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Updated: Monday Feb 25, 2013 | 01:30 PM EST
WASHINGTON (AP) — The Food and Drug Administration has approved a first-of-a-kind breast cancer medication that targets tumor cells while sparing healthy ones.
The drug Kadcyla from Roche combines the established drug Herceptin with a powerful chemotherapy drug and a third chemical linking the medicines together. The chemical keeps the cocktail intact until it binds to a cancer cell, delivering a potent dose of anti-tumor poison.
Cancer researchers say the drug is an important step forward because it delivers more medication while reducing the unpleasant side effects of chemotherapy.
"This antibody goes seeking out the tumor cells, gets internalized and then explodes them from within. So it's very kind and gentle on the patients — there's no hair loss, no nausea, no vomiting," said Dr. Melody Cobleigh of Rush University Medical Center. "It's a revolutionary way of treating cancer."
Cobleigh helped conduct the key studies of the drug at the Chicago facility.
The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy. These patients have tumors that overproduce a protein known as HER-2. Breast cancer is the second most deadly form of cancer in U.S. women, and is expected to kill more than 39,000 Americans this year, according to the National Cancer Institute.
The approval will help Roche's Genentech unit build on the blockbuster success of Herceptin, which has long dominated the breast cancer marketplace. The drug had sales of roughly $6 billion last year.
Genentech said Friday that Kadcyla will cost $9,800 per month, compared to $4,500 per month for regular Herceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.
FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.
Overall, patients taking Kadcyla lived about 2.6 years, compared with 2 years for patients taking the other drugs.
FDA specifically approved the drug for patients with advanced breast cancer who have already been treated with Herceptin and taxane, a widely used chemotherapy drug. Doctors are not required to follow FDA prescribing guidelines, and cancer researchers say the drug could have great potential in patients with earlier forms of breast cancer
Kadcyla will carry a boxed warning, the most severe type, alerting doctors and patients that the drug can cause liver toxicity, heart problems and potentially death. The drug can also cause severe birth defects and should not be used by pregnant women.
Kadcyla was developed by South San Francisco-based Genentech using drug-binding technology licensed from Waltham, Mass.-based ImmunoGen. The company developed the chemical that keeps the drug cocktail together and is scheduled to receive a $10.5 million payment from Genentech on the FDA decision. The company will also receive additional royalties on the drug's sales.
Shares of ImmunoGen Inc. rose 2 cents to $14.32 in afternoon trading. The stock has ttraded in a 52-wek range of $10.85 to $18.10.
A "relatively unflappable" Cardinal Roger Mahony answered questions under oath for more than 3 1/2 hours Saturday about his handling of clergy sex abuse cases, according to the lawyer who questioned the former archbishop.
"He remained calm and seemingly collected at all times," said attorney Anthony De Marco, who represents a man suing the Los Angeles Archdiocese over abuse he alleges he suffered at the hands of a priest who visited his parish in 1987.
Mahony has been deposed many times in the past, but Saturday's session was the first time he had been asked about recently released internal church records that show he shielded abusers from law enforcement.
De Marco declined to detail the questions he asked or the answers the cardinal provided, citing a judge's protective order.
The deposition occurred just before Mahony was to board a plane for Italy to vote in the conclave that will elect the next pope. In a Twitter post Friday, Mahony wrote that it was "just a few short hours before my departure for Rome."
Church officials did not return requests for comment.
The case, set for trial in April, concerns a Mexican priest, Nicholas Aguilar Rivera. Authorities believe he molested at least 26 children during a nine-month stay in Los Angeles.
Recently released church files show Aguilar Rivera fled to Mexico after a top Mahony aide, Thomas Curry, warned him that parents were likely to go the police and that he was in "a good deal of danger." Aguilar Rivera remains a fugitive in Mexico.
The archdiocese had agreed that Mahony could be questioned for four hours about the Aguilar Rivera case and 25 other priests accused in the same period. De Marco said he did not get to ask everything he wanted and would seek additional time after the cardinal returned from the Vatican.
Past depositions of Mahony have eventually become public, and De Marco said he would follow court procedures to seek the release of a transcript of Saturday's deposition.
Meanwhile, a Catholic organization Saturday delivered a petition with thousands of signatures asking that Mahony recuse himself from the conclave in Rome.
