Showing posts with label breast cancer. Show all posts
Showing posts with label breast cancer. Show all posts

Thursday, October 3, 2019

FDA Approves Piqray (alpelisib) as First PI3K Inhibitor for Breast Cancer

Alpelisib.svg

U.S. Food and Drug Administration approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer (as detected by an FDA-approved test) following progression on or after an endocrine-based regimen.
The FDA also approved the companion diagnostic test, therascreen PIK3CA RGQ PCR Kit, to detect the PIK3CA mutation in a tissue and/or a liquid biopsy. Patients who are negative by the therascreen test using the liquid biopsy should undergo tumor biopsy for PIK3CA mutation testing.
“Piqray is the first PI3K inhibitor to demonstrate a clinically meaningful benefit in treating patients with this type of breast cancer. The ability to target treatment to a patient’s specific genetic mutation or biomarker is becoming increasingly common in cancer treatment, and companion diagnostic tests assist oncologists in selecting patients who may benefit from these targeted treatments,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “For this approval, we employed some of our newer regulatory tools to streamline reviews without compromising the quality of our assessment. This drug is the first novel drug approved under the Real-Time Oncology Review pilot program. We also used the updated Assessment Aid, a multidisciplinary review template that helps focus our written review on critical thinking and consistency and reduces time spent on administrative tasks.”
Metastatic breast cancer is breast cancer that has spread beyond the breast to other organs in the body (most often the bones, lungs, liver or brain). When breast cancer is hormone-receptor positive, patients may be treated with anti-hormonal treatment (also called endocrine therapy), alone or in combination with other medicines, or chemotherapy.
The efficacy of Piqray was studied in the SOLAR-1 trial, a randomized trial of 572 postmenopausal women and men with HR-positive, HER2-negative, advanced or metastatic breast cancer whose cancer had progressed while on or after receiving an aromatase inhibitor. Results from the trial showed the addition of Piqray to fulvestrant significantly prolonged progression- free survival (median of 11 months vs. 5.7 months) in patients whose tumors had a PIK3CA mutation.
Common side effects of Piqray are high blood sugar levels, increase in creatinine, diarrhea, rash, decrease in lymphocyte count in the blood, elevated liver enzymes, nausea, fatigue, low red blood cell count, increase in lipase (enzymes released by the pancreas), decreased appetite, stomatitis, vomiting, weight loss, low calcium levels, aPTT prolonged (blood clotting taking longer to occur than it should), and hair loss.
Health care professionals are advised to monitor patients taking Piqray for severe hypersensitivity reactions (intolerance). Patients are warned of potentially severe skin reactions (rashes that may result in peeling and blistering of skin or mucous membranes like the lips and gums). Health care professionals are advised not to initiate treatment in patients with a history of severe skin reactions such as Stevens-Johnson Syndrome, erythema multiforme, or toxic epidermal necrolysis. Patients on Piqray have reported severe hyperglycemia (high blood sugar), and the safety of Piqray in patients with Type 1 or uncontrolled Type 2 diabetes has not been established. Before initiating treatment with Piqray, health care professionals are advised to check fasting glucose and HbA1c, and to optimize glycemic control. Patients should be monitored for pneumonitis/interstitial lung disease (inflammation of lung tissue) and diarrhea during treatment. Piqray must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.
Piqray is the first new drug application (NDA) for a new molecular entity approved under the Real-Time Oncology Review (RTOR) pilot program, which permits the FDA to begin analyzing key efficacy and safety datasets prior to the official submission of an application, allowing the review team to begin their review and communicate with the applicant earlier. Piqray also used the updated Assessment Aid (AAid), a multidisciplinary review template intended to focus the FDA’s written review on critical thinking and consistency and reduce time spent on administrative tasks. 
https://en.wikipedia.org/wiki/Alpelisib
https://pubchem.ncbi.nlm.nih.gov/compound/Alpelisib

Thursday, November 22, 2018

Breast Cancer Drug Promising in Phase 3 Trial


Talazoparib.svg

 For women with advanced breast cancer who carry the BRCA1 and BRCA2 gene mutations, an experimental drug could improve survival, a new study suggests.

