ARZERRA® (Ofatumumab): The FDA on April 17, 2014 approved ARZERRA® in combination with LEUKERAN® (Chlorambucil), for the treatment of previously untreated patients with Chronic Lymphocytic Leukemia (CLL), for whom FLUDARA® (Fludarabine) based therapy is considered inappropriate. ARZERRA® first received accelerated approval in 2009, for the treatment of patients with CLL, refractory to FLUDARA® and CAMPATH® (Alemtuzumab). ARZERRA® injection is given as an intravenous infusion and is a product GlaxoSmithKline.
Category: FDA Approvals
IMBRUVICA® (Ibrutinib)
The FDA on February 12, 2014 granted accelerated approval to IMBRUVICA® for the treatment of patients with Chronic Lymphocytic Leukemia (CLL) who have received at least one prior therapy. The FDA initially granted accelerated approval in November, 2013, for the treatment of patients with Mantle Cell Lymphoma (MCL) who have received at least one prior therapy. IMBRUVICA® is an oral capsule and is a product of Pharmacyclics, Inc.
MEKINIST® (Trametinib) in combination with TAFINLAR® (Dabrafenib)
The FDA on January 10, 2014 approved the use of MEKINIST® in combination with TAFINLAR® for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutation, as detected by an FDA-approved test. Both MEKINIST® and TAFINLAR® are products of GlaxoSmithKline, LLC.
NEXAVAR® (Sorafenib)
The FDA on November 22, 2013 approved NEXAVAR® for the treatment of locally recurrent or metastatic, progressive, Differentiated Thyroid Carcinoma (DTC), refractory to radioactive iodine treatment. NEXAVAR® was previously approved for the treatment of Renal Cell Carcinoma in 2005 and HepatoCellular Carcinoma in 2007. NEXAVAR® tablets are a product of Bayer Healthcare Pharmaceuticals Inc.
IMBRUVICA ® (Ibrutinib)
The FDA on November 13, 2013 granted accelerated approval to IMBRUVICA ® for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. IMBRUVICA ® is an oral capsule and is a product of Pharmacyclics, Inc.
GAZYVA® (Obinutuzumab)
The FDA on November 1, 2013 approved GAZYVA® for use in combination with Chlorambucil (LEUKERAN®), for the treatment of patients with previously untreated Chronic Lymphocytic Leukemia (CLL). GAZYVA® is an injection, for intravenous use and is a product of Genentech, Inc.
PERJETA® (Pertuzumab) The FDA on September 30, 2013 approved PERJETA® for use in combination with HERCEPTIN® (Trastuzumab) and TAXOTERE® (Docetaxel) for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. This combination was approved by the FDA in June 2012, for the treatment of patients with HER2-positive metastatic breast cancer
The FDA on September 30, 2013 approved PERJETA® for use in combination with HERCEPTIN® (Trastuzumab) and TAXOTERE® (Docetaxel) for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. This combination was approved by the FDA in June 2012, for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. PERJETA® is an injection and is a product of Genentech, Inc.
ABRAXANE® (Paclitaxel albumin-bound particles)
The FDA on September 6, 2013 approved ABRAXANE® for use in combination with GEMZAR® (Gemcitabine) for the first line treatment of patients with metastatic adenocarcinoma of the pancreas. ABRAXANE® is an injectable suspension and is a product of Celgene Corporation.
GILOTRIF® (Afatinib)
The FDA on July 12, 2013 approved the use of GILOTRIF® tablets 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. The FDA also approved THERASCREEN, a test provided by QIAGEN, for the detection of EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. GILOTRIF® is a product of Boehringer Ingelheim Pharmaceuticals, Inc.
REVLIMID® (Lenalidomide)
The FDA on June 5, 2013 approved REVLIMID® capsules for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included VELCADE® (Bortezomib). REVLIMID® is a product of Celgene Corporation.