Afatinib receives broadened approval for NSCLC
January 2018
The Food and Drug Administration (FDA) has granted approval for broadened use of afatinib in first-line treatment of patients with metastatic non-small cell lung cancer
read more »Alectinib approved for ALK positive NSCLC
November 2017
The Food and Drug Administration (FDA) granted approval to the drug alectinib for the treatment of non-small cell lung cancer
read more »Dabrafenib and Trametinib Gets Accelerated Approval by FDA for NSCLC treatment
June 2017
The Food and Drug Administration (FDA) granted accelerated approval to the drug Dabrafenib in combination with Trametinib for patients with Non-Small Cell Lung Cancer.
read more »Lartruvo Gets Accelerated Approval by FDA for Sarcoma treatment
October 2016
The Food and Drug Administration (FDA) granted accelerated approval to the drug Lartruvo (olaratumab) in combination with doxorubicin for patients with soft tissue sarcomas.
read more »Reversal of Crizotinib Resistance
January 2016
Treatment of NSCLC’s which have EGFR or ALK mutations involves the drug crizotinib. Initially effective, tumors become resistant. Dr Alice Shaw describes a patient who became resistant to crizotinib, and then to second and third generation ALK inhibitors as well. The tumor was then found to have a novel mutation in ALK, which reversed resistance so the patient again could be treated with crizotinib.
read more »FDA approves crizotinib (Xalkori) for certain NSCLC patients
March 11, 2016
In 2011, Crizotinib was initially approved for Non-Small Cell Lung Cancer (NSCLC) patients with genetic alterations of ALK in their tumors. Another study of certian NSCLC patients with genetic alterations of the ROS1 gene, the objective response rate was 66%, with a median duration of response of 18 months. Based on this important study, crizotinib was granted breakthrough therapy designation by the FDA and was approved on March 11, 2016.
read more »Exciting Ceritinib study results for ALK-rearranged non-small cell lung cancer (NSCLC) patients who have become resistant to treatment with crizotinib
March 23, 2016
Alice Shaw, MD, PhD, of the MGH Thoracic Oncology Program has recently reported the results of an important study involving the treatment of a subset of NSCLC patients. The study, published in The Lancet Oncology in March of 2016, reported exciting results, in which patients were treated with a different ALK inhibitor, ceritinib, which has good brain penetrance for patients with brain metastasis of their NCSLC
read more »Breakthrough Therapy Designation Granted to BI 1482694 for the Treatment of Patients with EGFR-mutated NSCLC
December 21, 2015
Breakthrough Therapy Designation Granted to BI 1482694 for the Treatment of Patients with EGFR-mutated NSCLC
read more »U.S. Food and Drug Administration (FDA) grants accelerated approval to Alecensa (alectinib)
December 11, 2015
U.S. Food and Drug Administration (FDA) grants accelerated approval to Alecensa (alectinib) for the treatment of patients with anaplastic lymphoma kinase (ALK)-rearranged metastatic non-small cell lung cancer (mNSCLC), who have progressed on (or are intolerant to) crizotinib treatment.
read more »U.S. Food and Drug Administration grants accelerated approval to Osimertinib for Non-Small Cell Lung Cancer (NSCLC) Treatment
November 13, 2015
The specific mutation in EGFR that determines the drug as an appropriate therapy occurs at position 790 in the amino acid sequence of the protein, and involves an amino acid substitution changing T to M (T790M). The T790M mutation can be detected in patient tumors using an FDA-approved test.
read more »U.S. Food and Drug Administration (FDA) approved Iressa (gefitinib)
July 13, 2015
For patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by a specific FDA-approved test.
read more »Crizotinib treatment effective against ROS1-positive lung cancer
September 27, 2014
Treatment led to significant tumor shrinkage in 72 percent of treated patients.
read more »U. S. Food and Drug Administration granted accelerated approval to ceritinib
April 29, 2014
The U. S. Food and Drug Administration granted accelerated approval to ceritinib (ZYKADIA, Novartis Pharmaceuticals Corporation) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) with disease progression on or who are intolerant to crizotinib.
read more »Mutated IDH1 identifies brain tumors that benefit from aggressive surgery
February 3,2014
A team led by investigators from the Massachusetts General Hospital have found that patients with malignant astrocytoma – the most common malignant brain tumor – whose tumors carry a mutation in the IDH1 gene benefit greatly from surgical removal of the largest possible amount of tumor.
read more »Multi-institutional team finds targetable BRAF mutations in rare brain tumor
January 12, 2014
A team led by investigators from MGH, Brigham and Women's Hospital and the Broad Institute has found that a gene mutation associated with several types of cancer also may be responsible for a rare but debilitating brain tumor called papillary craniopharyngioma. Their discovery, reported online in Nature Genetics, could lead to new therapies for this currently hard-to-treat tumor.
read more »U. S. Food and Drug Administration granted accelerated approval to trametinib and dabrafenib
January 1, 2014
The U. S. Food and Drug Administration granted accelerated approval to trametinib (Mekinist tablets, GlaxoSmithKline, LLC) and dabrafenib (Tafinlar capsules, GlaxoSmithKline, LLC) for use in combination in the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation as detected by an FDA-approved test.
