BMS, Novartis Lead Drug Approval News

A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Bristol-Myers Squibb and Novartis.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday April 11, 2018 date to Tuesday April 17, 2018.

FDA OKs New Use for Novartis’ Cancer Drug Afinitor
The US Food and Drug Administration has approved a new use for Novartis’ Afinitor Disperz (everolimus) tablets for oral suspension for the adjunctive treatment of adult and pediatric patients aged 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures.

Everolimus is also approved for two other manifestations of TSC: TSC-associated subependymal giant cell astrocytoma and TSC-associated renal angiomyolipoma.

The drug was first approved by the FDA in 2009 for treating advanced renal cell carcinoma and was subsequently approved for treating other forms of cancer: advanced hormone receptor-positive, HER2-negative breast cancer, pancreatic neuroendocrine tumor (a form of pancreatic cancer), and neuroendocrine tumor (NET) (a type of cancer) of the stomach and intestine (gastrointestinal) or lung.

Source: FDA

FDA OKs BMS’ Opdivo, Yervoy as Combination Therapy for Kidney Cancer
The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s (BMS) Opdivo (nivolumab) 3 mg/kg plus BMS’ Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) as a combination therapy for previously untreated patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC).

In October 2015, the immuno-oncology combination regimen of Opdivo and Yervoy received regulatory approval for treating metastatic melanoma and is currently approved in more than 50 countries, including the US and the EU.

Source: Bristol-Myers Squibb

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