Great results about advances for the cure of cancer

A new study shows that the number of women in the United States living with distant metastatic breast cancer (MBC), the most severe form of the disease, is growing. This is likely due to the aging of the U.S. population and improvements in treatment. See the picture below, which is self-explanatory.

CANCER HELP ONLINE: FDAApproves Inotuzumab for Adults with B-Cell Acut...

CANCER HELP ONLINE: FDAApproves Inotuzumab for Adults with B-Cell Acut...: FDA Approves Inotuzumab for Adults with B-Cell Acute Lymphoblastic Leukemia An electron micrograph of a human B cell. Most...

CANCER HELP ONLINE: FDAApproves Inotuzumab for Adults with B-Cell Acut...

CANCER HELP ONLINE: FDAApproves Inotuzumab for Adults with B-Cell Acut...: FDA Approves Inotuzumab for Adults with B-Cell Acute Lymphoblastic Leukemia An electron micrograph of a human B cell. Most...

FDA Approves Inotuzumab for Adults with B-Cell Acute Lymphoblastic Leukemia

An electron micrograph of a human B cell. Most forms of acute lymphoblastic leukemia arise in B cells.

Credit: National Institute of Allergy & Infectious Diseases

The Food and Drug Administration (FDA) has approved inotuzumab ozogamicin (Besponsa®) for some adults with B-cell acute lymphoblastic leukemia (ALL).
The approval, announced on August 17, is for the use of inotuzumab in patients with B-cell ALL whose disease has stopped responding to (relapsed) or never responded to (refractory) standard chemotherapy.
Patients with B-cell ALL whose cancer has a specific genetic alteration known as the Philadelphia chromosome can receive inotuzumab only if their cancer has progressed despite treatment with one of several targeted drugs approved for this cancer type.
In the randomized phase 3 clinical trial on which the approval was based, called INO-VATE ALL, substantially more patients treated with inotuzumab discaimer had a compltete remision compared with patients treated with chemotherapy. More patients in the inotuzumab group were also minimal residual disease (MRD) negative after treatment, meaning there was no evidence of leukemia cells present in the blood or bone marrow.
Patients in the trial treated with inotuzumab also had modest improvements in how long they lived without their disease progressing and in overall survival.

More Treatment Options for ALL

Although many patients with B-cell ALL respond well to chemotherapy, their cancer often returns. For patients with ALL whose cancer cells are positive for the Philadelphia chromosome—which occurs in 25% to 40% of cases—several targeted drugs, all part of a class of drugs known as tyrosine kinase inhibitors, have proven to be effective. But, as in patients treated with standard chemotherapy, the cancer develops resistance to the treatment and returns in many of these patients.
Inotuzumab is an antibody-drug conjugate, a type of drug in which an anticancer drug is chemically linked to another molecule that helps target the drug to cancer cells.
The targeting component of inotuzumab is a monoconal antibody that targets the CD22 protein, which is produced in excess on the surface of most ALL cells. The antibody is linked to a compound called calicheamicin that kills cancer cells. Once the antibody portion of inotuzumab binds to CD22 on cancer cells, the calicheamicin is released into the cell, where it damages the cell’s DNA and causes its death.
Inotuzumab is the third new therapy approved in recent months for people with advanced B-cell ALL.
Earlier this year, FDA granted full approval of blinatumomab (Blincyto®), a form of immunotherapy, for children and adults with relapsed or refractory B-cell ALL regardless of Philadelphia chromosome status. The approval was based on the results of a large clinical trial showing that patients treated with the drug had substantial improvement in how long they lived compared with patients treated with chemotherapy.
And approximately 2 weeks after inotuzumab was approved, the agency approved tisagenlecleucel (Kymriah™), the first-ever approved CAR T-cell therapy, for children and young adults with advanced ALL. That approval was based on findings from a small clinical trial in which 83% of patients achieved a complete remission 3 months after receiving the treatment.

High Remission Rates with Inotuzumab

The more than 300 patients in the INO-VATE ALL trial—funded by Pfizer, the drug’s manufacturer—had received at least one chemotherapy regimen and, for those with Philadelphia chromosome­–positive cancers, treatment with at least one FDA-approved tyrosine kinase inhibitor.

