Amgen, J&J Lead Drug Approval NewsBy
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Amgen and J&J.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, July 19, 2017 to Tuesday July 25, 2017.
FDA Approves J&J Severe Plaque Psoriasis Drug
The US Food and Drug Administration (FDA) has approved Johnson & Johnson’s (J&J) Janssen Biotech’s Tremfya (guselkumab) for treating adults living with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Tremfya is a biologic that selectively blocks IL-23, a cytokine that plays a key role in plaque psoriasis, according to information from J&J.
Applications seeking approval in the European Union, Japan and other countries are currently under review.
Approval comes after an expedited regulatory review following application of an FDA Priority Review Voucher.
Source: Johnson & Johnson
FDA Grants Amgen Full Approval for Leukemia Drug
The US Food and Drug Administration (FDA) has approved Amgen’s supplemental biologics license application (sBLA) for Blincyto (blinatumomab) to include overall survival data from a Phase III study for treating relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children. The approval converts Blincyto’s accelerated approval to a full approval.
In May 2017, the FDA approved the sBLA for the administration of Blincyto to be infused over seven days with preservative, which added to the previously approved administration options for infusion over 24 and 48 hours preservative-free and allowing physicians to customize a treatment plan.
Blincyto is a bispecific CD19-directed CD3 T-cell engager (BiTE) antibody construct that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells.
It was previously granted breakthrough therapy designation and accelerated approval in December 2014 by the FDA. In November 2015, Blincyto was granted conditional marketing authorization in the European Union by the European Medicines Agency for treating Ph-relapsed or refractory B-cell precursor ALL. Additional regulatory applications are underway and have been submitted to health authorities worldwide.
BiTE antibody constructs are a type of immunotherapy being investigated for fighting cancer by helping the body’s immune system to detect and target malignant cells. The modified antibodies are designed to engage two different targets simultaneously, thereby juxtaposing T cells to cancer cells, according to Amgen.
FDA OKs Puma Biotechnology’s Breast Cancer Drug
The US Food and Drug Administration (FDA) has approved Puma Biotechnology’s Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cancer, Nerlynx is an extended adjuvant therapy, a form of therapy that is taken after an initial treatment to further lower the risk of the cancer coming back.
Nerlynx is indicated for adult patients who have been previously treated with a regimen that includes the drug trastuzumab, the active ingredient in Roche’s Herceptin.
Nerlynx is a kinase inhibitor that works by blocking several enzymes that promote cell growth, according to Puma Biotechnology, a Los Angeles, California-based biopharmaceutical company.
Source: FDA and Puma Biotechnology