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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.

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