The FDA on December 19, 2017 granted accelerated approval to BOSULIF® for treatment of patients with newly-diagnosed Chronic Phase (CP) Philadelphia chromosome positive (Ph+) Chronic Myelogenous Leukemia (CML). BOSULIF® is a product of Pfizer Inc.
Category: FDA Approvals
FoundationOne CDx (F1CDx)
The FDA on November 30, 2017, granted marketing approval to the FoundationOne CDx, a Next Generation Sequencing (NGS) based in vitro diagnostic (IVD) to detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. The test can also identify which patients with Non-Small Cell Lung Cancer (NSCLC), melanoma, breast cancer, colorectal cancer, or ovarian cancer may benefit from 15 different FDA-approved targeted treatment options. This test is offered by Foundation Medicine, Inc.
SUTENT® (Sunitinib malate)
The FDA on November 16, 2017, approved SUTENT® for the adjuvant treatment of adult patients at high risk of recurrent Renal Cell Carcinoma, following nephrectomy. SUTENT® is a product of Pfizer Inc.
GAZYVA® (Obinutuzumab)
The FDA on November 16, 2017, granted regular approval to GAZYVA® in combination with chemotherapy, followed by GAZYVA® monotherapy, in patients achieving at least a Partial Remission, for the treatment of adult patients with previously untreated Stage II bulky, III, or IV Follicular Lymphoma (FL). GAZYVA® is a product of Genentech, Inc.
SPRYCEL® (Dasatinib)
The FDA on November 9, 2017, granted regular approval to SPRYCEL®, for the treatment of pediatric patients with Philadelphia chromosome-positive (Ph+) Chronic Myeloid Leukemia (CML) in the Chronic Phase. SPRYCEL® is a product of Bristol-Myers Squibb Co.
ADCETRIS® (Brentuximab vedotin)
The FDA on November 9, 2017 granted regular approval to ADCETRIS®, for the treatment of adult patients with primary cutaneous Anaplastic Large Cell Lymphoma (pcALCL) or CD30-expressing Mycosis Fungoides (MF), who have received prior systemic therapy. ADCETRIS® is a product of Seattle Genetics, Inc.
ALECENSA® (Alectinib)
The FDA on November 6, 2017, granted regular approval to ALECENSA®, for treatment of patients with Anaplastic Lymphoma Kinase (ALK)-positive metastatic Non-Small Cell Lung Cancer (NSCLC), as detected by an FDA-approved test. ALECENSA® is a product of Hoffmann-La Roche, Inc./Genentech, Inc.
ZELBORAF® (Vemurafenib)
The FDA on November 6, 2017, granted regular approval to ZELBORAF® for the treatment of patients with Erdheim-Chester Disease (ECD) with BRAF V600 mutation. ZELBORAF® is a product of Hoffmann-La Roche Inc.
CALQUENCE® (Acalabrutinib)
The FDA on October 31, 2017 granted accelerated approval to CALQUENCE® for treatment of adult patients with Mantle Cell Lymphoma (MCL) who have received at least one prior therapy. CALQUENCE® is a product of AstraZeneca Pharmaceuticals Inc. under license of Acerta Pharma BV.
YESCARTA® (Axicabtagene ciloleucel)
The FDA on October 18, 2017 granted regular approval to YESCARTA®, for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including Diffuse Large B-Cell Lymphoma (DLBCL) Not Otherwise Specified, Primary Mediastinal large B-cell Lymphoma, high-grade B-cell lymphoma, and DLBCL arising from Follicular lymphoma. YESCARTA® is a product of Kite Pharma, Inc.