The group, Catholics United, collected nearly 10,000 signatures making "a simple request" that the former archbishop of Los Angeles not participate in the process because of the priest abuse scandals that happened under his watch, said Chris Pumpelly, communications director for Catholics United.
The petition was delivered Saturday to St. Charles Borromeo in North Hollywood, where the cardinal resides. It was accepted by a church staff member.
After delivering the petition, organizers attended Mass at the parish to pray for healing and for the future of the church.
harriet.ryan@latimes.com
Times staff writer Rick Rojas contributed to this report.
Andrew Medichini/Associated Press
Pope Benedict XVI delivered his final Sunday address from the window of his apartment overlooking St. Peter's Square.
VATICAN CITY — In his last Sunday blessing before he retires, Pope Benedict XVI reassured Catholics that he was not abandoning them but would continue to serve the church even in his retirement.
Romans, pilgrims and curious tourists filled St. Peter’s Square on Sunday for Benedict’s second-to-last public appearance before he steps down on Thursday, the first pope in six centuries to do so willingly.
Reading from prepared remarks as he stood at the window of the Apostolic Palace, Benedict that said he was being called by God “to climb up on the mountain” and to dedicate himself more to “prayer and meditation.”
“This doesn’t mean abandoning the church,” the pope added, to the applause of the crowd. “On the contrary, if God asks me, this is because I can continue to serve” the church “with the same dedication and the same love which I have tried to do so until now, but in a way more suitable to my age and to my strength.”
Cardinals from around the world have begun gathering in Rome to greet Benedict before he retires at 8 p.m. on Thursday. At that point, the cardinals will meet to discuss when to begin the conclave to elect his successor.
One member of the crowd in St. Peter’s Square on Sunday, Jan Cartwright, 61, said she had traveled to Rome from Wales. “We’ve come for the rugby, but we’re Catholic, and it is history, isn’t it,” she said.
Ms. Cartwright said she was surprised that the pope had decided to resign. “We have the queen,” she said. “No one in the royal family would step down, they just go on until they die, really.” But she said she admired Benedict’s decision. “I think it’s a brave thing to do,” she said. “He’s an old man.”
Maria Concetta Campanella from Rome was also in the crowd. “It’s a historic moment,” she said. “It teaches us humility. He teaches us that we can’t sit in our chairs forever, that when the time is right, we have to leave the chair.”
Vito Ugo, an Augustinian monk holding a Brazilian flag, was taking pictures with two of his fellow monks, all dressed in long black robes. “We feel great emotion to be here,” he said.
Asked whether he hoped the cardinals would elect a South American pope in the conclave, Brother Ugo smiled. “It’s what God wants,” he said humbly.
From left: Bradley Cooper, Oscar, Jessica Chastain
AFP/Getty; Wireimage; Splash News Online
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WASHINGTON (AP) — The Food and Drug Administration has approved a first-of-a-kind breast cancer medication that targets tumor cells while sparing healthy ones.
The drug Kadcyla from Roche combines the established drug Herceptin with a powerful chemotherapy drug and a third chemical linking the medicines together. The chemical keeps the cocktail intact until it binds to a cancer cell, delivering a potent dose of anti-tumor poison.
Cancer researchers say the drug is an important step forward because it delivers more medication while reducing the unpleasant side effects of chemotherapy.
"This antibody goes seeking out the tumor cells, gets internalized and then explodes them from within. So it's very kind and gentle on the patients — there's no hair loss, no nausea, no vomiting," said Dr. Melody Cobleigh of Rush University Medical Center. "It's a revolutionary way of treating cancer."
Cobleigh helped conduct the key studies of the drug at the Chicago facility.
The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy. These patients have tumors that overproduce a protein known as HER-2. Breast cancer is the second most deadly form of cancer in U.S. women, and is expected to kill more than 39,000 Americans this year, according to the National Cancer Institute.
The approval will help Roche's Genentech unit build on the blockbuster success of Herceptin, which has long dominated the breast cancer marketplace. The drug had sales of roughly $6 billion last year.
Genentech said Friday that Kadcyla will cost $9,800 per month, compared to $4,500 per month for regular Herceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.
FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.
