J&J, Takeda recall batches of cancer drug Velcade
The particles were found in batches of the drug distributed between January and June of this year.
They have been identified as a polyester-like material related to a component of the manufacturing process performed by a contract manufacturer for Millennium, which is now a unit of Japan’s Takeda Pharmaceutical Co.
Velcade, known chemically as bortezomib, is approved to treat multiple myeloma and relapsed mantle cell lymphoma. It is sold by Millennium in the United States and by J&J unit Janssen-Cilag in Europe and the rest of the world.
The recall was the latest to hit J&J, which has been plagued by massive recalls of numerous consumer products, such as Children’s Tylenol and Motrin, keeping those medicines off pharmacy shelves for months.
Six lots of Velcade were voluntarily recalled in Europe and Japan following five reports of floating particles in samples from two of the recalled batches after the powder form of the drug was reconstituted, according to details listed on the U.K. Medicines and Healthcare Regulatory Agency drug alert website (link.reuters.com/tar26q)
Another seven lots are being recalled in the United States as a precaution, Millennium said.
“In the U.S. we have received no confirmed product complaints or adverse events related to this issue,” Millennium spokeswoman Manisha Pai said.
In Europe, the recalled lots originally included about 195,000 vials of the 3.5 milligram dose of Velcade, but J&J expects to see only a fraction of that returned.
“Based on what we know, the majority of the lots has already been consumed. We anticipate recapturing about 20,000 vials,” J&J spokeswoman Kellie McLaughlin said.
The situation is similar in the United States, with Millennium expecting about 10,000 vials to be returned from about 200,000 produced in the seven lots, as most of the drug has already been administered to patients, Pai said.
In addition, 22,300 3-mg vials, only sold in Japan, are being recalled, J&J said.
No injuries were reported and no new safety issues were identified related to the J&J recall, McLaughlin said.
The root cause of the problem has been identified and both companies said all of the recalled lots were produced prior to manufacturing process improvements that were put in place in September of 2009.
South Dakota Smokeout
Two weeks ago, voters in South Dakota passed a smoking ban, eliminating the habit in most restaurants, bars and casinos in the state. This week, The American Cancer Society is promoting the”Great American Smokeout.” Tonight we find out how high schoolers are now joining the cause to help put out cigarettes. It’s the day for all smokers to quit, even if it’s just for a day.
“Put those cigarettes down, don’t take a cigarette and if you can quit smoking for one day, we know you can continue that habit and not smoke,” said Denise Kolba, The American Cancer Society.
The American Cancer Society’s “Great American Smokeout” has been an annual event since 1977.
“Smoking remains the most preventable cause of cancer and we know that we can prevent over 450,000 deaths each year if we can encourage people to quit smoking,” said Kolba.
And now the American Cancer Society is getting help from a surprising place, the halls of O’Gorman High School.
“We’ve heard it since kindergarten how smoking affects you both in health wise and relationships and everything. So we’ve come to that point when we realized smoking is just something we’re not going to get involved with,” said Shilpa Chandran, Senior O’Gorman High School.
Shilpa Chandran is one of many high school students in the group Teens Against Tobacco, also known as TATU.
“High Schoolers are so vulnerable to the ads and campaigns that the tobacco companies put out that it’s probably best for us at this point in our lives to know about this information and hopefully we won’t do it in the future,” said Shilpa Chandran.
“One of the big things the kids at O’Gorman High School are doing to help people quit smoking is offering these Quit Kits. Inside smokers will find plenty of information to help them quit smoking, as well as snacks to keep their minds off of using tobacco.”
And when O’Gorman teacher Ed Whiting heard about these kits, he knew he had to get one.
“I thought it was a perfect fit for my dad. Just take his mind off of smoking alittle bit and remind him we would all like him to live a healthier lifestyle,” sad Ed Whiting, Teacher.
Mr. Whiting appreciates the help from the students, especially since his dad has been smoking since he was 13 years old.
“I think it’s important because it will lead to a healthier lifestyle. I have three young children and we often joke with him that they would like him to show up to their weddings and graduations,” said Whiting.
So now organizers are hoping the smoking ban in South Dakota will provide that little extra motivation to get smokers to quit.
“It is a good opportunity. People are not going to be able to smoke as much and I know they’re going to want and try to stop smoking and by having someone there to help them is the best way to promote it,” said Sabrina Raugutt, TATU Advisor and Teacher.
Exelixis Shares Soar on Cancer Results
Exelixis (NASDAQ: EXEL), the South San Francisco-based developer of cancer drugs, saw its shares climb 32 percent to $6.23 today after reporting on clinical trial results for its lead product candidate against prostate cancer. The company reported that 19 out of 20 patients who got its experimental XL184 treatment had at least partial clearance of lesions on their bones where the cancer had spread. The findings were released at the EORTC-NCI-AACR meeting in Berlin, Germany. Xconomy reported on what this clinical trial data means to Exelixis in an in-depth feature story last month.
