FDA Approves New Drug to Fight Advanced Prostate Cancer

Xofigo was fast-tracked for approval and is meant for tumors that have spread to the bones

By EJ Mundell

HealthDay Reporter

WEDNESDAY, May 15 (HealthDay News) -- The U.S. Food and Drug Administration announced Wednesday that it has approved a drug to help men with advanced prostate cancer whose disease has spread to the bones.

The drug, Xofigo, is targeted to patients with late-stage, metastatic disease that has spread to the bones but not to other organs, the FDA said in a news release. It is meant for patients who have already undergone surgery and/or drug therapies such as hormone-based treatments.

The FDA said Xofigo was approved more than three months ahead of the original August 2013 deadline the agency had set for a complete review. Instead, the drug was reviewed under the agency's "priority" review program, designated for medicines that appear safe and effective in a context where no good alternative therapy exists.

"Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, explained in the news release.

In a clinical trial involving more than 800 men with symptomatic prostate cancer that was resistant to hormonal therapy and had spread to the bones, men on Xofigo survived a median of 14 months compared to a little over 11 months for men taking a placebo. Side effects from Xofigo included nausea, diarrhea, vomiting and swelling of the legs and feet. Low levels of red and white blood cells, as well as platelets, were also reported among some patients taking Xofigo, the FDA said.

Pazdur noted that "Xofigo is the second prostate cancer drug approved by the FDA in the past year that demonstrates an ability to extend the survival of men with metastatic prostate cancer." The other drug, Xtandi, was approved by the FDA last August for men with hormone treatment-resistant prostate cancers that have spread or recurred, and who had previously been treated with the drug docetaxel.

According to the American Cancer Society, prostate cancer remains the leading cancer type among men outside of skin cancer, and about one man in every six will develop the illness during his lifetime. Caught early, it is often curable. About 239,000 new cases of prostate cancer are diagnosed among American men each year, and nearly 30,000 men die from the disease annually.

Xofigo is co-marketed in the US by Wayne, N.J.-based Bayer Pharmaceuticals and Algeta US of Cambridge, Mass.

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New Drug May Slow Advanced Ovarian Cancer

Study found it prolonged remission after chemotherapy almost six months longer than a placebo

By Dennis Thompson

HealthDay Reporter

SATURDAY, June 1 (HealthDay News) -- Women with advanced ovarian cancer stayed in remission almost six months longer when they were treated with the targeted drug pazopanib (Votrient), new German research says.

"Our findings show that we finally have a drug that can maintain control over ovarian cancer growth achieved through initial treatments," study author Dr. Andreas du Bois, a professor of gynecologic oncology at Kliniken Essen-Mitte in Essen, said in a statement. "If pazopanib is approved for ovarian cancer, many patients will experience longer disease-free and chemotherapy-free periods. During this time, the patient keeps control over the disease, instead of the disease having control over patient's life."

The results were to be presented Saturday at the American Society of Clinical Oncology annual meeting, in Chicago. Research presented at medical meetings is considered preliminary until published in a peer-reviewed journal.

However, other cancer experts warned against placing too much hope in these early findings.

"I would say that it is intriguing, but I think it's important for the public to know this is not a home run," said Dr. Karen Lu, a professor of gynecologic oncology at the University of Texas MD Anderson Cancer Center, in Houston. "This is an incremental step in the right direction. There did not seem to be a survival advantage. It does increase by 5.6 months, on average, the amount of time a woman does not need to be on chemotherapy, but in terms of prolonging survival or increasing the rate of cure, it doesn't reach that standard."

Advanced ovarian cancer is an aggressive disease with a cure rate of only 20 percent to 25 percent, according to background information in the study. It is often referred to as a "silent killer" because it usually is not detected until it has progressed into its later stages. Two of every three patients with advanced ovarian cancer experience a relapse following successful initial treatment with surgery and chemotherapy.

"Ovarian cancer is a difficult disease to treat," explained Dr. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society. "We don't have effective screening, and women present with more advanced disease."

No targeted therapies are currently approved in the United States for maintenance treatment of ovarian cancer.

