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.
Category: FDA Approvals
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.
ALUNBRIG® (Brigatinib)
The FDA on April 28, 2017 granted accelerated approval to ALUNBRIG ® tablets for the treatment of patients with metastatic Anaplastic Lymphoma Kinase (ALK)-positive Non-Small Cell Lung Cancer (NSCLC), who have progressed on or are intolerant to XALKORI® (Crizotinib). ALUNBRIG® is a product of Takeda Pharmaceutical Company Limited, through its wholly owned subsidiary ARIAD Pharmaceuticals, Inc.
RYDAPT® (Midostaurin)
The FDA on April 28, 2017 approved RYDAPT® for the treatment of adult patients with newly diagnosed Acute Myeloid Leukemia (AML) who are FLT3 mutation-positive (FLT3+), as detected by an FDA-approved test, in combination with standard Cytarabine and Daunorubicin induction and Cytarabine consolidation. RYDAPT® is a product of Novartis Pharmaceuticals Corp.