The BRCA mutations are linked with a greater risk for aggressive breast and ovarian cancer. The drug, talazoparib, works by blocking an enzyme called poly ADP ribose polymerase (PARP), thus preventing cancer cells from killing healthy ones.
In a phase 3 trial of 431 women, funded by the drug's maker, those who received talazoparib lived longer without their cancer progressing than women treated with standard chemotherapy by an average of three months, researchers found.
"For women with metastatic breast cancer and a BRCA mutation, PARP inhibitors may be considered for their treatment," said lead researcher Dr. Jennifer Litton, an associate professor of breast medical oncology at the University of Texas M.D. Anderson Cancer Center in Houston.
When it's functioning properly, BRCA actually helps repair damaged DNA and prevents tumors, but when BRCA1 and BRCA2 go awry, they encourage breast cancers.
PARP inhibitors such as talazoparib appear to interfere with the function of mutated BRCA in breast cells, causing them to die rather replicate.
In addition, several ongoing studies are looking at combinations with PARP inhibitors "to try to expand who may benefit or lengthen how long they may work," Litton said.The trial results are preliminary, as talazoparib has not yet been approved by the U.S. Food and Drug Administration.
In January, the FDA approved the first PARP inhibitor, Lynparza, to treat BRCA-mutated breast cancer.
Similar drugs have already been used to treat advanced, BRCA-mutated ovarian cancer, according to the agency.
In the current trial, the women who were randomly selected to receive talazoparib had a higher response rate to treatment than women who received standard chemotherapy: 63 percent versus 27 percent, the researchers found.
The drug does have side effects. Among women receiving talazoparib, 55 percent had blood disorders, mostly anemia, compared with 38 percent of those receiving standard chemotherapy.
In addition, 32 percent of the women receiving talazoparib had other side effects, compared with 38 percent of those on standard chemotherapy.
Oncologist Dr. Marisa Weiss is the founder and chief medical officer of Breastcancer.org. "Smart medicines like this PARP inhibitor work better than traditional chemo in women with HER2-negative metastatic disease and a BRCA1/2 genetic mutation," she said.
This targeted form of treatment takes advantage of a weakness in the BRCA gene to further cripple the cancer cell's ability to repair itself, grow and spread, said Weiss, who was not involved with the study.
Normal cells are mostly spared. As a result, more cancer cells are killed with fewer side effects, Weiss said.
"Most importantly, patients themselves have reported a better experience with less hair loss and improved quality of life," she said.
Weiss advises women with advanced breast cancer to have genetic testing.
"In both my clinical practice and within the online support community, we advise women with metastatic breast cancer to get genetic testing upon diagnosis, in order to get the best care first," she said.


The trial was funded by drug maker Pfizer, and the results were published Aug. 15 in the New England Journal of Medicine.
https://www.nejm.org/doi/full/10.1056/NEJMoa1802905

Ref : https://en.wikipedia.org/wiki/Talazoparib

Monday, March 21, 2016

FDA approves non-alcoholic Docetaxel Injection

Docetaxel.svg
In continuation of my update on Docetaxel


Teikoku Pharma USA, Inc. ("Teikoku" or "the Company") announced today that the U.S. Food and Drug Administration ("FDA") has approved Docetaxel Injection, Non-Alcohol Formula ("Docetaxel Injection") for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer. Teikoku entered into an exclusive licensing agreement with Eagle Pharmaceuticals Inc. ("Eagle Pharmaceuticals") in October 2015 to market, sell and distribute Docetaxel Injection in the U.S.

The main difference, compared to other docetaxel formulations, is that Docetaxel Injection is the first non-alcohol formulation approved in the U.S. Further differentiating it from some of the currently marketed docetaxel formulations is that Teikoku's Docetaxel Injection:
  • Requires no prior dilution with a diluent and is ready to add to the infusion solution; and
  • Is available in three presentations: 20mg/ml in single-dose vials, and 80 mg/4 mL or 160 mg/8 mL in multiple-dose vials.............

Tuesday, August 4, 2015

FDA Approves Ibrance (palbociclib) for Postmenopausal Women with Advanced Breast Cancer



Palbociclib.svg


In continuation of my update on palbociclib

The U.S. Food and Drug Administration today granted accelerated approval to Ibrance (palbociclib) to treat advanced (metastatic) breast cancer.

