Physicians' Financial News for July/August 2007

By Querida Anderson
Published: Thursday, Jul 08, 2010
%u25BA GSK to Bring Five New Medicines to Market in the Next Three Years

GlaxoSmithKline (GSK) has announced plans to launch five drugs by 2010. “GSK has truly taken a balanced approach to the research we have done in oncology and the portfolio that we have built,” remarked Debasish Roychowdhury, MD, Vice President, Global Clinical Development for the Oncology Medicine Development Centre.

The drugs that will come to market, according to GSK, will include NCEs, biopharmaceuticals and vaccines for prevention of cancer like Cervarix, treatments as in Pazopanib for renal cell carcinoma and supportive care like Promacta in thrombocytopenia. Additionally, Rezonic is being evaluated for treating emesis and Ofatumumab in NHL/CLL.

On top of these five potential launches, GSK recently gained approval for Tykerb in the U.S. and Switzerland. The drug is indicated for advanced or metastatic breast cancer patients whose tumors overexpress HER2 and who have received prior therapy. This includes treatment with Genentech’s Herceptin.

“Tykerb is a dual kinase inhibitor and also binds to the EGFR,” Dr. Roychowdhury explained. “Herceptin is a monoclonal antibody and is only available in an IV formulation, while Tykerb is a small molecule that is administered orally. Additionally, data presented for Tykerb at ASCO 2007 suggest that Tykerb may cross a compromised blood-brain barrier.”

Tykerb is being evaluated in the first-line, adjuvant and neoadjuvant settings of breast cancer treatment, in the prevention and treatment of brain metastases, in hormone receptor positive patients and other EGFR and HER2 expressing tumors, including a Phase III trial in head and neck cancer. Over 1,200 patients have been enrolled in the Phase III TEACH (Tykerb Evaluation After CHemotherapy) adjuvant study, GSK reported.

Next, GSK plans to file Promacta for approval to treat short-term ITP by the end of 2007 or early 2008. If sanctioned, it will be the first oral novel compound for thrombocytopenic patients. Phase III data on Promacta confirms increased platelet count and signifi- cantly lower incidence of bleeding in patients with ITP. GSK is investigating Promacta for the treatment of Hepatitis C-associated thrombocytopenia and chemotherapy-induced thrombocytopenia (CIT).

Also planned for the first half of 2008, is the filing of Rezonic for post-operative and chemotherapy-induced nausea and vomiting. Data show that the drug in combination with Zofran is superior to Zofran alone, GSK reported.

Pazopanib currently is in registration studies in renal cell carcinoma. Development programs for combination therapy and monotherapy in eight other cancer types are underway, including sarcoma and ovarian cancer.

Turning to the biologics in GSK’s oncology pipeline, Dr. Rowchowdhury said, “We are pursuing a robust clinical development program for Ofatumumab, a fully humanized, high-affinity monoclonal antibody that targets the CD20 molecule on the cell membrane of B cells and is in late stage development for the treatment of a number of serious conditions. We also have other biologics in early development and with the acquisition of Domantis, GSK now has an even stronger discovery and development program in biologics.” Ofatumumab is being evaluated in follicular NHL and CLL.

Soon advancing into Phase III trials is MAGEA3 ASCI (Antigen-Specific Cancer Immunotherapeutic), a novel vaccine to treat NSCLC. The registration trial, involving over 2,200 patients, will be the largest clinical trial ever conducted in this indication, according to GSK. To date, the company added, no active specific immunotherapies are approved by the FDA.


GlaxoSmithKline Oncology Pipeline



    Drug   Cancer Type
Phase I   4 Compounds   Various types of cancer
Phase II       pazopanib

  Tykerb
  breast cancer
    pazopanib


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Community Practice Connections™: Bridging the Gaps Around Oncology Biosimilars: Assessing the Potential Impact of Emerging Agents to PracticeSep 29, 20181.5
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