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.
Category: FDA Approvals
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.
KEYTRUDA® (Pembrolizumab)
The FDA on May 18, 2017 granted regular approval to KEYTRUDA® for patients with locally advanced or metastatic Urothelial Carcinoma, who have disease progression during or following Platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with Platinum-containing chemotherapy. KEYTRUDA® is a product of Merck and Co., Inc.
KEYTRUDA® (Pembrolizumab)
The FDA on May 10, 2017 granted accelerated approval to KEYTRUDA® in combination with ALIMTA® (Pemetrexed) and Carboplatin for the treatment of patients with previously untreated metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC). KEYTRUDA® is a product of Merck and Co., Inc.
FDA Approves Subcutaneous RITUXAN® Formulation for CD20-Positive Hematologic Malignancies
The US FDA on June 22, 2017, granted regular approval to the combination of RITUXAN® (Rituximab) and Hyaluronidase human (RITUXAN HYCELA®) for adult patients with Follicular Lymphoma, Diffuse Large B-Cell Lymphoma, and Chronic Lymphocytic Leukemia. This Subcutaneous formulation of RITUXAN® utilizes ENHANZE®, a drug delivery technology platform, which removes limitations on the volume of biologics and drugs that can be delivered Subcutaneously, thereby significantly reducing the time required for drug administration. The approval of RITUXAN HYCELA® was based on several randomized clinical trials that demonstrated Non-inferior pharmacokinetics of Subcutaneous RITUXAN HYCELA® compared with IV RITUXAN®, as well as comparable efficacy and safety results.