Tag Archives: FDA

Highlights from MBCN’s 2012 Chicago Conference on Metastatic Breast Cancer

Canadian friends Penny Overes, Catherine Spencer and
Danielle Smith were among the 200+ attendees. Alberta represent!

MBCN’s 6th Annual National Conference (“Moving Forward With Metastatic Breast Cancer,”) took place Oct. 13, 2012 at Northwestern’s Lurie Cancer Center in Chicago. In a few weeks, videos and presentation handouts will be posted at MBCN.org. In the interim, here are some highlights from selected breakout sessions, from attendee Pam Breakey. Pam is a long-time participant on the BC.Mets.org site and, as you will see, takes wonderful notes.
Part One: General Sessions

Part Two: Selected Breakout Sessions

We were honored to have Medical Lessons blogger and Atlantic correspondent  Elaine Schattner join us. Dr. Schattner is a trained oncol­ogist, hema­tol­ogist, medical edu­cator and jour­nalist who writes and speaks on med­icine. Her views on health care are informed by her expe­ri­ences as a patient with sco­l­iosis since childhood and other con­di­tions including breast cancer. Her work has appeared in Slate, the New York Times, Sci­en­tific American, Cure Mag­azine and the New York Observer. Read  her great article for the Atlantic here.

MBCN Honors Dr. Pat Steeg’s Dedication to Metastatic Research With the Ellen Moskowitz and Suzanne Hebert Leadership Grant Award

MBCN board member Shirley Mertz presented the award to Dr. Pat Steeg.

In other conference news, MBCN presented Dr. Patricia Steeg with the Ellen Moskowitz and Suzanne Hebert Leadership Grant Award. “For the last 20 years, in her laboratory at the National Cancer Institute, in Bethesda, Maryland, Dr. Patricia Steeg has been researching how cancer cells from the primary tumor in the breast travel to vital organs, in particular the brain,” said Shirley Mertz, MBCN board member and prominent patient advocate. “Dr. Steeg identified the first cancer suppressor gene and has done pioneering work on brain metastasis. Although metastatic research is difficult and involves long and complex experiments, Dr. Steeg remains undeterred. She exerts strong leadership in the research community nationally and internationally.”

Prior to accepting the award, Steeg gave a presentation on “Research on Treatment to Contain Metastatic Growth.” The researcher made a case for redesigning clinical trials to do what she termed “phase II randomized metastasis-prevention trials.” Currently, phase I and phase II clinical trials are done in patients with advanced, refractory metastatic cancer, patients who have had many therapies. In phase II trials,
researchers typically are trying to determine if a drug shrinks metastases.
“But a drug that prevents metastasis may not shrink a large, refractory tumor,” said Steeg. “It has a different mechanism of action that is not picked up by the clinical trial system.” Steeg referenced a
perspective piece, “The Right Trials,” she wrote for Nature this past May.

“The proposal I’ve put forth should apply to a number of different cancers, particularly those where the majority of patients are diagnosed before they have full-blown metastatic disease, or if they have limited, treatable metastatic disease,” Steeg told NCI Cancer Bulletin this past June. “One could imagine applying this to prostate, bladder, and colon cancers.”

Don’t Miss These Awesome Photos:

But wait! There’s more! Awesome conference photographs, courtesy of Ellen Averick Schor are Here.

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NCI’s Pat Steeg: Let’s Redesign Clinical Trials to Test Therapies That Prevent Metastasis

More than 200 people with metastatic breast cancer and their supporters came to Chicago for the 2012 National Metastatic Breast Cancer Conference held on Oct. 13th, National Metastatic Breast Cancer Awareness Day. Photo credit: Ellen Schor

As hundreds of metastatic breast cancer patients offered a standing ovation, the Metastatic Breast Cancer Network (MBCN) presented Dr. Patricia Steeg with the Ellen Moskowitz and Suzanne Hebert Leadership Grant Award. The award was given at MBCN’s 6th Annual National Conference which took place Oct. 13, 2012 at Northwestern’s Lurie Cancer Center in Chicago.

