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Posts with tag GlaxoSmithKline

GSK's Cervarix drug gets support from Europe

GlaxoSmithKline's Cervarix cervical cancer drug is closer to approval in Europe after an influential medical panel there Wednesday afternoon suggested the drug be approved.

GSK expects EU approval in the coming months, with a European Cervarix launch possibly in 2007 sometime. Cervarix assists in the prevention of pre-cancerous lesions in the cervix caused by the human papillomavirus (HPV), which has been a center of contention as certain states in the U.S. have suggested mandatory vaccinations for teenage girls against the HPV.

Cervical cancer is the second-most common form of cancer in women after breast cancer worldwide. So far, Cervarix has not received approval by the FDA in the U.S.

GlaxoSmithKline to launch five new cancer drugs

Five new cancer treatments are in the works and could be available for use as early as 2010, thanks to GlaxoSmithKline, PLC, the world's second largest drug company.

The drugs will treat a range of different cancers -- one will be cervical cancer -- and are known as cervarix, pazopanib, promacta, rezonic, and ofatumumab.

"Over the next three years, GSK will make a difference to millions of patients facing cancer," said Glaxo's head of research and development, Moncef Slaoui.

Glaxo's most recent cancer drug is Tykerb, an oral breast cancer treatment launched in March.

Diet drug Xenical renamed Alli, still a cancer worry

Prescription weight-loss drug Xenical hit drugstore shelves on Friday with a new name -- Alli (pronounced: "Al-eye") and with a new non-prescription strength. The newly-named drug is to be more effective with less unpleasureable side effects. Still, there's a problem surrounding this drug, regardless of its name. It's thought to cause colon cancer.

The nonprofit group Public Citizen says Alli, made by GlaxoSmithKline, has been shown in mice studies to cause pre-cancerous lesions in the colon. Since there are no long-term studies on humans, this group believes the FDA should not have approved the drug for non-prescription use. It's not clear whether or not the pre-cancerous spots will lead to colon cancer but the mere suggestion that it might is enough, says a Public Citizen spokesperson.

"What we do know is that these lesions occur much more frequently in people who do get colon cancer," he said. "Why do we recommend that everyone get a colonscopy at the age of 50? Because you pick up on these polyps when you do one. And, even though not all of the polyps are pre-cancerous, no (doctor) does a colonscopy without removing every single polyp that is found. And you do this because you know if you don't, it greatly increases the chances of getting cancer."

Continue reading Diet drug Xenical renamed Alli, still a cancer worry

Cervical cancer vaccine, Cervarix, slowed by FDA

The Food an Drug Administration is not going to grant a priority review to GlaxoSmithKline's experimental cancer vaccine Cervarix. Adding pressure is recent controversy surrounding its diabetes drug Avandia.

Cervarix will now have to go through a standard 10-month review, instead of going the fast-track route. GlaxoSmithKline is defending its diabetes drug after a study published in the New England Journal of Medicine said that those taking the drug are at greater risks of heart attacks.

GlaxoSmithKline expects to market the drug Cervarix in the United States sometime in 2008.

GlaxoSmithKline seeks breast cancer drug approval

The breast cancer drug Tykerb may be one of the future wonder drugs available for women left with limited options for treating advanced-stage disease.

Tykerb, manufactured by British-based GlaxoSmithKline PLC, is currently an experimental drug that delays growth of tumors nearly twice as long as standard chemotherapy in patients who no longer respond to Herceptin -- a targeted drug that significantly decreases chances of recurrence for women with HER2 positive breast cancer. Herceptin blocks the swift growth of an aggressive protein on the cell's surface while Tykerb does its work on the inside of the cell. Herceptin is given intravenously. Tykerb is given in pill form.

Two previous posts -- one in April and one in June -- relfect the progress of Tykerb as reported in the media. With each new report, Tykerb seems to gain momentum and promise. And this past week, new reports revealed new promise as Glaxo began seeking regulatory approval of the Tykerb pill in Europe.

Glaxo has filed an application with the Food and Drug Administration for approval of this drug and is preparing to market the drug for the treatment of advanced breast cancer in women. Glaxo hopes to launch Tykerb -- also known as lapatinib ditosylate -- next year.

Tykerb makes headlines as new breast cancer wonder drug

Someone once told me to think of cancer as a chronic condition -- an illness like diabetes or asthma that may linger for life and may require continual treatment. And while battling cancer, perhaps for life, I should just hope that medical advances occur and new treatments become available. And maybe, just maybe, the science of medicine will decrease by leaps and bounds the number of people who die from cancer.

During my own battle with cancer -- which has been 18 months long -- two new breast cancer drugs have hit the scene with rave reviews from researchers and medical professionals. This is good news for me because my type of breast cancer makes me a candidate for both drugs. Herceptin is one of these drugs -- given to women who are HER-2/neu positive -- that's me -- and over express a protein that makes the tumor aggressive. Herceptin is received over 52 weeks -- and I go every three weeks for a 90-minute infusion of this clear liquid that causes me really no side effects at all. It can be toxic to the heart but monitoring tests have revealed that my heart is not suffering at this time. And with just three more infusions to go -- one this Wednesday -- I will likely encounter no adverse reactions to this potentially life-saving drug.

And now Tykerb is making headlines. Tykerb, suggested for use with advanced breast cancer and manufactured by British-based GlaxoSmithKline PLC, is an experimental drug that delays the growth of tumors nearly twice as long as standard chemotherapy in patients who no longer respond to Herceptin. This finding, reported this past Saturday at a meeting in Atlanta of the American Society of Clinical Oncology, confirms initial findings about the promise of this drug -- that like Herceptin, made by Genentech, precisely targets tumors without killing lots of healthy cells. The difference between the two drugs is that Herceptin blocks the protein on the cell's surface and Tykerb does it inside the cell -- blocking a second abnormal protein too. And while Herceptin is given intravenously, Tykerb is given in pill form -- which may make it cheaper and easier to use.

While now part of an international study, Tykerb may be available to women in the United States later this year. And it perhaps will be offered in conjunction with Herceptin or instead of Herceptin for women with advanced breast cancer.

I hope I do not ever need Tykerb -- and that Herceptin alone will be enough for me -- but it is comforting to know that there is something else out there. Something that if necessary, just might help me live with this potentially chronic condition called cancer.

Tykerb: new breast cancer drug showing remarkable results

GlaxoSmithKline announced it has received positive data from an interim analysis of its Phase III trial of Tykerb in advanced breast cancer, and as such, ended enrollment for the trial after it found Tykerb in combination with Xeloda delayed the time to disease progression by more than 50 percent, compared to Xeloda alone.

None of the breast cancer patients in the trial had responded to Herceptin or other drugs.

“We are extremely encouraged by this data which suggest that Tykerb may offer significant benefit as an oral medication in combination with chemotherapy for patients with advanced or metastatic breast cancer, and whose disease has progressed on previous treatment regimens, including Herceptin,” said Paolo Paoletti, M.D., Senior Vice President of the Oncology Medicine Development Center at GlaxoSmithKline.

At this time, Tykerb is an experimental drug that does not have regulatory approval in any country for any use outside of clinical trials. GlaxoSmithKline plans to file marketing applications for Tykerb with the Food and Drug Administration and European regulators in the second half of the year.

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