The IDEA Collaboration is a prospective, pre-planned pooled analysis of 6 concurrently conducted randomized phase III trials, which included 12,834 patients from 12 countries. They concluded that a risk-based approach has to be taken when making adjuvant chemotherapy recommendations for patients with stage III colon cancer. Three months of adjuvant chemotherapy is adequate for patients with T1-3, N1 disease. This study data was presented at 2017 ASCO Annual Meeting.
Month: July 2017
ENDARI® (L-Glutamine oral powder)
The FDA on July 7, 2017 approved ENDARI® for oral administration to reduce the acute complications of Sickle Cell disease, in adult and pediatric patients 5 years and older. ENDARI® is a product of Emmaus Medical, Inc.
Praxis Extended RAS Panel
The FDA on June 29, 2017 granted marketing approval to the Praxis Extended RAS Panel, a Next Generation Sequencing (NGS) test, to detect certain genetic mutations in RAS genes, in tumor samples of patients with metastatic ColoRectal Cancer (mCRC). The test is used to aid in the identification of patients who may be eligible for treatment with VECTIBIX® (Panitumumab). Praxis Extended RAS Panel is offered by Illumina, Inc.
BEVYXXA® (Betrixaban)
The FDA on June 23, 2017 approved BEVYXXA® for the prophylaxis of Venous ThromboEmbolism (VTE) in adult patients hospitalized for an acute medical illness, who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE. BEVYXXA® is a product of Portola Pharmaceuticals.
TAFINLAR® and MEKINIST® (Dabrafenib and Trametinib) The FDA on June 22, 2017 granted regular approvals to TAFINLAR® and MEKINIST® administered in combination for patients with metastatic Non-Small Cell Lung Cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. TAFINLAR® and MEKINIST® are products of Novartis Pharmaceuticals Inc. These are the first FDA approvals specifically for treatment of patients with BRAF V600E mutation-positive metastatic NSCLC.
The FDA on June 22, 2017 granted regular approvals to TAFINLAR® and MEKINIST® administered in combination for patients with metastatic Non-Small Cell Lung Cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. TAFINLAR® and MEKINIST® are products of Novartis Pharmaceuticals Inc. These are the first FDA approvals specifically for treatment of patients with BRAF V600E mutation-positive metastatic NSCLC.
The FDA today also approved the Oncomine™ Dx Target Test (Thermo Fisher Scientific), a Next Generation Sequencing (NGS) test to detect multiple gene mutations for lung cancer in a single test from a single tissue specimen. This test detects the presence of BRAF, ROS1, and EGFR gene mutations or alterations in tumor tissue of patients with NSCLC. This test can be used to select patients with NSCLC with the BRAF V600E mutation for treatment with the combination of TAFINLAR® and MEKINIST®. This is the first NGS oncology panel test approved by the FDA for multiple companion diagnostic indications.
RITUXAN HYCELA® (Rituximab and Hyaluronidase human)
The FDA on June 22, 2017 granted regular approval to RITUXAN HYCELA® for adult patients with Follicular lymphoma, Diffuse Large B-Cell Lymphoma, and Chronic Lymphocytic Leukemia. RITUXAN HYCELA® is a product of Genentech Inc.
RITUXAN HYCELA® (Rituximab and Hyaluronidase human)
The FDA on June 22, 2017 granted regular approval to RITUXAN HYCELA® for adult patients with Follicular lymphoma, Diffuse Large B-Cell Lymphoma, and Chronic Lymphocytic Leukemia. RITUXAN HYCELA® is a product of Genentech Inc.
GLEOLAN® (AminoLevulinic Acid Hydrochloride)
The FDA on June 6, 2017 approved GLEOLAN® as an optical imaging agent, indicated in patients with Gliomas (suspected World Health Organization Grades III or IV on preoperative imaging), as an adjunct for the visualization of malignant tissue during surgery. GLEOLAN® is a product of NX Development Corp.
ZYKADIA® (Ceritinib)
The FDA on May 26, 2017 granted regular approval to ZYKADIA®, for patients with metastatic Non-Small Cell Lung Cancer (NSCLC), whose tumors are Anaplastic Lymphoma Kinase (ALK)-positive, as detected by an FDA-approved test. ZYKADIA® is a product of Novartis Pharmaceuticals Corp.
KEYTRUDA® (Pembrolizumab)
The FDA on May 23, 2017 granted accelerated approval to KEYTRUDA® for adult and pediatric patients with unresectable or metastatic, MicroSatellite Instability-High (MSI-H) or MisMatch Repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or with MSI-H or dMMR ColoRectal Cancer that has progressed following treatment with a Fluoropyrimidine, Oxaliplatin, and Irinotecan. KEYTRUDA® is a product of Merck and Co., Inc.