read more »U. S. Food and Drug Administration approved afatinib
July 12, 2013
On July 12, 2013, the U. S. Food and Drug Administration approved afatinib (Gilotrif tablets, Boehringer Ingelheim Pharmaceuticals, Inc.), for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
read more »MGH-led crizotinib studies shed new light on targeted lung cancer therapy
June 3, 2013
Research teams led by Massachusetts General Hospital (MGH) Cancer Center investigators are publishing two important studies regarding use of the targeted cancer drug crizotinib for treatment of advanced lung cancer driven by specific genetic mutations.
read more »U. S. Food and Drug Administration approved dabrafenib
May 29, 2013
On May 29, 2013, the U. S. Food and Drug Administration (FDA) approved dabrafenib (TAFINLAR capsule, GlaxoSmithKline, LLC), for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.
read more »U. S. Food and Drug Administration approved trametinib
May 29, 2013
On May 29, 2013, the U. S. Food and Drug Administration approved trametinib (MEKINIST tablet, GlaxoSmithKline, LLC), for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutation as detected by an FDA-approved test. Concurrent with this approval, FDA approved the THxID BRAF assay (bioMerieux, Inc.) for detection of BRAF V600E and V600K mutations.
read more »U. S. Food and Drug Administration approved erlotinib
May 14, 2013
On May 14, 2013, the U. S. Food and Drug Administration approved erlotinib (Tarceva, Astellas Pharma Inc.) for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) patients whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
read more »Next-generation PI3 Kinase Inhibitor Demonstrated Early Efficacy, Safety
April 7, 2013
GDC-0032, a potent, next-generation PI3 kinase inhibitor, demonstrated early signs of efficacy for patients with cancers driven by mutations in the PI3 kinase alpha gene, according to first in-human results presented at the AACR Annual Meeting 2013, held in Washington, D.C., April 6-10.
read more »U. S. Food and Drug Administration approved regorafenib
February 25, 2013
The U.S. Food and Drug Administration today expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease.
read more »BRAF inhibitor treatment causes melanoma cells to shift how they produce energy
March 8, 2013
A multi-institutional study has revealed that BRAF-positive metastatic malignant melanomas develop resistance to treatment with drugs targeting the BRAF/MEK growth pathway through a major change in metabolism. The findings suggest a strategy to improve the effectiveness of currently available targeted therapies.
read more »Transition in cell type parallels treatment response, disease progression in breast cancer
January 31, 2013
A process that normally occurs in developing embryos – the changing of one basic cell type into another – has also been suspected of playing a role in cancer metastasis. Now a study from MGH Cancer Center researchers has associated this process, called epithelial-mesenchymal transition, with disease progression and treatment response in breast cancer patients.
read more »MGH-led study of dabrafenib and trametinib named among Clinical Research Forum's Top 10 Clinical Research Achievements of 2012
September 29, 2012
Combined treatment with two drugs targeting different points in the same growth-factor pathway delayed the development of treatment resistance in patients with BRAF-positive metastatic malignant melanoma.
read more »Cancer Center team identifies potential treatment target for KRAS
Feb 16, 2012
Researchers from the Massachusetts General Hospital (MGH) Cancer Center have identified a new potential strategy for treating colon tumors driven by mutations in the KRAS gene, which usually resist both conventional and targeted treatments.
read more »Combination of targeted drugs delays resistance in melanoma patients
October 01, 2012
Combined treatment with two drugs targeting different points in the same growth-factor pathway delayed the development of treatment resistance in patients with BRAF...
read more »Mass. General study defines a new genetic subtype of lung cancer
January 31, 2012
A report from investigators at the Massachusetts General Hospital (MGH) Cancer Center has defined the role of a recently identified gene abnormality in a deadly form of lung cancer. Tumors driven by rearrangements in the ROS1 gene represent 1 to 2 percent of non-small-cell lung cancers (NSCLC), the leading cause of cancer...
read more »Novel gene mutations associated with bile duct cancer
January 18, 2012
Investigators at the Massachusetts General Hospital (MGH) Cancer Center have identified a new genetic signature associated with bile duct cancer, a usually deadly tumor for which effective treatment currently is limited...
read more »The path to personalized treatment
March 28, 2012
In the largest study of its kind, researchers have profiled genetic changes in cancer with drug sensitivity in order to develop a personalized approach to cancer treatments.
read more »New lung cancer pill highlights improved way of treating patients
Aug. 30, 2011
A new drug to combat a certain type of lung cancer is being hailed today as an "amazing development" by medical experts. The drug crizotinib (Xalkori), manufactured by Pfizer and approved last week by the Food and Drug Administration, is intended...
read more »First credible treatment option for metastatic melanoma
August 26, 2010
One targeted cancer therapy nearing clinical application illustrates why patients and their families have new hope as a result of such therapies. Scientists have known for some time that the most commonly mutated gene in melanoma – a leading cause of death in young adults – is called BRAF. However, efforts to disable this mutation...
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