“For the last 20 years, in her laboratory at the National Cancer Institute, in Bethesda, Maryland, Dr. Patricia Steeg has been researching how cancer cells from the primary tumor in the breast travel to vital organs, in particular the brain,” said Shirley Mertz, MBCN board member and prominent patient advocate. “Dr. Steeg identified the first cancer suppressor gene and has done pioneering work on brain metastasis. Although metastatic research is difficult and involves long and complex experiments, Dr. Steeg remains undeterred. She exerts strong leadership in the research community nationally and internationally.”

 

Shirley Mertz with NCI’s Pat Steeg

The award—which includes a monetary grant to be used for metastatic research—is named after MBCN’s former President, Ellen Moskowitz, and former Vice-President, Suzanne Hebert.  “Ellen and Suzanne worked side by side for five years to establish MBCN as the voice of people living with metastatic breast cancer,” said Mertz. “Together, they pushed for change and inspired many to take action to promote awareness and provide education for metastatic breast cancer patients and professionals alike.”

The MBCN board wanted to honor these remarkable women by recognizing a scientist and researcher whose persistent leadership and work embodies what Ellen and Suzanne fought for—research about metastatic disease that could result in treatments to extend the lives of metastatic breast cancer patients.

Mertz presented the award to Steeg “with great appreciation and anticipation for the future…along with our deep thanks for your dedication and persistence in metastasis research.”

Prior to accepting the award, Steeg gave a presentation on “Research on Treatment to Contain Metastatic Growth.” The researcher made a case for redesigning clinical trials to do what she termed “phase II randomized metastasis-prevention trials.” Currently, phase I and phase II clinical trials are done in patients with advanced, refractory metastatic cancer, patients who have had many therapies. In phase II trials, researchers typically are trying to determine if a drug shrinks metastases.

“But a drug that prevents metastasis may not shrink a large, refractory tumor,” said Steeg. “It has a different mechanism of action that is not picked up by the clinical trial system.” (Steeg referenced a perspective piece, “The Right Trials,” she wrote for Nature this past May: http://www.nature.com/nature/journal/v485/n7400_supp/full/485S58a.html)

Conference chair and MBCN board member Deb Tincher noted that many attendees cited Steeg as their favorite speaker at the 2012 event. “One person described Dr. Steeg as ‘spectacular and passionate’ and we certainly agree,” Tincher said. “We also agreed with the rest of her comment: ‘Dr. Steeg is in the trenches helping us and it showed!’ We are proud to recognize and support Dr. Steeg’s work.”

“I’m glad Dr. Steeg is on our side!” said one metastatic breast cancer patient at the 6th Annual MBCN Conference.

 

ABOUT MBCN’s ANNUAL CONFERENCE

MBCN held its first conference at Memorial Sloan-Kettering Cancer Center in 2006. Subsequent conferences have been held at M.D. Anderson, Dana-Farber, Indiana University’s Simon Cancer Center and at Johns Hopkins.

 

ABOUT THE METASTATIC BREAST CANCER NETWORK

MBCN is a national, independent, nonprofit, patient advocacy group dedicated to the unique concerns of the women and men living with metastatic breast cancer. MBCN was founded in 2004 by Jane Soyer and Nina Schulman. When diagnosed with advanced breast cancer, they experienced feelings of isolation from the very groups established to provide support. They felt the stigma of being a “failure” in the breast cancer community. Their belief that cancer cannot be viewed as a disease from which one is either a “survivor” or to which one has succumbed, fueled their desire to advocate for change.  See www.mbcn.org.

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Avastin: The Last Word

The FDA has announced that bevacizumab (Avastin) is no longer approved for the treatment of breast cancer. The Genentech drug retains its indications for colon, lung, kidney, and brain cancer and will remain on the market.

This issue has been extensively discussed in previous entries.

