Claim: New drugs show rare promise against advanced breast cancer.
Verdict: SUPPORTS

Retrieved passages:
title: MTOR inhibitors
text: non-small-cell lung cancer, and other advanced solid tumors. While common toxicities included nausea, stomatitis, and anemia; responses were noted. Everolimus is the second novel Rapamycin analog. From March 30, 2009 to May 5, 2011 the U.S. FDA approved everolimus for the treatment of advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib, subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS), and progressive neuroendocrine tumors of pancreatic origin (PNET). In July and August 2012, two new indications were approved, for advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, and pediatric and adult patients with

title: Masato Tanabe
text: A compound discovered in a previous contract from NIH showed potential - it acted like "anti-estrogen" in the breasts and uterus but like normal estrogen elsewhere in the body, and were thus more "tissue-selective". A contract was proposed to Taiho Pharmaceutical in July 1996, and within six years and slightly under $3 million (an unusually short amount of time) two new drugs were discovered and tested on people (particularly people for which tamoxifen has failed): SR16234 and SR16287. The first of those, SR16234, also inhibited the growth of blood vessels (angiogenesis) and accelerated the death of cancer cells (apoptosis) and

title: Treatment of lung cancer
text: EML4-ALK fusion oncogene, and is approved by the FDA. EML4-ALK is found in some relatively young, never or light smokers with adenocarcinoma. Advances in cytotoxic drugs, pharmacogenetics and targeted drug design show promise. A number of targeted agents are at the early stages of clinical research, such as cyclo-oxygenase-2 inhibitors, the apoptosis promoter exisulind, proteasome inhibitors, bexarotene, the epidermal growth factor receptor inhibitor cetuximab, and vaccines. Sorafenib (marketed as Nexavar for use in renal and liver cancer) showed promise in a clinical trial matching targeted treatment to the cancer's genetic profile. Future areas of research include ras proto-oncogene inhibition, phosphoinositide

title: Cancer vaccine
text: of a phase III clinical trial. The approval is for a subset of kidney cancer patients who are at intermediate risk for disease recurrence. It awaits approval in the US and EU. but will need a new trial for FDA approval. Interim results from a phase III trial of talimogene laherparepvec in melanoma showed a significant tumour response compared to administration of GM-CSF alone. Oncophage was approved in Russia in 2008 for kidney cancer. It is marketed by Antigenics Inc. Sipuleucel-T, Provenge, was approved by the FDA in April 2010 for metastatic hormone-refractory prostate cancer. It is marketed by Dendreon

title: Veliparib
text: trials, for advanced ovarian cancer, triple-negative breast cancer and in non-small cell lung cancer (NSCLC). In 2017, AbbVie reported that veliparib failed to improve outcomes in the triple-negative breast cancer and NSCLC trials. Veliparib Veliparib (ABT-888) is a potential anti-cancer drug acting as a PARP inhibitor. It kills cancer cells by blocking a protein called PARP, thereby preventing the repair of DNA or genetic damage in cancer cells and possibly making them more susceptible to anticancer treatments. Veliparib may make whole brain radiation treatment work more effectively against brain metastases from NSCLC. It has been shown to potentiate the effects

title: Bionovo
text: effect is blunted due to their different metabolic profile. Cancer cells attempt but ultimately fail to repair DNA damage that results in the inhibition of glycolysis and cancer cell death while normal cells remain unharmed. Bezielle has completed Phase 1A and 1B clinical trials for advanced metastatic breast cancer. Seala (also known as VG101) for vaginal atrophy was approved by the FDA to begin a Phase I/II clinical trial upon receipt of funding. BN107 and BN108, both designed to treat advanced breast cancer, are slated to begin Phase I/II clinical trials upon funding. Bezielle was scheduled to begin a Phase

title: Bcr-Abl tyrosine-kinase inhibitor
text: analog or a novel way to inhibit TKs. Rebastinib (DCC-2036) Also an inhibitor of TIE-2 and VEGFR-2. It has had a phase 1 clinical trial for Leukemias (Ph+ CML With T315I Mutation). It is in a phase 1 clinical trial of combination therapy for metastatic breast cancer. Imatinib remains a standard frontline TKI. Nilotinib and dasatinib are also approved by the FDA as a frontline drugs, in June and October 2010 respectively. Four of these drugs, nilotinib, dasatinib, bosutinib and ponatinib are approved for the treatment of imatinib resistant or intolerant CML. The first line data for these compounds are

