Roche Leads Drug Approval NewsBy
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Roche and Neurocrine Biosciences.
Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday April 12, 2017 to Tuesday April 18, 2017.
FDA OKs New Indication for Roche’s Bladder Cancer Drug
Genentech, a member of the Roche Group has received accelerated approval from the US Food and Drug Administration (FDA) for the use of Tecentriq (atezolizumab) to treat locally advanced or metastatic urothelial carcinoma (mUC) in patients who are not eligible for cisplatin chemotherapy.
Tecentriq was previously approved for treating locally advanced or mUC in patients who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). Urothelial carcinoma also includes cancers of the urethra, ureters, and renal pelvis.
The FDA’s accelerated approval program allows conditional approval of a medicine that fills an unmet medical need for a serious condition, based on early evidence suggesting clinical benefit. The new indication for Tecentriq was approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Tecentriq is now approved for three indications: locally advanced or metastatic urothelial carcinoma (mUC) in patients who are not eligible for cisplatin chemotherapy; locally advanced or mUC in patients who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant); and metastatic non-small cell lung cancer.
FDA OKs Roche’s Eye Drug for Diabetic Retinopathy
Genentech, a member of the Roche Group, has received approval from the US Food and Drug Administration (FDA) for Lucentis (ranibizumab injection) 0.3 mg for the monthly treatment of all forms of diabetic retinopathy. The approval is in addition to Lucentis’ indications for treating wet age-related macular degeneration (AMD), macular edema after retinal vein occlusion, diabetic macular edema (DME), diabetic retinopathy, and myopic choroidal neovascularization (CNV). Lucentis is among Roches top-10 selling drugs with 2016 sales of CHF 1.4 billion ($1.4 billion).
The FDA granted Lucentis priority review for treating diabetic retinopathy without DME and had previously granted Lucentis breakthrough therapy designation for diabetic retinopathy in 2014. Lucentis is a vascular endothelial growth factor (VEGF) inhibitor developed by Genentech and Roche retains commercial rights to the drug in the US. Novartis has exclusive commercial rights for the rest of the world. Outside the US, Lucentis is approved in more than 110 countries to treat wet AMD, DME, central retinal vein occlusion, and visual impairment due to CNV.
FDA OKs Neurocrine’s Drug for Tardive Dyskinesia
Neurocrine Biosciences, a San Diego, California-based biopharmaceutical company, has received approval from the US Food and Drug Administration (FDA) for Ingrezza (valbenazine) capsules for treating tardive dyskinesia (TD), an involuntary muscle-movement disorder. Ingrezza will be made available through a select pharmacy network.
Ingrezza, developed by Neurocrine, is a selective vesicular monoamine transporter 2 inhibitor that can be taken together with psychiatric medications such as antipsychotics or antidepressants. It was granted breakthrough therapy designation by the FDA for treating TD, and the new drug application was evaluated by the FDA with priority review.
TD is characterized by uncontrollable, abnormal, and repetitive movements of the trunk, extremities and/or face, which is a condition caused by treatments that block dopamine receptors in the brain, such as antipsychotics and other medications commonly prescribed to treat mental illnesses such as schizophrenia, bipolar disorder, and depression.
Source: Neurocrine Biosciences