The FDA on August 2, 2017 approved IMBRUVICA® for the treatment of adult patients with chronic Graft Versus Host Disease (cGVHD), after failure of one or more lines of systemic therapy. This is the first FDA-approved therapy for the treatment of cGVHD. IMBRUVICA® is a product of Pharmacyclics LLC.
Category: FDA Approvals
IDHIFA® (Enasidenib)
The FDA on August 1, 2017 granted regular approval to IDHIFA®, for the treatment of adult patients with relapsed or refractory Acute Myeloid Leukemia with an Isocitrate DeHydrogenase-2 (IDH2) mutation, as detected by an FDA-approved test. IDHIFA® is a product of Celgene Corp.
OPDIVO® (Nivolumab)
The FDA on August 1, 2017 granted accelerated approval to OPDIVO®, for the treatment of patients 12 years and older with MisMatch Repair deficient (dMMR) and MicroSatellite Instability High (MSI-H) metastatic ColoRectal Cancer, that has progressed following treatment with a Fluoropyrimidine, Oxaliplatin, and Irinotecan. OPDIVO® is a product of Bristol-Myers Squibb Company.
FDA Approves RYDAPT® for FLT3-Mutated Acute Myeloid Leukemia
The FDA on April 28, 2017 approved RYDAPT® (Midostaurin), a multikinase inhibitor, 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. Activating mutations in the FLT3 receptor is the most common genetic abnormality in AML and is detected in approximately 30% of the patients. RYDAPT® along with chemotherapy significantly improved Overall Survival and represents a new standard of care for FLT3-mutated AML patients.
BLINCYTO® (Blinatumomab)
The FDA on July 11, 2017 approved BLINCYTO® for the treatment of relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia (ALL) in adults and children. BLINCYTO® is a product of Amgen Inc.
NERLYNX ® (Neratinib)
The FDA on July 17, 2017 approved NERLYNX ® for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant Trastuzumab-based therapy. NERLYNX ® is a product of Puma Biotechnology, Inc.
FDA’s First Tissue/Site-Agnostic Approval
The FDA for the first time approved a cancer treatment based on specific genetic biomarker, rather than location in the body where the tumor originated. KEYTRUDA®, an anti-PD1 monoclonal antibody was granted accelerated approval for treatment of 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. MMR gene deficiency can be detected by ImmunoHistoChemistry and MSI testing is performed using a PCR based assay.
FDA Approves ENDARI® for Sickle Cell Disease
The FDA on July 7, 2017 approved ENDARI® (L-Glutamine oral powder) for oral administration to reduce the acute complications of Sickle Cell disease, in adult and pediatric patients 5 years and older. There is a higher L-glutamine utilization in Sickle Cell Anemia resulting in its depletion and thereby contributing to oxidative stress. This oxidative stress is an important contributing factor to hemoglobin polymerization, with polymer formation occurring only in the deoxy state. ENDARI® is the first treatment approved for patients with Sickle Cell disease in almost 20 years.
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.