title: Specialty drugs in the United States
text: results". Shortly after the law was enacted, Ivacaftor, in January 2013, became the first drug to receive the breakthrough therapy designation. On February 3, 2015 New York-based Pfizer's drug Ibrance was approved through the FDA's Breakthrough Therapy designation program as a treatment for advanced breast cancer. It can only be ordered through specialty pharmacies and sells for "$9,850 for a month or $118,200 per year". According to a statement by the New York-based Pfizer the price "is not the cost that most patients or payors pay" since most prescriptions are dispensed through health plans, which negotiate discounts for medicines or

title: Institute of Cancer Research
text: ICR has been working to develop drugs that inhibit BRAF in melanoma and other cancers where the gene is defective. In the five years from 2004/05, the ICR developed on average two drug development candidates per year. Since 2006, it has licensed three novel series of anti-cancer drugs to major pharmaceutical companies: Hsp90 inhibitors to Novartis, PKB inhibitors to AstraZeneca and PI3Kinase inhibitors to Genentech. The PIl3Kinase inhibitor GDC-0941, licensed to Genentech by Piramed, is thought to have potential in a range of human cancers. In laboratory experiments, ICR scientists found that the drug reduced the growth of glioblastoma (the

title: Atezolizumab
text: and standard chemotherapy for some patients with lung cancer was granted priority review. In October 2018, a combined clinical trial of the drug with nab-paclitaxel on patients with advanced triple negative breast cancer concluded. In May 2016 FDA granted accelerated approval to atezolizumab for locally advanced or metastatic urothelial carcinoma treatment after failure of cisplatin-based chemotherapy. The confirmatory trial (to convert the accelerated approval into a full approval) failed to achieve its primary endpoint of overall survival. In October 2016, FDA approved atezolizumab for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose disease progressed during or

title: Metastatic breast cancer
text: Vinorelbine is also active in metastatic breast cancer. Eribulin was approved in the US in Nov 2010. A targeted therapy drug, Kadcyla, was approved in February 2013. This antibody-drug conjugate targets only cancerous cells. It works by only releasing its toxic payload when triggered by a protein found in the cancerous cells in HER2+ breast cancer. It has extremely low side effects using this target therapy method. For estrogen-receptor-positive metastatic breast carcinoma the first line of therapy is often tamoxifen or another anti-estrogen drug unless there are liver metastases, significant lung involvement, rapidly progressive disease or severe symptoms requiring immediate

title: HER2/neu
text: combination with trastuzumab in June 2012. As of November 2015, there are a number of ongoing and recently completed clinical trials of novel targeted agents for HER2+ metastatic breast cancer, e.g. margetuximab. Additionally, NeuVax (Galena Biopharma) is a peptide-based immunotherapy that directs "killer" T cells to target and destroy cancer cells that express HER2. It has entered phase 3 clinical trials. It has been found that patients with ER+ (Estrogen receptor positive)/HER2+ compared with ER-/HER2+ breast cancers may actually benefit more from drugs that inhibit the PI3K/AKT molecular pathway. Over-expression of HER2 can also be suppressed by the amplification of

title: Sunitinib
text: a treatment. Between April 2009 and May 2011 Pfizer has reported unsuccessful late-stage trials in breast cancer, metastatic colorectal cancer, advanced non-small-cell lung cancer, and castration-resistant prostate cancer. The drug was discovered at SUGEN, a biotechnology company which pioneered protein kinase inhibitors. It was the third in a series of compounds including SU5416 and SU6668. The concept was of an ATP mimic that would compete with ATP for binding to the catalytic site of receptor tyrosine kinases. This concept led to the invention of many small-molecule tyrosine kinase inhibitors, including Gleevec, Sutent, Tarceva and many others. Sunitinib adverse events are

