J&J, AstraZeneca, and Mylan Lead Drug Approval News
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Johnson & Johnson, AstraZeneca, and Mylan.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday February 14, 2018 date to Tuesday February 20, 2018.
FDA OKs J&J’s Prostate Cancer Drug
The US Food and Drug Administration (FDA) has approved Erleada (apalutamide), an androgen receptor (AR) inhibitor, from the Janssen Pharmaceutical Companies of Johnson & Johnson for treating patients with non-metastatic castration-resistant prostate cancer (NM-CRPC).
Erleada is an AR inhibitor that binds directly to the ligand-binding domain of the AR. The drug is designed to inhibit AR nuclear translocation, inhibit DNA binding, and impede AR-mediated transcription.
FDA Approves New Use for AstraZeneca’s Cancer Drug Imfinzi
The US Food and Drug Administration (FDA) has approved a new indication for Imfinzi (durvalumab) from AstraZeneca and MedImmune, its global biologics research and development arm, for treating patients with unresectable Stage III non-small cell lung cancer (NSCLC).
Specifically, the new use was approved for those with NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT).
Imfinzi is a human monoclonal antibody that binds to programmed death-ligand 1 (PD-L1) and blocks the interaction of PD-L1 with programmed death-1 and CD80 on T cells.
Imfinzi has received accelerated approval in the US for treating patients with locally advanced or metastatic urothelial carcinoma (bladder cancer), who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within a year of receiving platinum-containing chemotherapy before or after surgery.
FDA Grants Mylan Tentative Approval for Combination HIV Drug
The US Food and Drug Administration (FDA) has granted tentative approval for Mylan’s new drug application for dolutegravir, emtricitabine, and tenofovir alafenamide tablets, for treating human immunodeficiency virus (HIV). This was approved under the US President’s Emergency Plan for AIDS Relief, a five-year bilateral commitment by the US Government to support HIV/AIDS treatment programs in developing countries.
Mylan says its antiretroviral (ARV) will be immediately available in developing countries as a first-line regimen for people being treated for HIV/AIDS.
Mylan’s ARV is a once-daily, fixed-dose combination of the individual components that make up ViiV Healthcare’s Tivicay (dolutegravir) and Gilead Sciences’ Descovy (emtricitabine and tenofovir alafenamide). Mylan manufactures these products under licenses from the Medicines Patent Pool, a United Nations-backed public health organization, and Gilead Sciences, respectively. This is the first tentative approval of tenofovir alafenamide and comes two years after the FDA approval of Gilead Sciences’ Descovy.