Rather than rehash my opinion, I’d like to share some recent commentary from others:

If there’s a shard of hope for patients, it is that Genentech is running a new Avastin breast cancer trial, with a particular emphasis on a potential subset biomarker, the protein known as vascular endothelial growth factor A. . . Genentech would not continue to spend tens of millions of dollars and risk Dr. Pazdur’s reprisals against its other medicines if it did not see some tangible therapeutic gain.–Wall Street Journal editorial

The risks of Avastin are real, but they’re also well-understood and manageable, especially in end-stage oncology where there are no good options. The FDA’s real goal was to send a warning to the rest of the drug industry about who is in charge of drug development. The FDA withdrew Avastin’s breast cancer approval last year—leading to Genentech’s unprecedented appeal and a two-day trial in June.

In her decision denying that appeal, Dr. Hamburg concedes that there are groups of “super responders” who experience dramatic improvements when treated with Avastin. But she then says those patients don’t count because “it is not possible to determine if there is some subset of patients within the population as a whole that may have had a meaningful benefit.” Dr. Hamburg also concedes that Avastin may produce better results when used with different chemotherapies, but that those prospects haven’t been sufficiently tested…

All of this suggests that Avastin should remain on the market as one treatment alternative as knowledge about the drug grows—which is all that Genentech requested in its appeal. Looking at the same studies, the European Medicines Agency (the FDA’s continental equivalent) continues to approve Avastin for breast cancer. The National Comprehensive Cancer Network, a highly respected consortium of U.S. oncology programs, has four times reaffirmed its recommendation that Avastin is “an appropriate therapeutic option.”

“The Avastin Denial: A chillingly blunt assertion of regulatory power against a drug for breast cancer”

“More research is needed to identify what biomarker identifies our subgroup.”–Patient

“I don’t disagree with the FDA decision,” says one woman who has been on it.  “We need to have drugs that are proven to extend survival and not settle for less. Avastin never lived up to its initial promise–except for some outliers and more research is needed to identify what biomarker identifies our subgroup.”

“There’s no group of hos­pitals and doctors whose profit and livelihood, respec­tively, depends on giving Avastin to just a few people with metastatic breast cancer.”–Elaine Schattner

…What I think is that Avastin is a scapegoat of sorts, a costly drug not par­tic­u­larly worse than many others, nor better, and that helps a small minority of women with a lethal disease for reasons their doctors can’t predict or explain.

What I wonder is, iron­i­cally, because the data on Avastin were col­lected so care­fully, that its lack of effec­tiveness over a pop­u­lation of women was better-​​documented than has been the lack of evi­dence for other drugs and reg­imens. Besides, there’s no group of hos­pitals and doctors whose profit and livelihood, respec­tively, depends on giving Avastin to just a few people with metastatic breast cancer. There was just Genentech, an easy big-​​Pharma target, and a few women, pleading for con­tinued access to a drug that’s helped to keep them alive.

“I would have appreciated being patronized because at least we would have been acknowledged,” Jake H., husband of Nancy, a patient who testified at the FDA hearing

“The hearing was really frustrating in that the FDA was indifferent to our pleas,” writes Nancy, a patient who testified at the hearing. “Several of the folks on the panel were so rude during the hearing they were literally reading their Blackberries during the public testimony. As [my husband] Jake commented, ‘I would have appreciated being patronized because at least we would have been acknowledged.’ So true! We were completely ignored on the first day and treated like we were wasting their time.”

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Update: Grandma McCartin Can Finally Get T-DMI in Boston (What Will She Do with the 15,500 Frequent Flier Miles She’s Earned?)