Breast cancer in women is the second most common type of cancer in the United States. It forms in the breast tissue and in advanced cases, spreads to surrounding normal tissue. The National Cancer Institute estimates that 232,670 American women were diagnosed with breast cancer and 40,000 died from the disease in 2014.
Ibrance works by inhibiting molecules, known as cyclin-dependent kinases (CDKs) 4 and 6, involved in promoting the growth of cancer cells. Ibrance is intended for postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have not yet received an endocrine-based therapy. It is to be used in combination with letrozole, another FDA-approved product used to treat certain kinds of breast cancer in postmenopausal women.

Monday, August 26, 2013

New approach in the treatment of breast cancer

Scientists at the MedUni Vienna, in collaboration with a working group led by Nancy Hynes at the University of Basel, have discovered a new approach in the treatment of breast cancer: an international team involving the Clinical Institute of Pathology at the MedUni Vienna has been able to demonstrate the activation of a receptor, the Ret protein (Rearranged during transfection), on the surface of breast cancer cells. Increased levels of this protein are associated with a lower likelihood of survival for breast cancer patients.


Read more about RET Inhibitors at : http://www.cancercommons.org/tag/ret-inhibitors/

Monday, November 19, 2012

Breast cancer drug, geldanamycin could halt other tumors

The drug, geldanamycin, is well known for attacking a protein associated with the spread of breast cancer. However, a laboratory-based study found it also degraded a different protein that triggers blood vessel growth.

Ref : http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0048539

Monday, June 11, 2012

Combination of vaccine and letrozole effectively improves survival from breast cancer

In continuation of my update on Letrozole

Combination of vaccine and letrozole effectively improves survival from breast cancer: A vaccine that targets cancer cells in combination with the drug letrozole, a standard hormonal therapy against breast cancer, significantly increased survival when tested in mice, a team of UC Davis investigators has found.

Friday, December 17, 2010

Soy isoflavone intake decreases risk of invasive breast tumor.....

                                             

Genistein                                                                          Daidzein

Increased phytoestrogens commonly found in dietary soy may modify the risk of some types of breast cancer, according to findings presented at the Ninth Annual AACR Frontiers in Cancer Prevention Research Conference, held Nov. 7-10, 2010.

Anne Weaver and colleagues evaluated 683 women with breast cancer and compared them with 611 healthy women. Dietary data patterns were observed using a food frequency questionnaire and isoflavones were measured as a dietary, rather than supplemental, intake. Isoflavone (as for as my knowledge goes, above two isoflavones- see structures are present in soya) intake was divided into three groups. Those women with the highest isoflavone intake had an approximately 30 percent decreased risk of having an invasive breast tumor, and an approximately 60 percent decreased risk of having a grade 1 tumor. Among premenopausal women, the highest intake of isoflavones had a 30 percent decreased risk of stage I disease, a 70 percent decreased risk of having a tumor larger than 2 cm, and a 60 percent decreased risk of having stage 2 breast cancer. These connections were not seen among postmenopausal women...

Ref : http://www.buffalo.edu/news/fast-execute.cgi/article-page.html?article=120510009

Tuesday, November 23, 2010

Asthma Drug Prevents Spread of Breast Cancer, Study Finds......



We know that. Tranilast (structure, brand name Rizaben) is an antiallergic drug. It was developed by Kissei Pharmaceuticals and was approved in 1982 for use in Japan and South Korea for bronchial asthma. Indications for keloid and hypertrophic scar were added in 1993. It has been used for the treatment of allergic disorders such as asthma, allergic rhinitis and atopic dermatitis. It has been also reported that it reduces (in-vitro) collagen synthesis in fibroblasts, inhibits the growth of neurofibroma cells and inhibits ( in-vitro) the production of interleukin-6 in endothelial cells.

Now researchers from St. Michael's Hospital, Canada reports that the drug to stop the spread of breast cancer cells traditionally resistant to chemotherapy.

Researchers grew breast cancer stem cells, which give rise to other cancer cells, in culture. The cells were injected into two groups of mice, including one group, which was also treated with tranilast. Dr. Prud'homme and his colleagues found the drug reduced growth of the primary cancerous tumour by 50 per cent and prevented the spread of the cancer to the lungs. Researchers also identified a molecule in the cancer cell that binds to tranilast and appears to be responsible for this anti-cancer effect.