title: Metastatic breast cancer
text: research. Several medications are in development or in phase I/II trials. Typically new medications and treatments are first tested in metastatic cancer before trials in primary cancer are attempted. Another area of research is finding combination treatments which provide higher efficacy with reduced toxicity and side effects. Experimental medications: Scheduling of drug treatments and combination treatment can have substantial impact on treatment efficacy. Nanomedicine is being studied, and there are several developments involving the targeting of cancer cells using nanoprobes. Some instances where nanoprobes are used to target specific tumor cells (based on the organ to which they have metastasized)

title: CDK inhibitor
text: positive and HER2 negative advanced or metastatic breast cancer after the completion of the MONARCH 2 global Phase 3 clinical trial. CDK inhibitor A CDK (cyclin-dependent kinase) inhibitor is any chemical that inhibits the function of CDKs. They are used to treat cancers by preventing overproliferation of cancer cells. The US FDA approved the first drug of this type, palbociclib (Ibrance), a CDK4/6 inhibitor, in February 2015, for use in postmenopausal women with breast cancer that is estrogen receptor positive and HER2 negative. Several compounds are in clinical trials. In many human cancers, CDKs are overactive or CDK-inhibiting proteins are

title: Breast cancer classification
text: platinum-based chemotherapy. mTOR inhibitors such as everolimus may show more effect in PIK3CA/Akt e9 mutants than in e20 mutants or wild types. DNA methylation patterns can epigenetically affect gene expression in breast cancer and may contribute to some of the observed differences between genetic subtypes. Tumors overexpressing the Wnt signaling pathway co-receptor low-density lipoprotein receptor-related protein 6 (LRP6) may represent a distinct subtype of breast cancer and a potential treatment target. Numerous clinical investigations looked at whether testing for variant genotype polymorphic alleles of several genes could predict whether or not to prescribe tamoxifen; this was based on possible differences

title: Adjuvant therapy
text: which the potential benefits must be evaluated against the toxicity and cost of treatment and other potential side effects. Giving two or more chemotheraputic agents at once may decrease the chances of recurrence of the cancer, and increase overall survival in patients with breast cancer. Commonly used combination chemotherapy regimines used include: Roughly 15% of ovarian cancers are detected at the early stage, at which the 5-year survival rate is 92%. A Norwegian meta-analysis of 22 randomized studies involving early-stage ovarian cancer revealed the likelihood that 8 out of 10 women treated with cisplatin after the initial surgery were overtreated.

title: Cancer
text: more cytotoxic anti-neoplastic drugs (chemotherapeutic agents) as part of a standardized regimen. The term encompasses a variety of drugs, which are divided into broad categories such as alkylating agents and antimetabolites. Traditional chemotherapeutic agents act by killing cells that divide rapidly, a critical property of most cancer cells. Targeted therapy is a form of chemotherapy that targets specific molecular differences between cancer and normal cells. The first targeted therapies blocked the estrogen receptor molecule, inhibiting the growth of breast cancer. Another common example is the class of Bcr-Abl inhibitors, which are used to treat chronic myelogenous leukemia (CML). Currently, targeted

title: Lung cancer
text: factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors, new drugs are in development. New EGFR inhibitors include afatinib and dacomitinib. An alternative signaling pathway, c-Met, can be inhibited by tivantinib and onartuzumab. New ALK inhibitors include crizotinib and ceritinib. If the MAPK/ERK pathway is involved, the BRAF kinase inhibitor dabrafenib and the MAPK/MEK inhibitor trametinib may be beneficial. Lung cancer stem cells are often resistant to conventional chemotherapy and radiotherapy. This may lead to relapse after treatment. New approaches target protein or glycoprotein markers that are specific to the stem cells. Such markers include CD133, CD90, ALDH1A1,

title: Veliparib
text: compound (A 620223). The FDA awarded orphan drug status in November 2016 for NSCLC. As of 2017, 96 clinical trials involving veliparib had been registered with the FDA. It was included in the I-SPY2 breast cancer trial. Numerous phase I clinical trials are in progress. Over 40 phase II clinical trials have been registered, for indications such as metastatic melanoma, breast cancer, NSCLC, prostate cancer and brain tumors associated with metastatic primary tumors. Combination trials have evaluated velibarib in combination with doxorubicin, temozolomide, topotecan, carboplatin, paclitaxel, pemetrexed, cyclophosphamide, gemcitabine, and others. By June 2014 it was in three phase III