UPDATE: Jan 20, 2012
Phil McCartin reports his wife Lorraine is FINALLY able to get TDM-1 in Boston.
Great news! Now use those frequent flyer miles to go some place that isn’t VA!
Here’s what Phil says:
Those of you following This FDA’S Blocking of herceptin T DM-1 know that we had to travel from Boston to Va. to get it in 2010. And it works wonders for those who are HER 2 +. After 16 trips, and many Bureaucratic Obstacles, Lorraine finally got her platelets up over 75,000. Genentechs hurdle. her plats have been slwly going up, lows after each tx. less than before. Then they jumped 19,000 in 9 days ! Even the researchers were surprised ! She got the ok for tx. in Boston today , the 19th ! Since she was young, her ” lucky ‘ no. has been 19 ! We think its a “God Thing “. She is aTestimony for Flexible, Informed Choice in clinical testing for Stage IV Fighters. See her story on youtube :
Watch her in part 4.
UPDATE: Sept. 27, 2011

Amid glowing press accounts from the EMCC about T-DM1, there’s just one problem.

Lorraine McCartin must STILL travel 950 miles from MA to VA. Ironically, when she’s home in MA, she could throw a rock and hit ImmunoGen, T-DMI’s Waltham, MA-based co-developer.

This story  is representative of most EMCC reports:

Data from a mid-stage clinical trial of the new combination drug, trastuzumab emtansine (T-DM1), in HER2-positive breast cancer found patients given T-DM1 had a 41 percent improvement in the time without their breast cancer worsening compared with those given trastuzumab, or Herceptin, plus chemotherapy.

Side effects were also significantly reduced in the T-DM1 group, a factor that was “particularly important and very clinically meaningful“, said the study’s lead investigator Sara Hurvitz, since far fewer T-DM1 patients opted to stop treatment during the phase II trial.

The results are a boost for the medicine, which the Swiss drugmaker Roche has been developing with ImmunoGen as a successor to its blockbuster Herceptin. Herceptin had sales of more than $5 billion in 2010.

“These provocative Phase II data illustrate that first-line treatment with T-DM1 provides a longer time for patients to live without cancer progression and with fewer side effects than standard chemotherapy plus trastuzumab,” said Hurvitz, director of the breast oncology programme at University of California, Los Angeles, who presented her findings at the European Multidisciplinary Cancer Congress (EMCC) in Stockholm.

In the trial, which involved 137 patients who had not previously had chemotherapy or HER2-targeted therapy, those on T-DM1 had an average 14.2 months without the disease worsening versus 9.2 months for those given Herceptin plus chemotherapy.

Via  Facebook, Phil McCartin writes:

We started hearing from MGH last week that we might not get t dm-1 in Boston, at least not for awhile. Genentech confirmed that today. Very disappointing. The co. promised , then went back on their word, putting another hurdle in Lorrraines’ way .

It seems that when we transfer to Boston , L. enters a” new ” study ( not a trial ), and has to meet the labs, etc. that she ALREADY MET to get in the access study a yr. ago ! Lorraine has low platelets, but they are stable, and the cancer continues to shrink. She got an exception for tx. w/ low plats , granted by Gen. months ago. But the new Gen. doc, in charge of the new study, wont grant an exception for the new study.

Our doc in Va. agrees with us. He says that Lorraines response is ” remarkable ‘, ” excellent “. She can stay in Va, as that study is closed to new pts, but still treating those in it, incl. Lorraine.

We are fighting it. First the FDA decides to deny approval, then the co. wanted to close all access , until we spoke up. Now the co. breaks its promise.

Todays Globe announces that Immunogens stock soars on an analysts’ report that the T DM-1 Trial data is ” Striking “, and has ” Great Commercial Potential “.

Immunogen makes the chemo part of the drug, right here in Waltham, Mass.
With these Global Corporations ultimately its all about the $, protecting the investment, before the patient.–Our HER2 Struggle FB page

This is the original May 2011 blog post:

