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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.
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.
KABUL — Afghan intelligence agents on Sunday gunned down a man in a sport utility vehicle that officials said had been packed with explosives, foiling what they described as an attempt to set off a massive explosion in a neighborhood of narrow streets lined with foreign embassies.
Around the same time, Taliban suicide attackers set off three separate car bombs in a pair of provinces near the capital. But they inflicted minimal damage, according to officials, and the toll from the Sunday violence was low — apart from the two attackers and one suspect killed, two security guards and a police officer were slain and five other people wounded, including one attacker who managed to flee.
Zabiullah Mujahid, a spokesman for the Taliban, said the insurgents were behind the three successful bombings. But he disavowed knowledge of the attempt in Kabul, saying Taliban commanders in the city had no plans to launch an attack on Sunday.
While it is not unusual for the Taliban to deny having a hand in a failed attack, much about the attempted bombing Sunday remained murky, with officials hailing Afghan security forces for acting quickly but offering only the barest details about how the man said to be a bomber was spotted.
Gen. Mohammed Ayoub Salangi, the police chief of Kabul, said the suspect was in a Toyota sport utility vehicle and was trying to pass through a checkpoint when he was recognized by agents from the country’s intelligence service, the National Directorate of Security.
The man “was gunned down,” General Salangi said. The agents had to act quickly, he added, saying that there was no time to inspect the vehicle or question the suspect because that would have given him the chance to detonate the explosives.
General Salangi, who in an earlier statement said there were two men in the car, did not say how or why the agents recognized the man. But he added that the car bomb was quickly defused by experts from the Security Directorate and carted away.
The bombing attempt, in the Wazir Akbar Khan neighborhood, did briefly cause some of the embassies to lock down the streets on which they are located and on which they control security. The spot were the man was shot were was less than a mile from the U.S. Embassy and the headquarters of the American-led coalition, neither of which offered any comment.
Earlier in the day, in Jalalabad, a city in eastern Afghanistan, a single bomber in a Toyota Corolla directly targeted the Security Directorate, officials said, detonating his explosive-laden vehicle outside a building used by the spy agency. Two guards were killed and a third was wounded, said Hazrat Mohammad Mashraqiwal, a police spokesman in Jalalabad.
Later on Sunday, a pair of bombers in another car laden with explosives tried to enter the district governor’s compound in Baraki Barak district of Logar Province, south of Kabul. But they were stopped by police officers guarding the compound, prompting one man to jump and make a run for it and the other to set off the car bomb, said Abdul Rahim Amin, the governor.
One police officer was wounded in the attack, along with the man who fled.
Earlier in Logar, around dawn, a minivan packed with explosives was set off at a police post near the provincial capital, Pul-e-Alam. One police officer was killed and two others wounded, an official said.
Sharifullah Sahak contributed reporting.
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.
KIRKUK, Iraq (Reuters) - Iraqi President Jalal Talabani is now able to talk, his doctor said, adding he was hopeful the Kurdish statesman would soon be fit to return to Iraq from Germany, where he has been receiving medical treatment for a stroke.
A peace-maker who often mediated among Iraq's Shi'ite, Sunni and Kurdish factions, 79-year-old Talabani was flown abroad in December in critical condition.
"I am in continuous contact with the German team treating President Talabani," said Najmaldin Karim, who is also governor of the city of Kirkuk.
"He can talk now with the people around him and started to think in a good way. I and the German team are optimistic that he will get much better and can return back to Iraq soon."
During Talabani's absence, Iraq's political crisis has intensified, with thousands of Sunni Muslims taking to the streets in protest against the Shi'ite-led government
The veteran politician often worked to ease tensions in the country's fragile power-sharing government and negotiated between Baghdad and the autonomous Kurdistan region, which are locked in feud over land and oil rights.
(Writing by Isabel Coles; Editing by Nick Macfie)
02/22/2013 at 01:00 PM ET
Denise Truscello/Wireimage
Mario Lopez is a man of his word.
Following a December wedding, the EXTRA host declared he and wife Courtney would get to work expanding their family immediately — and he wasn’t kidding.
