oncology approvals pandemic FDA biosimilar oncology COVID-19

Oncology approvals in 2020: a year of firsts in the midst of a pandemic

by Laleh Amiri-Kordestani & Richard Pazdur

Jan 29^th 2021
4 mins
Nature Reviews Clinical Oncology volume 18, pages 129–130

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Summary

Despite the global COVID-19 pandemic, 2020 was an active year for the OCE. In 2021, the OCE is engaging in Project 2025, an effort to envision the next 5 years in oncology drug development and leverage our resources and talents to improve collaboration with stakeholders to move the field forward as quickly as possible. The US FDA approved 30 new drugs and biologic agents, 45 supplemental drug and biologic applications and 1 biosimilar application in oncology.

To limit potential exposure to SARS-CoV-2, in 2020 the FDA made several approvals aimed at reducing the frequency of interactions between patients with cancer and their health-care providers. These approaches included increasing dosing intervals, such as that for pembrolizumab (which was extended from 3 weeks to 6 weeks), and adopting oral or subcutaneous formulations of already approved drugs.

New formulations approved in 2020 included three different intravenous dosing regimens of atezolizumab, the first oral tablet combining decitabine plus cedazuridine, a subcutaneously injectable combination of daratumumab plus hyaluronidase-fihj, and a fixed-dose combination of pertuzumab, trastuzumab and hyaluronidase–zzxf. Both subcutaneous combinations can be administered in the outpatient setting or the patient’s home by health-care professionals....

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oncology approvals, pandemic, FDA, biosimilar, oncology