Pharma in Focus
Email Address Sign-Up

Australia's most trusted source of pharma news

News

Amgen's NSCLC first emerges

Posted 19 January 2021 AM

The TGA has kicked off the new year by handing out provisional approval determinations for a first-in-class lung cancer therapy from Amgen and a new indication for MSD's human papillomavirus (HPV) vaccine.

While the regulatory body does not reveal which indication a provisional approval determination covers, Amgen's KRAS G12C inhibitor sotorasib was previously granted an orphan drug designation specifically for the treatment of patients with locally advanced or metastatic KRASG12C-mutation NSCLC, suggesting the latest designation is likely for the same indication.

Looks like you've lost your access to Pharma in Focus. To restore access or update your subscription, click here

Top of the Hill
How not to reform the PBAC
In the face of deep change, is piecemeal enough?
Approvals Action
New registrations for seizures and HIV
Eisai and ViiV add to their core franchises
Special Report
Aust Covid Vaccine Tracker
UPDATE: Distribution of two mRNA vaccines overseas