In January, the couple discovered they were indeed expecting.
“Mario and I are so excited to add to our family! I found out a month ago and surprised Mario with the good news at breakfast,” Courtney tells PEOPLE.
But the proud parents aren’t the only ones gearing up for a new addition. Big sister Gia Francesca, 2, already has babies on the brain.
“Gia kind of understands that there is a baby in my belly,” Courtney notes. “She also told me our dog Julio has a baby in his belly — so who knows!”
Despite a bumpy start — “I had a rough couple of weeks when I first found out,” she shares — the mom-to-be is feeling better and already sporting quite the blossoming belly. “I am showing so much faster this time around,” she says.
And with warmer weather on the way, Courtney will be swathing her bump in floor-length frocks — but plans on forgoing a few fashion ensembles from her past.
“I love being pregnant in the summer! I live in maxi dresses,” she says. “Looking back at my first pregnancy, there are certain things that I wore and I have no idea why. I looked horrible and I won’t do that again!”
Originally from Pittsburgh, the expectant mama is thrilled to have settled down with her growing family on the West Coast. Her only wish? That her children will one day enjoy a winter wonderland.
“I don’t miss the East Coast at all — especially the humidity,” she explains. “The one thing I do want my children to experience from an early age is snow. There is nothing like being a kid playing in the snow.”
– Anya Leon
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.
Los Angeles County's venture into toll roads advanced early Saturday with the opening of 14 miles of express lanes on the San Bernardino Freeway — the second project of its type to begin operation in the region since November.
At 12:01 a.m., the Los Angeles County Metropolitan Transportation Authority allowed drivers to travel the 10 Freeway's new high occupancy toll lanes — so-called HOT lanes — between Interstate 605 in El Monte and Alameda Street in downtown Los Angeles.
"This shows we are willing to address traffic, gridlock and congestion in the region," said Los Angeles Mayor and MTA board member Antonio Villaraigosa at a dedication ceremony in El Monte on Friday. "Other cities are going to do this across the county. We are going to see smarter use of highways."
The two westbound and two eastbound "Metro ExpressLanes" will be open to solo motorists who pay a toll, but they will be free for cars carrying at least two passengers.
During peak travel times, however, only carpools of three or more people will be able to use the lanes without paying. Van pools and motorcyclists also can enter the lanes toll free.
Using congestion pricing, motorists will pay anywhere from $0.25 a mile during off-peak periods to $1.40 a mile during the height of rush hour. MTA officials estimate that the average one-way cost should range between $4 and $7.
Setting tolls based on the volume of traffic is designed to maintain speeds of no less than 45 mph in the lanes. If the speed falls below that level, solo motorists will be prohibited from entering the lanes until the minimum speed resumes.
Motorists interested in the express lanes must open a FasTrak account with the MTA and make a $40 deposit to obtain a transponder, an electronic device that automatically bills their accounts whenever the lanes are used. Drivers can adjust the transponder to show how many people are in the vehicle, so the charges can be adjusted. Information is available online at metroexpresslanes.net.
The county marked its entry into the use of tollways on Nov. 10, when the MTA opened its first express lanes along 11 miles of the Harbor Freeway between Adams Boulevard in Los Angeles and the Harbor Gateway Transit Center in the South Bay.
The lanes on both freeways are part of a $210-million demonstration project funded largely by the federal government. It includes upgrading transit and rail stations, 59 new clean-fuel buses, the $60-million El Monte Bus Station, highway ramp improvements and 100 new vanpools.
MTA officials said the express lanes on the 10 and 110 will cost $7 million to $10 million a year to operate, but should generate $18 million to $20 million in revenue, money that can be reinvested in both freeway corridors. So far, more than 100,000 people have obtained transponders for the lanes, officials said.
During the next year, the express-lane projects will be evaluated to determine whether the program should be continued and expanded to other freeways in the county.
"We expect it will be totally successful," said Victor Mendez, head of the Federal Highway Administration. "The project offers commuters a variety of choices, not just the highway."
dan.weikel@latimes.com
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