Great News - I was watching our local news tonight and a news story came on about a Sarasota woman who wanted to share her story about her journey thru cancer. She is calling this medicine/treatment a game changer - it saved and changed her life. NO chemo and NO radiation with this treatment. The FDA approval came Thursday this week.
She was treated by the same Cancer Doctors office "Florida Cancer Specialists" that treated me. So cool.
She was treated by the same Cancer Doctors office "Florida Cancer Specialists" that treated me. So cool.
Here is the story and video from tonights ABC News 7 - Suncoast News -
Thank you to them and Taylor Torregano..
Sarasota cancer survivor’s treatment gets FDA approval (Source: Taylor Torregano)
By Taylor Torregano | August 16, 2019 at 6:51 PM EDT - Updated August 16 at 6:51 PM
SARASOTA, Fla. (WWSB) - A significant stride in the world of medicine has roots in Sarasota.
On Thursday, a local woman’s lung cancer treatment was approved by the FDA.
Pamela Klein is calling the medicine a game changer. She said when someone is diagnosed with cancer, many doctors will recommend they immediately start chemotherapy or radiation.
But this new treatment targets the mutation instead and it’s one Pamela never would have known about without a clinical trial.
As she looked out to the canal behind her home, Pamela Klein remembered back to four years ago when her whole life quickly changed.
“I would get up to have a shower, but I wouldn’t have enough energy and I wouldn’t be able to get enough air, and energy to actually get dressed,” said Klein.
She was a 45-year-old, avid tennis player. A mom of two, who never even ate fast food. Perfectly healthy, until a cough, first thought to be a cold, then asthma, was really several tumors in her lungs.
“So I did have radiation and in fact, the machine was pointed to 12 different locations around my body all aiming here, but to try to avoid my heart,” showed Klein.
Still her health continued to decline, until she enrolled in her second clinical trial.
“Literally the week before I went on it, I didn’t know if it was my last two days,” she said.
Doctors found that her tumors had a rare gene mutation called ROS1.
This is what drives the cancer, so during that trial, Florida Cancer Specialists decided to try something new.
Pamela took a pill called Rozlytrek that so far, has specifically blocked the proteins her gene mutations need in order to grow.
“The cancer’s still there, it’s driven by my own genes, but it doesn’t grow. So as long as the medicine works, I can have a fairly normal life,” she said.
But Pamela said it doesn’t just treat her version of lung cancer.
“This is a medicine that’s specifically for mutations that are driving the cancer," said Klein. "My particular mutation, they’ve found in like nine different cancers.”
Pancreatic, ovarian, colon, breast cancer, just to name a few, which is why Pamela is telling her story. She is urging those who have just been diagnosed to do their research before going straight to chemotherapy.
After eight months of taking Rozlytrek, her tumors had shrunk significantly.
Now, it’s been three years of taking what she called the miracle medicine.
She did add though that since cancer is smart, one day the Rozlytrek will probably stop working.
At that point, she plans to enroll in another clinical trial.
Copyright 2019 WWSB. All rights reserved.
https://www.mysuncoast.com/2019/08/16/sarasota-cancer-survivors-treatment-gets-fda-approval/
Thank you to them and Taylor Torregano..
Sarasota cancer survivor’s treatment gets FDA approval (Source: Taylor Torregano)
By Taylor Torregano | August 16, 2019 at 6:51 PM EDT - Updated August 16 at 6:51 PM
SARASOTA, Fla. (WWSB) - A significant stride in the world of medicine has roots in Sarasota.
On Thursday, a local woman’s lung cancer treatment was approved by the FDA.
Pamela Klein is calling the medicine a game changer. She said when someone is diagnosed with cancer, many doctors will recommend they immediately start chemotherapy or radiation.
But this new treatment targets the mutation instead and it’s one Pamela never would have known about without a clinical trial.
As she looked out to the canal behind her home, Pamela Klein remembered back to four years ago when her whole life quickly changed.
“I would get up to have a shower, but I wouldn’t have enough energy and I wouldn’t be able to get enough air, and energy to actually get dressed,” said Klein.
She was a 45-year-old, avid tennis player. A mom of two, who never even ate fast food. Perfectly healthy, until a cough, first thought to be a cold, then asthma, was really several tumors in her lungs.
“So I did have radiation and in fact, the machine was pointed to 12 different locations around my body all aiming here, but to try to avoid my heart,” showed Klein.
Still her health continued to decline, until she enrolled in her second clinical trial.
“Literally the week before I went on it, I didn’t know if it was my last two days,” she said.
Doctors found that her tumors had a rare gene mutation called ROS1.
This is what drives the cancer, so during that trial, Florida Cancer Specialists decided to try something new.
Pamela took a pill called Rozlytrek that so far, has specifically blocked the proteins her gene mutations need in order to grow.
“The cancer’s still there, it’s driven by my own genes, but it doesn’t grow. So as long as the medicine works, I can have a fairly normal life,” she said.
But Pamela said it doesn’t just treat her version of lung cancer.
“This is a medicine that’s specifically for mutations that are driving the cancer," said Klein. "My particular mutation, they’ve found in like nine different cancers.”
Pancreatic, ovarian, colon, breast cancer, just to name a few, which is why Pamela is telling her story. She is urging those who have just been diagnosed to do their research before going straight to chemotherapy.
After eight months of taking Rozlytrek, her tumors had shrunk significantly.
Now, it’s been three years of taking what she called the miracle medicine.
She did add though that since cancer is smart, one day the Rozlytrek will probably stop working.
At that point, she plans to enroll in another clinical trial.
Copyright 2019 WWSB. All rights reserved.
https://www.mysuncoast.com/2019/08/16/sarasota-cancer-survivors-treatment-gets-fda-approval/
Here is the FDA Press Release
FDA NEWS RELEASE
FDA approves third oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor. FDA also approves drug for second indication in a type of lung cancer
For Immediate Release: August 15, 2019
The U.S. Food and Drug Administration today granted accelerated approval to Rozlytrek (entrectinib), a treatment for adult and adolescent patients whose cancers have the specific genetic defect, NTRK (neurotrophic tyrosine receptor kinase) gene fusion and for whom there are no effective treatments.
“We are in an exciting era of innovation in cancer treatment as we continue to see development in tissue agnostic therapies, which have the potential to transform cancer treatment. We’re seeing continued advances in the use of biomarkers to guide drug development and the more targeted delivery of medicine,” said FDA Acting Commissioner Ned Sharpless, M.D. “Using the FDA’s expedited review pathways, including breakthrough therapy designation and accelerated approval process, we’re supporting this innovation in precision oncology drug development and the evolution of more targeted and effective treatments for cancer patients. We remain committed to encouraging the advancement of more targeted innovations in oncology treatment and across disease types based on our growing understanding of the underlying biology of diseases.”
CLICK HERE TO READ THE REST OF THE PRESS RELEASE
https://www.fda.gov/news-events/press-announcements/fda-approves-third-oncology-drug-targets-key-genetic-driver-cancer-rather-specific-type-tumor
FDA NEWS RELEASE
FDA approves third oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor. FDA also approves drug for second indication in a type of lung cancer
For Immediate Release: August 15, 2019
The U.S. Food and Drug Administration today granted accelerated approval to Rozlytrek (entrectinib), a treatment for adult and adolescent patients whose cancers have the specific genetic defect, NTRK (neurotrophic tyrosine receptor kinase) gene fusion and for whom there are no effective treatments.
“We are in an exciting era of innovation in cancer treatment as we continue to see development in tissue agnostic therapies, which have the potential to transform cancer treatment. We’re seeing continued advances in the use of biomarkers to guide drug development and the more targeted delivery of medicine,” said FDA Acting Commissioner Ned Sharpless, M.D. “Using the FDA’s expedited review pathways, including breakthrough therapy designation and accelerated approval process, we’re supporting this innovation in precision oncology drug development and the evolution of more targeted and effective treatments for cancer patients. We remain committed to encouraging the advancement of more targeted innovations in oncology treatment and across disease types based on our growing understanding of the underlying biology of diseases.”
CLICK HERE TO READ THE REST OF THE PRESS RELEASE
https://www.fda.gov/news-events/press-announcements/fda-approves-third-oncology-drug-targets-key-genetic-driver-cancer-rather-specific-type-tumor
Below is another video from Fl Cancer Specialists
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