WASHINGTON, Jan 28, (Agencies): Patients with hard-to-treat kidney cancer that has spread to other parts of the body gained a new drug option Friday, after US government regulators approved a twice-a-day pill from Pfizer for the disease.
The Food and Drug Administration approved the company’s drug Inlyta as a secondary option for patients with renal cell carcinoma that hasn’t responded to previous drug treatments. Renal cell carcinoma is the most common form of kidney cancer, with an estimated 61,000 people in the US newly diagnosed last year, according to the National Cancer Institute. Only about 11 percent of patients with advanced kidney cancer survive five years or more after diagnosis.
Like other recent cancer drugs, Inlyta works by blocking proteins that promote tumor growth and cancer progression.
The market for kidney cancer drugs has grown increasingly crowded in recent years, with six other new drugs approved in the last six years, including Roche’s Avastin and GlaxoSmithKline’s Votrient. Pfizer’s drug is only the second to be designated as a backup, or second-line, treatment after other kidney cancer drugs have been prescribed. Pfizer is also conducting studies of the drug as a first-line option against kidney cancer.
“This is the seventh drug that has been approved for the treatment of metastatic or advanced kidney cell cancer since 2005,” said Dr Richard Pazdur, FDA’s cancer drug director, in a statement. “Collectively, this unprecedented level of drug development within this time period has significantly altered the treatment paradigm.”
The FDA approved the drug based on a single study in which patients on Inlyta, known chemically as axitinib, experienced two more months without their cancer worsening than patients taking Nexavar, a drug from Bayer and Onyx Pharmaceuticals.

Assisted suicide: A paralyzed British man who wants to die won the first round in his legal battle Friday, when the High Court ruled his lawyers won’t be prosecuted if they seek out experts to help him commit suicide.
The man, who is in his 40s and identified only as Martin, has locked-in syndrome after a stroke and communicates by moving his eyes. He says he wants to end his life, and his lawyers sought a declaration that they could seek information about his options — including Swiss assisted-suicide clinics — to help him prepare a legal challenge.
Under British law, assisting a suicide is punishable by up to 14 years in prison, but convictions are rare. More than 100 Britons have died in clinics run by the Swiss group Dignitas since 1998, and no relative or friend has been charged.
In Martin’s case, lawyers say neither his wife nor any other member of his family is willing to help him die.
Two judges declared Friday that the lawyers could obtain information from experts and “identify one or more people or bodies that might be willing to assist Martin.”
Martin’s lawyers still plan to go to court seeking clarification of guidelines laid out by the country’s chief prosecutor in 2010, which listed mitigating factors, such as compassion, in cases of assisted suicide.
Martin’s lawyers want a declaration that professionals they find to help their client end his life will not face criminal or disciplinary action in doing so.
Rosa Curling, one of Martin’s lawyers, welcomed the ruling.
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Sperm donor: A California man who donates his sperm for free to couples who want to have a baby is being investigated by US regulators but insists he will continue his efforts as a matter of goodwill.
Trent Arsenault, 36, first attracted scrutiny from the US Food and Drug Administration in 2009 for his free sperm donations, which he says resulted in 14 births with several more babies on the way.
A cease-and-desist letter from the FDA in November 2010 did not dissuade him — there have been five pregnancies and one birth since that notice arrived, he told AFP, adding that he still has no hearing date with the regulatory agency.
“I want to continue because the amount of e-mails from childless couples has been tremendous,” Arsenault said. “All of them have similar stories — that it is too costly to conceive via a sperm bank.”
People who purchase from a registered sperm bank typically pay between $200 and $675 per dose, according to Fairfax Cryobank in Virginia.
Arsenault’s personal website, trentdonor.org, describes him as a blond-haired, brown-eyed Silicon Valley tech worker.
His background is half German, one quarter Irish and one quarter French. He learned to play piano by ear by the age of eight, speaks Spanish and English, is “amazed by nature” and studied engineering at the US Naval Academy in Annapolis, Maryland.
He donates his sperm at no cost to “married couples with fertility challenges and female domestic partners,” according to his site which links to a donor agreement that absolves him of responsibility and visitation rights.
His recipients are not named but numerous pictures of babies are posted along with anonymous testimonials such as “advanced for her age,” “healthy... strong,” and “everything I could ever ask for in life.”
The FDA declined to comment because the matter involves an open investigation.
However the agency said in an email to AFP that sperm donations must be screened for a host of sexually-transmitted diseases, including HIV, hepatitis and gonorrhea.
“Under FDA’s regulations, sperm donors are required to be screened for risk factors that may increase the chances of transmitting a communicable disease,” it said. “FDA regulations apply to tissue intended for transplantation only.”
Arsenault has posted online copies of lab results showing he tested negative for HIV, chlamydia, gonorrhea, hepatitis A, B and C, and herpes.
However his sperm samples are labeled: “For immediate transfer to SIP (sexually intimate partner),” “Not evaluated for infectious substances,” and “Warning: advise recipient of communicable disease risks,” his website says.
Arsenault has appealed the FDA’s order on the basis that “he could provide documentation by and testimony from women to whom he had donated.... that he was a sexually intimate partner,” according to legal documents.
In that case, he should be considered “exempt from the regulatory requirements,” his lawyer argued in the documents. Arsenault said he is currently awaiting a response from the FDA.
According to Trina Leonard, a spokeswoman for Fairfax Cryobank in Virginia, people who use his services may be saving a few hundred dollars but are risking a lot.
“There is so much testing and protection involved with donor sperm from a reputable bank that is not in place for people who are using this renegade sperm donor,” she told AFP.
“This is like conceiving a baby with somebody you just met, or unprotected sex on a first date with. It is completely unprotected, unscreened, un-anything-ed. That is just crazy,” she added.
Only one to two percent of all would-be sperm donors are accepted by official sperm banks, and donors tend to be paid $100 to $150 per donation, Leonard said.
As to what motivates Arsenault, his website contains 10 bullet point descriptions including his “spirit of volunteering to the community,” his respect for women, his faith in God, and his rejection of powerful corporations that profit from commercial sperm banks.
“One of Trent’s closest childhood friends was an only child whose parents tried for years to conceive,” it adds.
“Trent knows first-hand the struggle families go through to have a child and he wishes to help.”