients...

Another option in NSCLC...?!?

July 2, 2009

IRESSA (Gefitinib) Receives Marketing Authorisation for the Treatment of Non-Small Cell Lung Cancer in Europe | www.pipelinereview.com

The approval of Iressa in NSCLC, opens the way to another therapeutic option in advanced NSCLC.  

Iressa: will it be a new therapeutic option or will it replace another existing option?

May 4, 2009

IRESSA (Gefitinib) Recommended for Approval for the Treatment of Non-Small Cell Lung Cancer in Europe | www.pipelinereview.com

The recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the EMEA recommending to grant a marketing authorisation for Iressa in NSCLC, opens the way to another therapeutic option in advanced NSCLC.

Another good result for Roche.

March 23, 2009

UPDATE 1-Roche's Herceptin prolongs stomach cancer survival | www.reuters.com

The results from ToGA, a large international phase III trial, showed the benefit of herceptin plus chemotherapy vs chemotherapy alone as the first therapy for patients with advanced unresectable gastric cancer.  

A Novel Option for Management of Malignant Ascites.

March 23, 2009

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE: SUMMARY OF POSITIVE OPINION FOR REMOVAB | www.emea.europa.eu

Catumaxomab is a trifunctional monoclonal antibody with 2 antigen-recognition sites: one for human EpCAM, a cell surface antigen expressed by a variety of epithelial tumor cells, and one for human CD3, a T-cell surface antigen. In addition, another region of the antibody binds to receptors that are expressed on other cells of the immune system.

The nth proof...

February 16, 2009

A Randomized Phase IIIB Trial of Chemotherapy, Bevacizumab, and Panitumumab Compared With Chemotherapy and Bevacizumab Alone for Metastatic Colorectal Cancer | www.ncbi.nlm.nih.gov

The trial showed that the addition of panitumumab to bevacizumab and oxaliplatin- or irinotecan-based chemotherapy results in increased toxicity and decreased PFS. This is a new demonstration that the association of anti-EGFR and anti-angiogenic drugs is toxic and ineffective. 

Each Country is different...

February 9, 2009

Limits on Medicare's Ability to Control Rising Spending on Cancer Drugs | content.nejm.org

The cost for cancer drugs is increasing, but big differences among the different Countries are present.

Are nexavar prescriptions increasing?

February 9, 2009

Nexavar® Effective for Hepatocellular Carcinoma in Asians | patient.cancerconsultants.com

Nexavar confirms its efficacy for hepatocellular carcinoma also in the Asian population.

E-prescriptions are not available in all the Countries.

February 9, 2009

Incentives Push More Doctors to E-Prescribe | online.wsj.com

In Italy e-prescription is well away from being available.

It is not so terrible, but...

February 2, 2009

Eli Lilly reports 4Q loss on ImClone costs | finance.yahoo.com

Obviously Lilly will survive and the situation is not so terrible, but  in oncology at least in Europe...

HPV vaccination: do we have to think twice?

January 26, 2009

Merck’s Gardasil Should Not Be Mandatory: Report | www.pharmalot.com

HPV vaccine in Italy is recommended and free for 12-year old girls, but recently several petitions have been presented in order to think back to this vaccination due to the fact that safety and effectiveness are not clear enough.

Maintenance therapy in NSCLC: the jury is still out?

January 26, 2009

Tarceva successful as maintenance therapy | www.fiercebiotech.com

Tarceva (as well as Alimta) has shown interesting results in the maintenance setting. Nevertheless will an increase of only a few weeks in PFS justify its use (and the cost) or will we need to wait for survival data?

Positive reults in Japanese with gastric cancer can be extended to the Western population?

January 20, 2009

Afinitor(R) Phase II trial results positive in patients with advanced gastric cancer after failure of one or more prior treatments | www.pipelinereview.com

Afinitor (everolimus) is a promising drug in several solid tumors. Results of the phase II trial in gastric cancer are interesting, but they have been obtained in Japanese population.

Strategy of treatment in mCRC

January 15, 2009

Merck Serono: Study Published In JCO Shows Erbitux Enhances Efficacy In MCRC Patients With KRAS Wild-Type Tumors In 1st-Line Setting | www.medicalnewstoday.com

Patients with k-ras wild type can obtain good response from cetuximab. The introduction of cetuximab in the first line setting plays an important role in the global strategy of mCRC. In Europe the coming approval of panitumumab may also change the sequence of therapy in the above mentioned setting of disease.

Caution in drawing conclusions

January 15, 2009

Merck KGaA: Overall Survival in First-Line NSCLC Reaches 15 Months | www.drugs.com

Unfortunately the results of the FLEX trial presented at ASCO meeting in 2008 do not seem amazing for a medical oncologist who treat NSCLC patients. Therefore it could be very useful to select patients who can receive real benefits from erbitux in combination with chemotherapy. Skin toxicity may represent an easy clinical parameter which can help the oncologists in this situation, nevertheless several flaws need to be considered.

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