Positive development for HER2+ T-DM1 travelers

Lorraine Heidke-McCartin, 54, has been dealing with HER2-positive metastatic breast cancer since 2006. In August 2010, her doctors at Dana-Farber (Boston) told her she was a good candidate for Genetech’s T-DM1, a drug that has given some early users dramatic results with few side effects.
Some observers have called T-DMI “Super Herceptin. T-DM1 combines Genentech’s  antibody with a cancer-killing agent made by a Waltham, MA-based biotechnology company, ImmunoGen.
As reported in the Boston Globe, in late August, shortly before the treatments were to start under an expanded access program, the drug’s maker, the Genentech division of Roche Holding AG, shut down the program in Boston after the FDA refused to speed the approval process.Heidke-McCartin and her husband, Phil, were determined to get the drug.
Every month, at their own expense, they travel to a hospital in Fairfax, VA.
According to the Globe:  The 950-mile round trips are exhausting, but Heidke-McCartin said she manages because of her faith, her husband,  and her growing family, including five grandchildren born since her diagnosis.
“I was ready to give up,” she said, describing side effects from other cancer drugs that ranged from nausea and hair loss to yellowed palms. “Then I would look at my grandchildren and get back on my feet again.”
Genentech is moving forward with the regulatory approval process for T-DM1, but based on the current FDA timetable, it won’t reach the market before 2013. For now, it’s available only to patients in trials and those eligible for treatment at 13 expanded access sites across the country – none within 450 miles of Boston.
Phil McCartin, who lost his first wife to breast cancer, has worked tirelessly to make T-DM1 accessible to those who need the drug today. He contacted other patients on Inspire.com and BreastCancer.org. He wrote to Boston and national media. He and Lorraine went to Washington to lobby the FDA. Phil started a Facebook group: Our HER2  Struggle.
Jeanne Sather,  aka The Assertive Cancer Patient, found herself at a similar crossroads in Seattle. Sather was first diagnosed with breast cancer in 1998. Since then she has been in nearly constant treatment because her disease metastasized to her bones, lungs and brain. She had been getting T-DM1 in a clinical trial and did so well her doctor referred to her as “a star patient.”Becasue Sather could not get T-DM1 in Seattle, every three weeks she had to fly to Highland, CA.
According to a friend of Sather’s: “The travel and the constant fundraising to cover her expenses (she lives on Social Security Disability and financial help from friends) were physically and emotionally exhausting for her. She could not sustain the trips, so she had to drop out of the trial a few weeks ago.”McCartin and Sather just got some  welcome news.
According to Phil’s Facebook post:  Genentech [says]  they are ‘amending the protocol’  to allow us to GET THE DRUG IN BOSTON ! W/IN 90 DAYS OR LESS !! Women in the access program, who have responded well to the drug, and have to travel, can ask to have thier doc give them the drug. This is so awesome for us, for women who have to travel all over the country.”Remeber those women who haven’t , or can’t, get access, need the FDA to approve this wonderful drug. Thanks for all your support , financial and otherwise, for your prayers, You know who you are ! And God knows.”Sather told her readers: “One thing [my doctor said] is that he thinks my asking to get T-DM1 on compassionate use was ‘the straw that broke the camel’s back,’ because Genentech has been hearing from so many women recently who are in my situation: they could be helped by T-DM1, but they can’t travel to the nearest clinical trial site.”

Who helped Sather and McCartin?

With the exception of The Abigail Alliance, no breast cancer association or patient advocacy group cared to involve itself. Phil McCartin tried them all. His particular situation didn’t fit their mission. Sorry.

Some Genetech stockholders picked over Phil and Jeanne’s online health-related reports as a rail bird might study a tout sheet. They cheered Sather and McCartin’s success with the “miracle” drug. None seemed particularly interested in providing any practical  help with travel expenses or drug approval hurdles. Oh well.

I stand in awe of Phil and Jeanne. When people say “Be your own advocate” to a cancer patient they usually don’t add: “And start a grassroots drug access effort, even if none of  the established cancer groups will help you and even if you are one person taking on massive corporate, medical and governmental entities and even if amateur investors see you not as human beings but as a barometer of potential profits.”

Speaking of which: Both McCartin and Sather must continue to travel for T-DM1 for the next two to three months. Sather estimates her expenses will be $4,000.  If you want to help, see this page.

Rock on, Phil and Jeanne!

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