Overall, patients taking Kadcyla lived about 2.6 years, compared with 2 years for patients taking the other drugs.
FDA specifically approved the drug for patients with advanced breast cancer who have already been treated with Herceptin and taxane, a widely used chemotherapy drug. Doctors are not required to follow FDA prescribing guidelines, and cancer researchers say the drug could have great potential in patients with earlier forms of breast cancer
Kadcyla will carry a boxed warning, the most severe type, alerting doctors and patients that the drug can cause liver toxicity, heart problems and potentially death. The drug can also cause severe birth defects and should not be used by pregnant women.
Kadcyla was developed by South San Francisco-based Genentech using drug-binding technology licensed from Waltham, Mass.-based ImmunoGen. The company developed the chemical that keeps the drug cocktail together and is scheduled to receive a $10.5 million payment from Genentech on the FDA decision. The company will also receive additional royalties on the drug's sales.
Shares of ImmunoGen Inc. rose 2 cents to $14.32 in afternoon trading. The stock has ttraded in a 52-wek range of $10.85 to $18.10.
SACRAMENTO — Thousands of paroled child molesters, rapists and other high-risk sex offenders in California are removing or disarming their court-ordered GPS tracking devices — and some have been charged with new crimes including sexual battery, kidnapping and attempted manslaughter.
The offenders have discovered that they can disable the monitors, often with little risk of serving time for it, a Times investigation has found. The jails are too full to hold them.
"It's a huge problem," said Fresno parole agent Matt Hill. "If the public knew, they'd be shocked."
More than 3,400 arrest warrants for GPS tamperers have been issued since October 2011, when the state began referring parole violators to county jails instead of returning them to its packed prisons. Warrants increased 28% in 2012 compared to the 12 months before the change in custody began. Nearly all of the warrants were for sex offenders, who are the vast majority of convicts with monitors, and many were for repeat violations.
The custody shift is part of Gov. Jerry Brown and the legislature's "realignment" program, to comply with court orders to reduce overcrowding in state prisons. But many counties have been under their own court orders to ease crowding in their jails.
Some have freed parole violators within days, or even hours, of arrest rather than keep them in custody. Some have refused to accept them at all.
Before prison realignment took effect, sex offenders who breached parole remained behind bars, awaiting hearings that could send them back to prison for up to a year. Now, the maximum penalty is 180 days in jail, but many never serve that time.
With so little deterrent, parolees "certainly are feeling more bold," said Jack Wallace, an executive at the California Sex Offender Management Board.
Rithy Mam, a convicted child stalker, was arrested three times in two months after skipping parole and was freed almost immediately each time. After his third release, his GPS alarm went off and he vanished, law enforcement records show.
The next day, he turned up in a Stockton living room where a 15-year-old girl was asleep on the couch, police said. The girl told police she awoke to find the stranger staring at her and that he asked "Wanna date?" before leaving the home.
Police say Mam went back twice more that week and menaced the girl and her 13-year-old sister, getting in by giving candy to a toddler, before authorities recaptured him in a local park. He is in custody on new charges of child molestation.
Californians voted in 2006 to require that high-risk sex offenders be tracked for life with GPS monitors strapped to their bodies.
The devices are programmed to record offenders' movements and are intended, at least in part, to deter them from committing crimes. The devices, attached to rubber ankle straps embedded with fiber-optic cable, transmit signals monitored by a private contractor.
They are easy to cut off, but an alarm is triggered when that happens, as it is when they are interfered with in other ways or go dead, or when an offender enters a forbidden area such as a school zone or playground. The monitoring company alerts parole agents by text message or email.
Arrest warrants for GPS tamperers are automatically published online. The Times reviewed that data as well as thousands of jail logs, court documents and criminal histories provided by confidential sources. The records show that the way authorities handle violators can vary significantly by county.
San Bernardino County releases more inmates early from its cramped jails than any other county in California, according to state reports. But sex offenders who violate parole there generally serve their terms. A spokeswoman said the county closely reviews criminal histories, and those with past sex offenses are ineligible for early release.
By contrast, parole violators in San Joaquin County are often set free within a day of arrest.
