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BY LINDSAY RAY | JANUARY 31, 2012
Skin Cancer
Ahead of its March 8 deadline, the Food and Drug Administration (FDA) approved Erivedge (vismodegib, GDC-0449) on Jan. 30 for patients with locally advanced basal cell carcinoma (BCC) that can't be treated with surgery or radiation or who have metastatic BCC, making Erivdege the first drug approved by the FDA for metastatic BCC. In another first, Erivedge is the first drug approved that works by inhibiting the Hedgehog pathway, which is involved in controlling cancer cell division and active in most BCCs. The drug is a pill taken once a day.
BCC, along with squamous cell carcinoma, is a non-melanoma skin cancer and one of the most common types of skin cancer, with an estimated 3.5 million cases diagnosed each year. Advanced BCC is rare, however, and disfiguring, which is why the drug fills an unmet need in this patient population. Last April, we covered some of the research about Erivedge (then known as GDC-0449) and even the first patient to try the drug, which you can read about here.
The approval in based on a multicenter trial with 96 patients. Of those with metastatic BCC, 30 percent had partial tumor shrinkage, and of those with locally advanced BCC, 43 percent had partial or complete tumor shrinkage.
Side effects include nausea, fatigue, hair loss, diarrhea, changes in taste and weight loss. Some serious side effects may occur, so a boxed warning will be included on the drug alerting physicians to potential risk of death or birth defects for an unborn baby. Doctors are required to verify pregnancy status before starting treatment.
A month's supply should cost $7,500, and Genentech (the drug's manufacturer) estimates a treatment course will last 10 months, totaling $75,000. The Patient Action Network Foundation has announced they will now offer co-payment assistance up to $7,500 per year for out-of-pocket expenses. To see the eligibility guidelines and for more information about the program, visit the Patient Action Network Foundation.
This drug should be available in one to two weeks, per the manufacturer.
For more information about Erivedge, visit www.erivedge.com.
Kidney Cancer
Just a few days before, on Jan. 27, the FDA also approved Inlyta (axitinib) for patients with advanced renal cell carcinoma (kidney cancer) who haven't responded to previous treatment.
Inlyta targets the vascular endothelial growth factor (VEGF) pathway, which is important to the development of new blood vessels in tumors, which helps tumors grow. The approval follows a 723-patient trial in which patients on Inlyta had a median progression-free survival of 6.7 months compared with the 4.7 months on the standard treatment, Nexavar (sorafenib).
Inlyta is a pill taken twice daily and is expected to cost around $8,900 per month. Side effects include diarrhea, fatigue, high blood pressure, decreased appetite and nausea. Because it can cause high blood pressure, individuals with this condition should have it controlled before taking Inlyta. Also, sometimes serious bleeding problems can occur, so patients with untreated brain tumors or gastrointestinal bleeding should not take Inlyta.
For more details, visit www.inlyta.com.
Non-Hodgkin Lymphoma
Finally, pixantrone was pulled from the FDA approval pipeline earlier this week. In 2010, the FDA rejected the drug, but Cell Therapeutics (its manufacturer) appealed and resubmitted the drug for approval as a treatment for non-Hodgkin lymphoma patients who no longer responded to other therapies. An FDA advisory meeting was set for Feb. 9, with a possible approval in April, but the manufacturer pulled the application to allow the company more time to prepare for the review. It plans to resubmit later this year.
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the best cancer/infection fiethgr found to date was Interferon. At the time it was $ 15,000 a gram. The paper also said that Interferon was a by-product of the natural breakdown of Vitamin C in your body. Shortly after that the FDA tried to make Vitamin C by prescription only. Guess why? The FDA has the RDA for Vitamin C set at 64 mg a day, just enough to ward off scurvy. Linus Pauling, who got a Nobel Prize for his work with Vitamin C and a second Nobel Prize for Organic Chemistry, said that 1000 mg a day should be the minimum and 2000 mg a day if you are sick or smoke. He played tennis almost daily until the day he died at 96. Personally, I got sick twice a year for 2 weeks at a time, for more than 20 years, with something to this day the doctors have no idea what it was, but for a week in the middle of those 2 weeks I was flat on my back. I started Vitamin C therapy once I gave up on the doctors. I took enough to be asymptomatic for those 2 weeks. Too much and I got diarrhea and too little and I got sick. Within a narrow range, and it followed a bell curve over those 2 weeks, I was not sick. At the height I was taking 40,000 mg a day and 300,000 over the 2 weeks. After 2 years of that I have not been sick since – more than 15 years. Vitamin C acts as a natural diuretic so you need to drink a lot of water and watch your body in total, but my kidneys did not dissolve as the doctors predicted, or get massive kidney stones as other predicted. I did not dissolve my bones as some predicted or completely calcify my joints as others predicted. I had no side effects at all. It might be something to consider.
- Posted by Oso 3/4/12 6:36 PM