Pazopanib, which is taken in pill form, works by blocking the growth of tumors and their blood vessels. The U.S. Food and Drug Administration has already approved its use for the treatment of kidney cancer and soft tissue sarcoma. The drug's maker, GlaxoSmithKline, funded this latest research.

In the study, 940 patients with stage III or IV ovarian cancer received either pazopanib or a placebo daily for 24 months. All patients already had gone through surgery and chemotherapy that successfully prevented the disease from worsening.

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Drug Shows Promise Against Advanced Melanoma

In preliminary trial, nivolumab shrank tumors in 30 percent of tough-to-treat patients

By Alan Mozes

HealthDay Reporter

SATURDAY, June 1 (HealthDay News) -- Nearly one-third of patients with advanced melanomas who received nivolumab, a new immune-based drug, experienced reductions in the size of their tumors, a preliminary study reveals.

Since these types of drugs have typically shrunk tumors in only 5 percent to 10 percent of patients in prior studies, the new results are a boost for immunotherapy generally, the researchers noted.

"I think nivolumab is a real breakthrough drug for patients with metastatic melanoma, and probably for other diseases, too," study author Dr. Mario Sznol, a professor of medical oncology at the Yale Cancer Center in New Haven, Conn., said in a news release.

"The high level of activity observed with this drug opens up a number of avenues for future research to understand and challenge the ways tumors evade the immune system. We're very excited that there is potential for even more activity in combination with other drugs," Sznol added.

One expert not connected to the study was also optimistic about the results.

"Nivolumab shows exciting promise for patients suffering from an otherwise fatal disease -- metastatic melanoma," said Dr. Michele Green, a dermatologist at Lenox Hill Hospital in New York City. "The fact that 30 percent of patients showed improvement from this immunotherapy drug is remarkable since these patients had some of the worse disease."

The study was funded by drugmaker Bristol-Myers Squibb and is scheduled for presentation Saturday at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago. Findings presented at medical meetings are typically considered preliminary until published in a peer-reviewed journal.

According to the researchers, nivolumab works by honing in on PD-1 cellular receptors located on immune system T-cells. These receptors are known to function as immune system "gatekeepers," and by working to open such gates the patient's immune system is triggered into cancer-fighting action.

The new study involved 107 patients, all of whom had been previously treated with multiple forms of standard therapies that failed to halt their disease.

Following treatment with one of five different doses of nivolumab, the team found that 31 percent of the patients went on to experience a minimum tumor shrinkage of 30 percent across the various doses.

Forty-three percent of the patients are estimated to have survived two years after treatment, the researchers said, and average survival for patients across all treatment doses is now projected to be nearly 17 months.

In an ASCO news release, melanoma expert Dr. Lynn Schuchter called the results "truly remarkable."

The findings "confirm that 'revving' up the immune system is a powerful approach in shrinking melanoma," said Schuchter, who is also a spokeswoman for ASCO. "Melanoma patients are living longer and better with these new treatments."

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Immune Therapy Shows Early Promise for Advanced Leukemia

Title: Immune Therapy Shows Early Promise for Advanced Leukemia
Category: Health News
Created: 3/20/2013 4:35:00 PM
Last Editorial Review: 3/21/2013 12:00:00 AM

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FDA Approves New Drug to Fight Advanced Prostate Cancer

Xofigo was fast-tracked for approval and is meant for tumors that have spread to the bones

By EJ Mundell

HealthDay Reporter

WEDNESDAY, May 15 (HealthDay News) -- The U.S. Food and Drug Administration announced Wednesday that it has approved a drug to help men with advanced prostate cancer whose disease has spread to the bones.

The drug, Xofigo, is targeted to patients with late-stage, metastatic disease that has spread to the bones but not to other organs, the FDA said in a news release. It is meant for patients who have already undergone surgery and/or drug therapies such as hormone-based treatments.

The FDA said Xofigo was approved more than three months ahead of the original August 2013 deadline the agency had set for a complete review. Instead, the drug was reviewed under the agency's "priority" review program, designated for medicines that appear safe and effective in a context where no good alternative therapy exists.

"Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, explained in the news release.

In a clinical trial involving more than 800 men with symptomatic prostate cancer that was resistant to hormonal therapy and had spread to the bones, men on Xofigo survived a median of 14 months compared to a little over 11 months for men taking a placebo. Side effects from Xofigo included nausea, diarrhea, vomiting and swelling of the legs and feet. Low levels of red and white blood cells, as well as platelets, were also reported among some patients taking Xofigo, the FDA said.

Pazdur noted that "Xofigo is the second prostate cancer drug approved by the FDA in the past year that demonstrates an ability to extend the survival of men with metastatic prostate cancer." The other drug, Xtandi, was approved by the FDA last August for men with hormone treatment-resistant prostate cancers that have spread or recurred, and who had previously been treated with the drug docetaxel.

According to the American Cancer Society, prostate cancer remains the leading cancer type among men outside of skin cancer, and about one man in every six will develop the illness during his lifetime. Caught early, it is often curable. About 239,000 new cases of prostate cancer are diagnosed among American men each year, and nearly 30,000 men die from the disease annually.

Xofigo is co-marketed in the US by Wayne, N.J.-based Bayer Pharmaceuticals and Algeta US of Cambridge, Mass.

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DNA Test Shows Promise in Guiding Advanced Breast Cancer Care

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Colonoscopy Cuts Advanced Cancer Risk by 70 Percent: Study

By Barbara Bronson Gray

HealthDay Reporter

MONDAY, March 4 (HealthDay News) -- A new study finds that getting screening colonoscopies may reduce the risk of developing advanced colon cancer.

In average-risk people, screening colonoscopies were associated with a 70 percent reduction in risk for new, late-stage colon cancer, including hard-to-detect cancers on the right side of the colon. Advanced colon cancer is the least curable form.

Although colonoscopy is widely used as a screening test for colon cancer, there is little research that proves it is effective in reducing colon cancer deaths, according to the study authors. The researchers wanted to answer a simple question: If you ended up with late-stage cancer, were you more or less likely to have had a screening colonoscopy as many as 10 years before the disease was discovered?

The study authors also wanted to show whether a colonoscopy is able to evaluate the entire colon, including the right side, which is harder to adequately cleanse before the test, more difficult to reach, and often has pre-cancerous areas that are tougher to spot and identify.

"Colonoscopy has the ability to identify both left- and right-sided colon cancers before they have progressed to an advanced stage," said lead study author Dr. Chyke Doubeni, associate professor in the department of family medicine at the University of Pennsylvania.

The researchers also discovered that screening sigmoidoscopy, a less costly procedure that enables a physician to look at the part of the large intestine closest to the rectum, was linked to a significant reduction in late-stage disease in most of the large intestine, but not in the right colon.

However, the study does not show that colonoscopy or sigmoidoscopy is better than the much easier, far less expensive "fecal occult blood test" (FOBT), which is done at home by swiping a tiny amount of stool onto a card for three days, said Doubeni. "There is strong evidence showing the effectiveness of the [fecal occult blood test] when done annually. There is no reason, based on the knowledge we currently have, that you should switch to a colonoscopy if you're getting a FOBT every year," said Doubeni.

If simpler tests are effective, why are patients encouraged to undergo a colonoscopy? "Let me just say there are other factors beyond the evidence that are driving the use of colonoscopy in the U.S.," said Doubeni. "No other country uses colonoscopy for screening purposes as much as the United States, although Germany comes close," he noted.

The U.S. Preventive Services Task Force recommends that people 50 to 75 years old be screened for colon cancer in one of three ways: a home fecal occult blood test every year; a sigmoidoscopy every five years combined with a home fecal occult blood test every three years; or a colonoscopy every 10 years.

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More Younger Women Diagnosed With Advanced Breast Cancer: Study

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New Drug Regimens May Slow Advanced Breast Cancer

Title: New Drug Regimens May Slow Advanced Breast Cancer
Category: Health News
Created: 12/5/2012 10:35:00 AM
Last Editorial Review: 12/5/2012 12:00:00 AM

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