As per the researchers 'Tranilast' binds to a molecule known as the aryl hydrocarbon receptor (AHR), which regulates cell growth and some aspects of immunity. This makes the drug beneficial in treating allergies, inflammatory diseases and cancer.

"For the first time, we were able to show that tranilast shows promise for breast cancer treatment in levels commonly well-tolerated by patients who use the drug for other medical conditions," Dr. Prud'homme said. "These results are very encouraging and we are expanding our studies. Further studies are necessary to determine if the drug is effective against different types of breast and other cancers, and its interaction with anti-cancer drugs.........


Ref : http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0013831

Tuesday, June 15, 2010

Eribulin mesylate drug may help extend lives of women with advanced breast cancer..

We know that, Eribulin (see structure E7389) is an investigational  anticancer drug. Eribulin was previously known as E7389.  Eribulin is currently being investigated by Eisai Co. for the third-line treatment of advanced breast cancer in patients who have been previously treated with anthracyclines, taxanes and capecitabine, as well as a variety of other solid tumors, including non-small cell lung cancer, prostate cancer and sarcoma.


Structurally, eribulin is a fully synthetic macrocyclic ketone analogue of the marine sponge natural product halichondrin B a potent mitotic inhibitor with a unique mechanism of action found in the Halichondria genus of sponges. Eribulin is a mechanistically-unique inhibitor of microtubule dynamics, exerting its anticancer effects by triggering apoptosis of cancer cells following prolonged mitotic blockage. A new synthetic route to E7389 was published in 2009.

Now   research team at the University of Leeds and St James's Institute of Oncology led an international trial of the new chemotherapy drug, eribulin mesylate. As per the claim by the researchers, average survival was typically 25 per cent longer for women who took eribulin mesylate.


In the EMBRACE trial, 762 patients with advanced breast cancer received either eribulin or standard cancer treatment. All of the patients had already been heavily treated with conventional therapies, but their disease had returned or spread to other parts of the body.  Researchers concluded that those who took the new drug lived for 13.1 months, on average, compared with 10.7 months for those on conventional chemotherapy. The drug was also well-tolerated by most patients. Researchers hope that these results may establish eribulin as a new, effective treatment for women with late-stage metastatic breast cancer (either single drug or in combination with other anticancer drug). The drug is not yet available for routine clinical treatment and is awaiting regulatory approval in the European Union, the US and Japan.


"Until now, there hasn't really been a standard treatment for women with such advanced breast cancer. For those women who have already received all of the recognised treatments, these are promising results, claims the lead investigator Professor Christopher Twelves...


Ref : http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=74&abstractID=50309

Tuesday, December 15, 2009

Combination of Lapatinib and Trastuzumab a better treatment for breast cancer....

Lapatinib or lapatinib ditosylate is an orally active chemotherapeutic drug treatment for solid tumours such as breast cancer. Patients who meet specific indication criteria may be prescribed lapatinib as part of combination therapy for breast cancer. On March 13, 2007, FDA approved lapatinib in combination therapy for breast cancer patients already using capecitabine.

Recently, researchers from Duke University Medical Center. Dr. Kimberly Blackwell have found more interesting results when they did try the combination of Trastuzumab (monoclonal antibody). As per the claim by the researchers, Lapatinib plus trastuzumab are significantly better than lapatinib alone in extending the lives of breast cancer patients whose tumors are HER2-positive.

Blackwell says, the combination targeted therapy gave patients more than a four-month survival advantage over those who took lapatinib alone. She says the findings may be the first step toward a chemotherapy-free future. This is the first time that a pair of targeted therapies has been shown to be superior to any intervention that paired a targeted therapy with a hormonal or chemotherapy based approach, she said. The interesting claim by the researchers trastuzumab binds to and blocks part of the HER2 growth factor that appears on the surface of some breast cancer cells while lapatinib binds to a second growth factor, EGFR, and part of HER2 that sits below the cell surface. It's sort of a double whammy, disabling the HER2 protein in two places instead of one......

Ref : http://www.dukehealth.org/health_library/news/targeted_therapy_prolongs_life_in_patients_with_her2_positive_breast_cancer