There is probably no other cancer that has seen such breakthroughs in the past five years than kidney cancer. Since the approval of Nexavar (sorafenib) in late 2005, Votrient (pazopanib) is now the sixth drug approved for the cancer. The other targeted drugs approved for kidney cancer are Sutent (sunitinib), Torisel (temsirolimus), Afinitor (everolimus), which was approved in March, and Avastin (bevacizumab), which received approval in August.
The Food and Drug Administration gave the thumbs up to Votrient on October 19, only two weeks after an FDA advisory committee recommended the drug for approval. Votrient, like Nexavar, Sutent, and Avastin, is an antiangiogenic therapy that inhibits the growth of new blood vessels that provide nourishment to the tumor. The advisory committee said side effects were comparable overall, but noted that patients unable to tolerate other approved drugs because of certain side effects, such as fatigue and rash, may have better luck on Votrient. Side effects of Votrient include diarrhea, hypertension, nausea, and a rare, but severe, risk of liver failure.
The drug was approved based on results of a phase 3 study of 435 patients with metastatic renal cell carcinoma who had received either no prior therapy or prior cytokine therapy. The patients on Votrient had better progression-free survival than patients on placebo (9.2 months versus 4.2 months). Newly diagnosed patients who received Votrient as a first-line therapy fared even better (11.1 months versus 2.8 months). A phase 3 clinical trial looking at Votrient versus Sutent, the standard treatment for advanced kidney cancer, in patients with locally advanced or metastatic disease is currently ongoing.
For more information on Votrient, call 888-825-5249 or visit www.votrient.com (site is owned by GlaxoSmithKline).
After three years of being the exclusive cervical cancer vaccine in the U.S., Gardasil now has company. The Food and Drug Administration approved Cervarix on October 16 for females ages 10 to 25 for the prevention of human papillomavirus, the leading cause of cervical cancer.
Cervarix protects against HPV types 16 and 18, the two strains most related to cervical cancer, although there are more than 100 types that have been associated with cervical, anal, and penile cancers, and genital warts. The new vaccine, like Gardasil, is given in three shots over six months. Cervarix has a similar safety profile to Gardasil, with side effects including pain, redness, and swelling at the site of the injection, as well as fatigue, headache, and gastrointestinal symptoms.
Gardasil, which was originally approved in 2006 for females ages 9 to 26 for prevention of cervical cancer, received an additional approval for boys ages 9 to 26 on October 16 as a preventive vaccine against genital warts. Giving the vaccine to boys could also avoid the spread of HPV to female sexual partners and prevent penile and anal cancers in men, although Merck, the maker of Gardasil, currently isn’t seeking approval for those indications.
Although Gardasil is now approved for boys, it is not known whether it’s worth the money. The series of three shots costs about $390. (Cervarix costs about $385.) A recently published U.S. study, which appeared in the online version of the British Medical Journal a week before the FDA made its decision, found that if 75 percent of girls get the vaccine and are protected from cervical cancer, routine vaccination of boys against HPV may not be cost-effective. Researchers noted that although vaccinating girls was very cost-effective, they found that when boys were added to the equation, the benefits did not outweigh the financial costs.
Zevalin (ibritumomab), originally approved by the Food and Drug Administration in 2002 for non-Hodgkin lymphoma patients whose cancer had either progressed or recurred on other therapies, has a new indication for newly diagnosed patients.
The September 3 approval was based on a phase 3 study in which patients whose cancer responded to first-line chemotherapy were given Zevalin. After median follow-up of three and a half years, the group that received Zevalin as part of their first-line treatment had a significantly better median progression-free survival than the control group (38 months compared to 18 months).
Zevalin, an antibody that contains a radioactive molecule, works by delivering a lethal dose of DNA-damaging radiation to cancer cells by targeting the CD20 protein on the cell’s surface. Although very effective, many NHL patients are only offered the drug as a last resort, primarily because of the drug’s cost (up to $30,000 per treatment) and radioactivity (it must be delivered in a hospital under a radiologist’s supervision).