Of the first 218 patients in the trial (the group which served as the basis for the approval), approximately 36% of patients treated with inotuzumab had a complete remission, and nearly 90% of these patients were MRD negative. The complete remission and MRD-negative rates in patients treated with chemotherapy were approximately 17% and 32%, respectively.
Among patients who achieved a complete remission, the median length of the responses was 8 months in those who received inotuzumab and 4.9 months in those who received chemotherapy.
The median progression-free survival in the trial was 5 months in patients treated with inotuzumab and 1.9 months in patients treated with chemotherapy. Median overall survival was 7.7 months and 6.7 months, respectively.

Common side effects of inotuzumab included infections, anemia, hemorrhage, and nausea. A nearly identical number of patients in both groups experienced serious side effects, with febrile neutropenia being the most frequently reported serious event.
Link: https://www.cancer.gov/news-events/cancer-currents-blog/2017/fda-inotuzumab-

Development of breast cancer can be prevented with antibiotics?

In a newly published study, Cleveland Clinic researchers have uncovered differences in the bacterial composition of breast tissue of healthy women vs. women with breast cancer. The research team has discovered for the first time that healthy breast tissue contains more of the bacterial species Methylobacterium, a finding which could offer a new perspective in the battle against breast cancer.

Bacteria that live in the body, known as the microbiome, influence many diseases.
Most research has been done on the “gut” microbiome, or bacteria in the digestive tract. Researchers have long suspected that a “microbiome” exists within breast tissue and plays a role in breast cancer but it has not yet been characterized. The research team has taken the first step toward understanding the composition of the bacteria in breast cancer by uncovering distinct microbial differences in healthy and cancerous breast tissue.
“To my knowledge, this is the first study to examine both breast tissue and distant sites of the body for bacterial differences in breast cancer,” said co-senior author Charis Eng, M.D., Ph.D., chair of Cleveland Clinic’s Genomic Medicine Institute and director of the Center for Personalized Genetic Healthcare. “Our hope is to find a biomarker that would help us diagnose breast cancer quickly and easily.  In our wildest dreams, we hope we can use microbiomics right before breast cancer forms and then prevent cancer with probiotics or antibiotics.”
Link: https://www.biosciencetechnology.com/news/2017/10/researchers-find-link-between-bacterial-imbalances-and-breast-cancer

FDA Approves a New Treatment for Acute Myeloid Leukemia

The new treatment, Vyxeos, comprises a combination of two commonly used cytotoxic chemotherapeutics inside a nanosized particle.
The U.S. Food and Drug Administration (FDA) recently approved a new treatment called Vyxeos for treating certain patients with  acute myeloid leukemia (AML).
Vyxeos is intended for the treatment of adults with two types of AML that have particularly poor prognoses: newly diagnosed therapy-related AML and AML with myelodysplasia-related changes.
AML is the form of leukemia that carries the worst prognosis; according to the National Cancer Institute, the five-year relative survival rate is just 26.9 percent.
Vyxeos provides an alternative approach to delivering two of the cytotoxic chemotherapeutics commonly used to treat many patients with AML, daunorubicin and cytarabine. Until the approval of Vyxeos, these two agents were always given separately. In Vyxeos, a fixed combination of daunorubicin and cytarabine are enclosed together in a nanosized particle.
Nanotechnology refers to the manufacturing of objects with dimensions one million times smaller than a millimeter (the smallest width of a human hair is just 50 times smaller than a millimeter). Nanomedicine is the application of nanotechnology to the research and practice of medicine. Nanodrugs comprise an anticancer agent (or agents) and a nanosized carrier that selectively delivers the anticancer agent to the cancer and protects the anticancer agent from being destroyed by the body. Thus, nanodrugs allow the delivery of higher levels of anticancer agents to cancer cells than traditional systemic delivery methods, increasing effectiveness while reducing toxic side effects.
In the case of Vyxeos, the nanosized carriers are liposmes and the anticancer agents are daunorubicin and cytarabine. According to the FDA statement, Vyxeos was approved based on results from a randomized phase III clinical trial that showed that median overall survival for patients who received the new treatment was significantly improved compared with who received daunorubicin and cytarabine separately (9.56 months compared with 5.95 months).
The FDA approval was rendered on August 3, 2017.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm569883.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery