The FDA on July 17, 2017 approved NERLYNX® (Neratinib) for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant Trastuzumab (HERCEPTIN®)-based therapy. NERLYNX® is a potent, irreversible, oral Tyrosine Kinase Inhibitor, of HER1, HER2 and HER4 (pan-HER inhibitor). NERLYNX® is the first TKI approved by the FDA, shown to reduce the risk for disease recurrence, in patients with early stage HER2-positive breast cancer and demonstrated significantly improved 2-year invasive Disease Free Survival.
Category: FDA Approvals
MVASI® (Bevacizumab-awwb)
The FDA on September 14, 2017 approved MVASI® as a biosimilar to AVASTIN® (Bevacizumab). MVASI® is the first biosimilar approved in the U.S. for the treatment of cancer, and is a product of Amgen Inc.
KYMRIAH® (Tisagenlecleucel)
The FDA on August 30, 2017 granted regular approval to KYMRIAH®, for the treatment of patients up to age 25 years with B-cell precursor Acute Lymphoblastic Leukemia (ALL), that is refractory or in second or later relapse. KYMRIAH® is a product of Novartis Pharmaceuticals Corp.
FDA Approves First Biosimilar for Cancer Treatment
The FDA on Sept. 14, 2017 approved MYASI® (Bevacizumab-awwb) as a Biosimilar to AVASTIN® (Bevacizumab). MYASI® is the first Biosimilar approved in the U.S. for the treatment of cancer. A Biosimilar must show that it has no clinically meaningful differences in terms of safety and effectiveness from the already approved biological product (also known as reference product). A Biosimilar product can only be approved by the FDA if it has the same mechanism of action, route of administration, dosage form and strength as the reference product, and only for the indications and conditions of use, that have been approved for the reference product. The approval of MYASI® was based on comparisons of extensive structural and functional product characterization, animal data, human PharmacoKinetic and pharmacodynamic data, clinical immunogenicity, between MYASI® and AVASTIN® (Bevacizumab), and it was noted that MYASI® is highly similar to AVASTIN® and that there are no clinically meaningful differences between the two products.
First CAR T-Cell Immunotherapy Approved by the FDA for Acute Lymphoblastic Leukemia
The FDA on August 30, 2017, granted regular approval to KYMRIAH® (Tisagenlecleucel) for the treatment of patients up to age 25 years with B-cell precursor Acute Lymphoblastic Leukemia (ALL), that is refractory or in second or later relapse. KYMRIAH® is the first Chimeric Antigen Receptor (CAR) T-cell immunotherapy approved by the FDA. A single infusion of KYMRIAH® was highly efficacious, in patients with relapsed and refractory ALL, and was associated with a high and durable Remission Rate. This technology may be applied to other malignancies, as new antigen targets are identified.
FDA Approves DARZALEX® in Combination with POMALYST® and Dexamethasone for Relapsed or Refractory Multiple Myeloma
The FDA on June 16, 2017 approved the use of DARZALEX® (Daratumumab) in combination with POMALYST® (Pomalidomide) and Dexamethasone for the treatment of patients with Multiple Myeloma who have received at least two prior therapies including REVLIMID® (Lenalidomide) and a Proteasome Inhibitor. DARZALEX® is a human IgG1 antibody that targets CD38, a transmembrane glycoprotein abundantly expressed on malignant plasma cells. This combination may be a viable option for patients who progress on a combination of REVLIMID®, VELCADE® and Dexamethasone (RVD) regimen, which is often given as first line therapy.
FDA Approves OPDIVO® for MSI-H or dMMR Metastatic Colorectal Cancer
The FDA on July 31, 2017, granted accelerated approval to OPDIVO® (Nivolumab) 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. NCCN Guidelines recommend MMR or MSI testing for all patients with a history of Colon or Rectal cancer. Patients with metastatic ColoRectal Cancer who have dMMR or MSI-H tumors are less likely to respond to conventional chemotherapy and OPDIVO® demonstrated durable responses and disease control in this heavily pretreated patient group.
VYXEOS ® (Liposome-encapsulated combination of Daunorubicin and Cytarabine)
The FDA on August 3, 2017 granted regular approval to VYXEOS ® for the treatment of adults with newly-diagnosed therapy-related AML (t-AML) or AML with Myelodysplasia-Related Changes (AML-MRC), two types of AML having a poor prognosis. VYXEOS ® is a product of Jazz Pharmaceuticals.
IMBRUVICA® (Ibrutinib)
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.
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.