A review of the county's jail logs shows that nine of the 15 sex offenders arrested for violating parole in December and January were let out within 24 hours, including seven who immediately tampered with their trackers and disappeared. One of the nine, a convicted rapist named Robert Stone, was arrested two weeks later on kidnapping charges and returned to jail, where he remains.
Raoul Leyva, a sex offender with a history of beating women, was arrested in April for fleeing parole and ordered to remain jailed for 100 days. He was out in 16 days and soon bolted again, after allowing the battery on his device to go dead, according to the documents reviewed by The Times.
Less than two weeks later, a drug dealer led police to a Stockton apartment where Leyva's girlfriend, 20-year-old Brandy Arreola, had lain for days on the floor, severely beaten and in a coma. Now brain damaged and confined to a wheelchair, Arreola spends her time watching cartoons.
DUBAI, United Arab Emirates (Reuters) — Days before resuming talks over its disputed nuclear program, Iran said Saturday that it had found significant new deposits of raw uranium and identified sites for 16 more nuclear power stations.
The state news agency IRNA quoted a report by the Atomic Energy Organization of Iran, which said that the reserves were discovered in northern and southern coastal areas and had tripled the amount outlined in previous estimates.
There was no independent confirmation. Western experts had previously thought that Iran, with few uranium mines of its own, might be close to exhausting its supply of raw uranium.
“We have discovered new sources of uranium in the country, and we will put them to use in the near future,” Fereydoun Abbasi-Davani, head of the Atomic Energy Organization, was quoted as saying at Iran’s annual nuclear industry conference.
The timing of the announcement suggested that Iran, by talking up its reserves and nuclear ambitions, may hope to strengthen its negotiating hand at talks in Kazakhstan on Tuesday with the United States, Russia, China, Britain, France and Germany.
Diplomats say the six powers are willing to offer Iran some relief from international sanctions if it agrees to curb its production of higher-grade enriched uranium.
The West says Iran’s enrichment of uranium to a purity of 20 percent demonstrates its intent to develop a nuclear weapons ability, an allegation the Islamic republic denies.
The enriched uranium required for use in nuclear reactors or weapons is produced in centrifuges that spin uranium hexafluoride gas at high speeds. The gas is derived from yellow cake, a concentrate from uranium ore found in mines.
Iran’s raw uranium reserves now total around 4,400 tons, including discoveries over the past 18 months, IRNA quoted the report as saying.
In another sign that Iran is intent on pushing forward with its nuclear ambitions, the report also said that 16 sites had been identified for the construction of nuclear power stations. It did not specify the exact locations but said they included coastal areas of the Persian Gulf, the Gulf of Oman, Khuzestan Province and the Caspian Sea.
The Iranian authorities have long announced their desire to build more nuclear power plants for electricity production. Only one currently exists, in the southern city of Bushehr, and it has suffered several shutdowns in recent months.
The announcements could further complicate the search for a breakthrough in Kazakhstan, after three unsuccessful rounds of talks between the sides in 2012.
“We are meeting all of our obligations under the Nuclear Nonproliferation Treaty, and we should be able to benefit from our rights,” Saeed Jalili, Iran’s chief nuclear negotiator, was quoted as saying at the conference on Saturday. “We don’t accept more responsibilities and less rights.”
In what Washington has called a provocative move, Iran is also installing new-generation centrifuges, capable of producing enriched uranium much faster, at a site in Natanz in the center of the country.
Western diplomats say the six powers will reiterate demands for the suspension of uranium enrichment to a purity of 20 percent, the closing of Iran’s Fordo enrichment plant, increased access for International Atomic Energy Agency inspectors and an agreement to address concerns on existing uranium stockpiles.
In return, the latest embargoes on gold and metals trading with Iran would be lifted. Iran has criticized the offer and says its rights need to be fully recognized.
If the West wants to start constructive talks with Tehran, “It needs to present a valid proposal,” Mr. Jalili said. In a statement issued before the Iranian announcement, the German foreign minister, Guido Westerwelle, said the six-power group wanted to enter a “substantial negotiation process” over Tehran’s nuclear program.
The talks in Kazakhstan “are a chance which I hope Iran takes,” he said.
From your love of a new photos of Beyoncé's growing daughter Blue Ivy to your sadness over the suicide of country star Mindy McCready, readers responded to what made them mad, sad and also what kept them laughing out loud.