For more on Zevalin, call 866-298-8433 or visit www.zevalin.com (site is owned by Spectrum Pharmaceuticals).
Peripheral T-cell lymphoma, a rare and aggressive type of lymphoma that does not have many treatment options, finally has a designated therapy following the Food and Drug Administration’s accelerated approval of Folotyn (pralatrexate) on September 24.
The drug made waves after results were revealed at last year’s American Society of Hematology meeting of a phase 2 trial of 109 patients showing that the drug resulted in 11 complete responses (disappearance of all signs of cancer), 18 partial responses (disease shrinkage of at least 50 percent), and 23 patients with stable disease (no disease progression). There was no comparison arm because of the relatively low incidence of peripheral T-cell lymphoma and a lack of standard treatments for the disease. Side effects in the trial included severe mucositis and thrombocytopenia.
While progression-free survival and overall survival have not yet been demonstrated in the study, the response was enough for the FDA to give the green light to Folotyn because of PTCL’s aggressive nature and lack of successful treatments. Additional studies of Folotyn are ongoing to further assess clinical benefit for consideration of full FDA approval. The drug’s manufacturer, Allos Therapeutics, has established a patient assistance program to help with reimbursement. Patients can learn more about ASAP (Allos Support for Assisting Patients) by calling 877-272-7102 or visiting www.getASAPinfo.com.
[Editor’s Note: According to the National Cancer Institute, accelerated approval is the short-hand term for the process by which the FDA quickly conducts its review of new treatment applications while also putting new safeguards in place. Accelerated approval is based on surrogate endpoint judgments: the FDA can grant marketing approval to drugs and treatments that, according to certain indicators, prove they are likely to have beneficial effects on a disease or condition, even before such direct benefits have been shown clinically. Accelerated approval does not mean that additional clinical trials are not needed or that the FDA stops gathering information about the effects of the drug; a follow-up study is required to demonstrate activity by more conventional endpoints.]
A new treatment called Istodax (romidepsin) was approved on November 5 for cutaneous T-cell lymphoma patients who have progressed on at least one prior therapy. CTCL, a group of rare non-Hodgkin lymphomas, is often mistaken at first for a rash—the cancer cells affect the skin and can cause itchy, red patches, but can also affect the lymph nodes and blood.
Istodax, a histone deacetylase (HDAC) inhibitor, works by reactivating genes that control normal cell growth and development, but were inappropriately shut down by cancer. The approval was based on two studies that looked at a total of 167 CTCL patients who had one or two prior therapies. Because of the lack of proven treatments for CTCL, the studies did not have a comparison arm.
The overall response rate was about 34 percent, with 6 percent of patients experiencing a complete remission of their cancer. The median length of response was 15 months (range of one month to 20-plus months) in one study and 11 months (range of one month to 66-plus months) in the second. Common side effects of Istodax include nausea, fatigue, infection, and anemia.
For details, call 866-223-7145 or visit www.istodax.com (site is owned by Gloucester Pharmaceuticals).
On October 26, the Food and Drug Administration gave the OK to Arzerra (ofatumumab), a monoclonal antibody that targets the CD20 receptor on chronic lymphocytic leukemia cells. The approval was based on a study in which 42 percent of CLL patients who had progressed on Fludara (fludarabine) and Campath (alemtuzumab) responded to Arzerra, with a median response of 6.5 months.
Because Arzerra was approved under the FDA’s accelerated approval process, which allows early approval of treatments that fill an unmet need for a specific disease, research is still ongoing to look at how well the agent delays progression of the cancer. It is also being studied in non-Hodgkin lymphoma.
Arzerra is administered intravenously once a week for eight weeks, followed by once a month for four months. Common side effects of Arzerra include a decrease in blood counts, pneumonia, fever, and fatigue. The drug’s most serious side effect is an increased risk of infections, including a brain infection called progressive multifocal leukoencephalopathy, which is generally fatal.
For more information, call 888-825-5249 or visit www.arzerra.com (site is owned by GlaxoSmithKline).