Check out the articles with the top reactions on the site this week, and keep clicking on the emoticons at the bottom of every story to tell us what you think!
There is no doubt the baby Blue Ivy is a Daddy's girl as new snaps of the child and her mother Beyoncé revealed this week. While her famous parents have kept her out of the spotlight, a photo of Blue Ivy, now 1, was apparently leaked from Beyoncé's HBO documentary, showing mom and daughter sharing the same photogenic smile.
Meanwhile, seeing Taylor Swift in a very Beyoncé-esque costume at the Brit Awards drew some amusement from readers who wondered if Sasha Fierce now has a pop-country cousin.
Chaz Bono has quickly followed through on his goal to lose significant weight, and readers were wowed by inspirational photos that saw him significantly trimmer and 43 pounds lighter. "I've been sticking to a really strict diet," he tells PEOPLE. "It's not any type of starvation thing. I'm just cutting out a lot of stuff and eating primarily protein and vegetables and fruit."
Readers told us they were angered by Kim Kardashian's maternity style as she continues her habit of wearing tight-fitting fashion, even as her pregnancy has moved into its second trimester. Mom-to-be Kardashian, 32, defended her hourglass shape and its limitations with clothes. "I think because I have big boobs it could make me look heavier if I don't, like, show off my waist or something," she told Du Jour magazine.
Country singer Mindy McCready's tragic suicide at 37 saddened readers. After years of dealing with addiction and legal problems, McCready killed herself at her Arkansas home, leaving behind son Zander, 6, with her ex Billy McKnight, and son Zayne, just 10 months.
Check back next week for another must-read roundup, and see what readers are reacting to every day here.
Taylor Swift at the Brit Awards (right) and Beyoncé at the Super Bowl
Getty; PictureGroup
WASHINGTON (AP) — The Food and Drug Administration has approved a first-of-a-kind breast cancer medication that targets tumor cells while sparing healthy ones.
The drug Kadcyla from Roche combines the established drug Herceptin with a powerful chemotherapy drug and a third chemical linking the medicines together. The chemical keeps the cocktail intact until it binds to a cancer cell, delivering a potent dose of anti-tumor poison.
Cancer researchers say the drug is an important step forward because it delivers more medication while reducing the unpleasant side effects of chemotherapy.
"This antibody goes seeking out the tumor cells, gets internalized and then explodes them from within. So it's very kind and gentle on the patients — there's no hair loss, no nausea, no vomiting," said Dr. Melody Cobleigh of Rush University Medical Center. "It's a revolutionary way of treating cancer."
Cobleigh helped conduct the key studies of the drug at the Chicago facility.
The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy. These patients have tumors that overproduce a protein known as HER-2. Breast cancer is the second most deadly form of cancer in U.S. women, and is expected to kill more than 39,000 Americans this year, according to the National Cancer Institute.
The approval will help Roche's Genentech unit build on the blockbuster success of Herceptin, which has long dominated the breast cancer marketplace. The drug had sales of roughly $6 billion last year.
Genentech said Friday that Kadcyla will cost $9,800 per month, compared to $4,500 per month for regular Herceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.
FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.
Overall, patients taking Kadcyla lived about 2.6 years, compared with 2 years for patients taking the other drugs.
FDA specifically approved the drug for patients with advanced breast cancer who have already been treated with Herceptin and taxane, a widely used chemotherapy drug. Doctors are not required to follow FDA prescribing guidelines, and cancer researchers say the drug could have great potential in patients with earlier forms of breast cancer
Kadcyla will carry a boxed warning, the most severe type, alerting doctors and patients that the drug can cause liver toxicity, heart problems and potentially death. The drug can also cause severe birth defects and should not be used by pregnant women.
Kadcyla was developed by South San Francisco-based Genentech using drug-binding technology licensed from Waltham, Mass.-based ImmunoGen. The company developed the chemical that keeps the drug cocktail together and is scheduled to receive a $10.5 million payment from Genentech on the FDA decision. The company will also receive additional royalties on the drug's sales.
Shares of ImmunoGen Inc. rose 2 cents to $14.32 in afternoon trading. The stock has ttraded in a 52-wek range of $10.85 to $18.10.
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